Heart Failure Care Manager Program Protocol

7/25/2019 Heart Failure Care Manager Program Protocol

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SCVMC/AMBULATORY SERVICES: BRN 17CARE MANAGER PROTOCOL Page 1 of 48

Heart Failure. STANDARDS

SANTA CLARA VALLEY MEDICAL CENTERDEPARTMENT OF MEDICINEDIVISION OF CARDIOLOGY

HEART FAILURE CARE MANAGER (HFCM)PROGRAM PROTOCOL

Section Page

Purpose 2

Inclusion Criteria 3

Exclusion Criteria 3

Patient Education 5

List of Terms & Abbreviations 9

Pharmaceutical Management Schematic 10

Vasodilator/BBL Titration Schematic 11

Clinical Follow-up Schematic 12

Protocol A: Loop Diuretic 13

Protocol B: Thiazide Diuretic 18

Protocol C: Angiotensin Converting Enzyme Inhibitor (ACE-I) 22

Protocol D: Angiotensin II Receptor Blocker (ARB) 27

Protocol E: Beta Blocker (BBL) 32

Protocol F: Aldosterone Antagonist 37

Protocol G: Hydralazine/Isosorbide Dinitrate (Hz/ISDN) 41

Protocol H: Digoxin 45


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I. TITLE: Heart Failure Care Manager (HFCM) Program Protocol

II. PURPOSE: To outline the Care Manager (Nurse Coordinator/Clinical Pharmacist) responsibilities in themanagement of medication titration and monitoring in the treatment of adult patients withHeart Failure (HF).

III. LEVEL: Dependent: requires a physician order to initiate. This is a California Board of RegisteredNursing Standardized Procedure.

IV. SUPPORTIVEDATA:

This Protocol is performed by a Registered Nurse (R.N.) or Clinical Pharmacist (Pharm.D.) inthe HFCM Program who has been authorized through evaluation and approved in writing toperform this Protocol. No direct supervision of the Care Manager is required.

Patients enrolled under this HFCM Program are initially evaluated by a Santa Clara ValleyMedical Center (SCVMC) staff cardiologist and/or Care Manager either while hospitalized orin the ambulatory care setting. The Medical Director for the HFCM Program oversees thefollow-up of patient management including medication dosage adjustment, laboratory testing,serial echocardiography, complications, and consultation on medical issues that thesepatients may develop as a result of their disease. All patients must have a Cardiologist onstaff at SCVMC to be eligible for ongoing participation in the Program. Patients with anidentified Cardiologist who is not on staff will not be eligible. In addition, patients acceptedinto the HFCM Program must have a current or pending Primary Care Physician (PCP) tomanage their ongoing medical and healthcare needs..Should the patients not have a PCP orCardiologist on staff and the patients wish to participate in the HFCM Program, referrals shallbe done utilizing the already established methods available to the Ambulatory andCommunity Health Services staff.

It is the goal of the HFCM Program to evaluate, intervene, monitor, and stabilize the patientsdisease status to prevent readmission to the hospital and improve clinical outcomes,functional capacity, and quality of life. If the patient, under the HFCM Program parameters,has achieved this goal and demonstrated successful self-management skills, the patient maybe discharged from the Program. Subsequent care of the patients HF will be transitioned to

the PCP and patients cardiologist of record per the determination of the Medical Director.

V. CONTENT: Heart Fai lure (HF) is a comp lex cl inical synd rome that can result from any st ructu ral orfunc tional cardiac disord er that imp airs the abi l i ty of the ventr icle to fi l l with or eject

blood . The cardinal manifestation s of HF are dyspn ea and fatigue, whic h may l im it

exerc ise to lerance, and f lu id retent ion w hich m ay lead to pulmon ary congest ion and

peripheral edema. Both abno rmal i t ies can impair the function al capacity and qu al i ty of

l i fe of affected individuals, but they do not necess ari ly domin ate the cl inical pictu re at

the same time. Some patients h ave exercise intolerance but l i t t le evidence of fluid

retent ion, whereas oth ers comp la in pr im ar i ly of edema and report few sym ptom s of

dysp nea or fatigue.Because not al l patients have volum e overload at the time of ini t ia l

or subsequent evaluation, the term heart failure is preferred over the older termcongestive heart failure.

Circulation2009 ACC/AHA Heart Failure Guidelines, Hunt et al.,p. e397.


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A. PATIENT INCLUSION CRITERIA

1. Left Ventricular Ejection Fraction (LVEF) systolic dysfunction, as determined by an echocardiogram,with an Ejection Fraction (EF) 40%.

2. Criteria met for NYHA class I, II, III, or IV HF.

3. Criteria met for ACC/AHA stage B, C, or D HF.

Table from JAMA287: 890-897 American College of Cardiology-American Heart Association (ACC-AHA) andNew York Heart Association (NYHA) Classification of Heart Failure

B. PATIENT EXCLUSION CRITERIA

1. Patient in Stage A or who has diastolic dysfunction only on echocardiography.

2. Patient who is pregnant or breast feeding.

3. Patient who is unable to care for self, has no reliable caregiver or family member involvement withcare, or residing in a Skilled Nursing Facility (SNF).

4. Patient enrolled in Palliative Care/Hospice.

5. Patient with Congenital Heart Disease.

6. Patient pending Coronary Artery Bypass Graft (CABG) or Heart Valve replacement/repair surgery.

7. Patient with End Stage Renal Disease (ESRD) with baseline Serum Creatinine (SCr) > 3-4 mg/dLwill be individually assessed by the Medical Director in consultation with Nephrology.

8. Patient with any other diagnosed disease or medical condition that, would significantly limit the lifeexpectancy of the patient and in whom enrollment in the HFCM Program would provide no benefit tothe patient.

9. Patients with known recent history of substance abuse and a positive urine toxicology screen withinthe past six months will be evaluated by the Medical Director on an individual basis in conjunctionwith the Social Services/Case Management Division.


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C. PATIENT ENROLLMENT AND DATA COLLECTION

Patient enrollment in the HFCM Program is voluntary. Once enrolled, patients may choose to opt out atany time. All patients enrolled will have the risks and benefits explained to them as with any patientreceiving care at SCVMC. Should the patient decline enrollment or opt out of the HFCM Program onceenrolled, they will continue to receive care for their HF from the Cardiology Clinic and cardiologist of

record. If the patient agrees to enrollment, the following initial data will be obtained by the Care Managerif not already documented in the patients health record.

A electronic order in the patientsElectronic Health Record (EHR) to enroll the patient and follow theHFCM Program Protocol will be written by the Medical Director or the cardiologist and placed in thehealth record. This electronic order , , will authorize the Care Manager to follow the PharmaceuticalManagement Schematic, the Vasodilator and Beta Blocker Titration Schematic, the Clinical Follow-UpSchematic, and subsequent Protocols A-G for specific medication addition and titration.

Patient data collection will include the following which will be kept in the patients EHR

1. Demographics: name, address, date of birth, Medical Record Number (MRN), telephone numbers,any other contact information for patient and an emergency contact name and telephone number.

2. History: significant Past Medical History (PMH) including duration and etiology (if known) of HF,Stage or Functional Classification of HF, physiologic type of HF, significant risk factors and co-morbidities, any Venous Thromboembolism (VTE), any significant arrhythmia leading to AlteredLevel of Consciousness (ALOC), any device-based therapy, and lifestyle issues that may adverselyaffect the heart.

3. Hemodynamic assessment: vital signs, including SpO2, and Body Mass Index (BMI).

4. Cardiac rhythm: if other than Normal Sinus Rhythm, date (if known) of onset of arrhythmia.

5. Baseline laboratory evaluation:a. Complete Blood Count (CBC) with differentialb. International Normalized Ratio (INR)

c. Electrolytes and renal function (Panel 7), Calcium, Magnesiumd. Liver Function Tests (LFTs)e. N-Terminal pro-B-type Natriuretic Peptide(NT-proBNP)f. Fasting Lipid Panel (FLP)g. Thyroid Stimulating Hormone (TSH)h. Iron studes (Ferritin, Iron, Total Iron Binding Capacity)i. Digoxin level (if applicable)

6. Cardiac studies: must have echocardiogram within 4 months prior to enrollment. Additional teststhat may also be documented as having been done include Holter/Event/TranstelephonicMonitoring, coronary angiogram, stress test, nuclear studies, and last documented record of device(Implantable Cardioverter Defibrillator or Cardiac Resynchronization Therapy Defibrillator)interrogation. If tests were done at an outside facility, that information will be documented if

available.

7. Medications: medication reconciliation may be done by physician or Care Manager. All medications,including dietary supplements or herbal remedies, will be documented. All allergies or sensitivities todrugs, food, and Latex will be documented.

8. Patient education is a required component of the HFCM Program and shall include enrollment in

Living with Heart Failureseries and subsequent transition to the Health Education Departmentclasses for patients diagnosed with chronic diseases.


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D. REPORTABLE CONDITIONS

1. The Medical Director or designee of the HFCM Program will be contacted for the following situationsas soon as possible:a. Hypotension: Systolic Blood Pressure 90 mmHg.b. Hypertension: Systolic Blood Pressure 160 mmHg.

c. Changes in renal function reflected in Blood Urea Nitrate (BUN) and Serum Creatinine (SCr)elevations and subsequent decrease in Creatinine Clearance (CrCl) or Glomerular FiltrationRate (GFR) not elsewhere addressed in the Protocol.

d. New onset of arrhythmia, either supraventricular or ventricular.e. New onset of syncope.f. Implantable Cardioverter Defibrillator (ICD) or Cardiac Resynchronization Therapy Defibrillator

(CRT-D) therapy rendered per patient report.g. Critical laboratory value.

2. Patients who report acute onset of symptoms that fall outside the parameters of the Protocol shallbe triaged by the Medical Director or designee as soon as possible for determination of appropriateintervention. Appropriate intervention may include same-day visit to the Cardiology Clinic to beevaluated by a cardiologist or Nurse Practitioner or the Post Admission Transition to CommunityHealth (PATCH) Clinic to see a Hospitalist.

3. Any acute medical problem that the patient reports and is unrelated to HF will be referred to thepatients PCP, Express Care Clinic, or the Emergency Department (ED) as determined by theassessment of the Care Manager. Patients who are stable will be referred to their PCP or ExpressCare Clinic. Patients who are unstable will be directed to call 9-1-1 or go to the EmergencyDepartment.

E. PATIENT EDUCATION

1. Patient education is a key component in achieving successful outcomes for patients with HeartFailure. Patients, who fall under the Exclusion Criteria in Section B, while excluded from enrollmentin the HFCM Program Protocol itself, shall be offered the educational aspect of the HFCM Program.Education goals include the following:

a. The patient will be instructed in self-care as their shared responsibility for the management oftheir disease. Emphasis will be placed on self-management skills, adherence to medicationregimen, obtaining laboratory tests, and follow-up via telephone contact or clinic visit. If thepatient cannot demonstrate these expected outcomes, this may result in early termination fromthe HFCM Program.

b. The Living with Heart Failureseries will provide education and skills in medicationadherence, definition and diagnosis of HF, eating plan, activity program, hypertension andblood pressure monitoring, daily weights, symptom management, living with a chronic disease,co-morbidities, and risk factors.

2. The patient will be transitioned to the Health Education Department classes on living with a chronicdisease: Healthier Living Classes, Advance Care Planning Workshop, Reduce Your Stress, andStaying Smoke-Free.While attendance at these classes is optional, patients shall be encouraged to

participate in those classes that directly impact their cardiac risk factors.

3. Documentation of attendance at the Living with Heart Failureseries and Health EducationDepartment classes will be done and kept in the patients EHR. Failure to attend all classes asrequired may result in early termination from the HFCM Program.


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F. ONGOINGMONITORING ANDDOCUMENTATION

1. All patient contacts, either face-to-face or via telephone, will be documented and kept in thepatients EHR. Ongoing monitoring and documentation shall include, but not be limited to:a. Medication additions or dosage changes per Protocol. Ongoing list of current medications

and/or supplements taken by patient shall be updated as needed.

b. Any requested laboratory testing, ordered under the provider number of the Medical Director,shall be reviewed and any abnormalities documented.

c. All physician notifications by the Care Manager including reason and disposition.d. Any change in the patients health condition shall be documented and referred to the

appropriate provider (cardiologist, PCP, Express Care Clinic, or ED).

2. Monitoring of patient status will focus on predetermined outcome data points reflecting patientimprovement or deterioration in their HF status. The most objective method of assessing patientstatus is with serial echocardiography.a. If the patient has been diagnosed < 6 months prior to enrollment, repeat Transthoracic

Echocardiograms (TTEs) should be obtained every 3 months. This frequency may be reducedat the discretion of the Medical Director.

b. If the patient has been diagnosed > 6 months prior to enrollment, TTEs can be obtained every6-12 months or at the discretion of the Medical Director.

3. Improvement of the LVEF or normalization of the LV size is the optimal objective outcome with thepatient on a stable and optimized medication regimen during the time the patient is in the HFCMProgram. Stable laboratory values, are also to be an expected objective outcome. Repeat NT-proBNP to assess HF status may be ordered at the determination of the Medical Director.

4. Subjective outcomes to be monitored in the patient and documented shall pertain to quality of lifeexpectations in accordance with their NYHA functional classification. Demonstration of patient self-management skills shall also be monitored and documented. In addition, it is expected that thepatient will obtain a weight scale and a blood pressure monitoring device to use daily at home asinstructed. Home monitoring of signs and are needed in order safely titrate the medications includedin this Protocol. Failure to comply with this expectation may result in early termination from theHFCM Program at the discretion of the Medical Director. The patients PCP and cardiologist of

record will be notified of any early termination of the patient from the HFCM Program.

5. Monitoring of patient status will also include documentation of patient adherence with medicationregimen, laboratory testing, and follow-up with clinic visits or telephone contact. Failure to adhere tothe requirements of the HFCM Program shall be considered a safety issue and may be detrimentalto the patients health status. This may result in early termination from the HFCM Program.

6. Patient contact by the Care Manager, after an assessment by the Medical Director or a staffcardiologist, will follow a pattern of alternating clinic visits and telephone contacts. Beginningenrollment into the HFCM Program may require weekly or bi-weekly contacts as neededOnce thepatient has been titrated to their maximum dosage of medications and are considered stable per thecardiologist, patient contact may be extended to monthly or longer intervals per Protocolparameters. At a minimum, all patients will be seen annually by their cardiologist of record.

7. The patients PCP will be notified of the patient enrollment into the HFCM Program. The PCP willreceive regular email updates from the Care Manager. The patient will be referred back to their PCPfor any ongoing medical issues unrelated to their cardiac condition. Should the patient elect to optout of the HFCM Program once enrolled, the PCP and the cardiologist of record will be notified ofthe change in patient status.


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G. PRESCRIPTIONS

1. If the patient is adherent to the medication regimen prescribed to them by the Care Manager,medication refills of those drugs identified in the Protocol may be sent via facsimile to a pharmacy ofthe patients choice, once signed by the Medical Director o r other authorized prescriber.Additionally, changes to the dosage of medication adjusted per Protocol that require a new

prescription for the patient may be sent via facsimile to a pharmacy of the patients choice, oncesigned by the Medical Director or authorized prescriber. If the patient is physically present in theclinic, a prescription may be given to the patient. Documentation of said prescription(s) shall bemade in the patients EHR.

2. Medication additions or changes may be made by the Care Manager while the patient is present inthe clinic or over the telephone. These changes should be implemented as soon as possible, basedon the patients condition. It would be the expectation that patients would be able to obtain their newmedication, or new dosage of medication, in a timely manner. In some cases the patient may not beable to obtain the medication the same day from the pharmacies of SCVMC; the medication mayneed to be mailed out to the patient, resulting in a delay of implementation. This shall bedocumented in the patients record as being outside of the Program parameters. Subsequentpatient evaluation of laboratory studies or symptom assessment shall be adjusted accordingly.

H. REQUIREMENTS OF REGISTERED NURSE

1. Education/Training: Current license by the State of California Board of RegisteredNursing and current position as Nurse Coordinator.

2. Experience: Minimum of 1 year of critical care/ specialty practices.

3. Initial Evaluation: Completion of orientation and competency validation to the Protocol.Competency validation is per the Cardiovascular Center NurseManager and/or the HFCM Program Medical Director.

4. Continuing Evaluation: Annual review of competency and quarterly, random chart audit.

I. REQUIRMENTS OF CLINICAL PHARMACIST

1. Education/Training: Current license by the State of California Board of Pharmacyrequired. Graduate from an accredited School of Pharmacy.Possess a Doctor of Pharmacy degree or equivalent.

2. Experience: Minimum of 1 year as a pharmacist with familiarity in chronic caremanagement.

3. Initial Evaluation: Completion of orientation and competency validation to the Protocol.Competency validation is per the Cardiovascular Center NurseManager and/or the HFCM Program Medical Director.

4. Continuing Evaluation: Annual review of competency and quarterly, random chart audit.

VI. DEVELOPMENT & APPROVAL OF THE STANDARDIZED PROCEDURE

A. Method: Developed and approved by authorized representatives of Administration,Medical Staff, Pharmacy, Case Management, and Nursing.

B. Review: Annual.


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BRN 17 CHF MAR 2014/S/ACHS STANDARDS

SIGNATURES OF AUTHORIZED REPRESENTATIVES:

Director, Ambulatory & Community Health Services (ACHS) Date

Chief Nursing Officer, Santa Clara Valley Medical Center (SCVMC) Date

Medical Director, Ambulatory Care Date

Medical Director, Heart Failure Program, Division of Cardiology Date

Acting Chair, Department of Medicine Date

Chairperson, Pharmacy and Therapeutics (P&T) Committee Date

Chairperson, Interdisciplinary Practice Committee (IDPC) Date

REFERENCES: Farrell M, American College of Cardiology-American Heart Association (ACC-AHA) and New York HeartAssociation (NYHA) Classification of Heart Failure, JAMA287: 890-897.Hunt, SA, Abraham, WT, Chin, MD, Feldman, AM, Francis, GS, Ganiats, TG, Jessup, M, Konstan, MA,Mancini, DM, Michl, K, Oates, JA, Rahko, PS, Silver, MA, Stevenson, LW, Yancy, CW, ACC/AHA 2005Guideline Update for the Diagnosis and Management of Chronic Heart Failure in the Adult, Circulation2005,112:e154-e235.Hunt SA, Abraham WT, Chin MH, Feldman AM, Francis GS, Ganiats TG, Jessup M, Konstam MD, ManciniDM, Michl K, Oates JA, Rahko PS, Silver MA, Stevenson LW, Yancy CW. 2009 Focused updateincorporated into the ACC/AHA 2005 guidelines for the diagnosis and management of heart failure in adults:a report of the American College of Cardiology Foundation/American Heart Association Task Force on

Practice Guideline. Circulation. 2009;119:e391-e479.Jessup M, Abraham WT, Casey De, Feldman AM, Francis GS, Ganiats TG, Konstam MA, Mancini DM,Rahko PS, Silver MA, Stevenson LW, Yancy CW, writing on behalf of the 2005 Guideline Update for theDiagnosis and Management of Chronic Heart Failure in the Adult Writing Committee. 2009 Focused update:

ACCF/AHA guidelines for the diagnosis and management of heart failure in adults: a report of the AmericanCollege of Cardiology Foundation/American Heart Association Task Force on Practice Guidelines.Circulation. 2009:119:1977-2016.Lexi-Comp Online. Lexi-Drugs Online. Hudson, OH: Lexi-Comp, Inc.; 2013.http://online.lexi.com/.Updatedperiodically

RESOURCES: Aravind Swaminathan, MD, Medical Director of the Heart Failure Program, Department of Medicine, Divisionof Cardiology, Santa Clara Valley Medical Center, Ambulatory and Community Health Services.Meenakshi Aggarwal, MD, Department of Medicine, Chief of the Division of Cardiology, Santa Clara ValleyMedical Center, Ambulatory and Community Health Services.Mark Ordway, RN, Nurse Coordinator, Cardiovascular Services, Ambulatory and Community HealthServices.Jessica C. Song, M.A., Pharm.D., Ambulatory Care/Mental Health Clinical Supervisor, Department ofPharmacy Services, Santa Clara Valley Medical Center.Lawrence Dang, Pharm.D., Clinical Pharmacist, Department of Pharmacy Services, Santa Clara ValleyMedical Center.

APPROVED: 12/11 Interdisciplinary Practice CommitteeREVIEW:REVISION: 3/14
http://online.lexi.com/http://online.lexi.com/


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LIST OF TERMS & ABBREVIATIONS

TERMS

Symptomatichypotension:

Condition in which systolic blood pressure is below 90 mmHg or > 10mmHg below baselineand is associated with symptoms of dizziness, lightheadedness, fatigue, headache, or

syncope

Fluid retention: Condition marked by one of the following signs/symptoms: peripheral edema, orthopnea,paroxysmal nocturnal dyspnea, weight gain (of more than 3 pounds in one day or 5 poundsin a week), jugular venous distention, persistent and unexplained fatigue, or adventitiousbreath sounds on auscultation.

Volume depletion: Condition marked by symptoms of dry mouth/thirst, lightheadedness, dizziness, or fatigue,associated with drop in SBP >10mmHg, and rise in pulse > 10 bpm, decreased urine output,and/or prerenal azotemia on laboratory analysis.

Euvolemia: State of normal body fluid volume with no signs/symptoms of fluid retention or volumedepletion with patient at baseline weight and vital signs.

Clinically stable: Condition in which no significant new signs or symptoms exist with evidence of euvolemiaand stable vital signs at baseline.

Angioedema: Rapid swelling (edema) of the dermis, subcutaneous tissue, mucosa, and submucosaltissues.

Prerenal azotemia: Elevation in Blood Urea Nitrogen (BUN) and serum creatinine (SCr) in ratio of BUN:SCr>20.

ABBREVIATIONS

Na+: Sodium SBP: Systolic Blood Pressure ACE-I: Angiotensin Converting

Enzyme InhibitorK

+: Potassium DBP: Diastolic Blood Pressure

ARB: Angiotensin II ReceptorBlockerCl

-: Chloride BPM: Beats Per Minute

Ca+: Calcium ECG: Electrocardiogram BBL: Beta Blocker

Mg+: Magnesium TTE: Transthoracic Echocardiogram CCB: Calcium Channel

BlockerSCr: Serum Creatinine LVEF: Left Ventricular Ejection Fraction

NSAID: Nonsteroidal Anti-Inflammatory DrugCrCl: Creatinine Clearance AMI: Acute Myocardial Infarction

GFR: Glomerular Filtration Rate QOL: Quality of Life

P7: Panel 7

CBC: Complete Blood Count

FORMULAS

Cockcroft-Gault: Use the SCVMC Universal Renal Function Calculator (Department of Pharmacy)

Corrected Sodium(for hyperglycemia):

Measured sodium + [([Serum glucose - 100]/100) x 1.6]


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SCVMC/AMBULATORY SERVICES: HEART FAILURE

CARE MANAGER PROTOCOL Page 10 of 48

SCVMC HF Pharmaceutical Management Schematic

Meet ACE-Icriteria?

Identify reason for intolerance andselect appropriate alternative

vasodilator per titration schematic

If no vasodilators tolerated orcontraindicated, refer to cardiologist.

AdverseReaction

RenalInsufficiency

No

Add and titrateHz/ISDN

(see Protocol G)

Add and titrateARB

(see Protocol D)

Alternative vasodilator tolerated?

Evidence offluid retention?

STARTMeet entry criteria?

Add and titrateLoop Diuretic

(see Protocol A)

Add and titrate ACE-I(see Protocol C and

refer to titrationschematic)

No

Yes

No

Yes

Yes

No

YesYes

Titrate vasodilator per titration schematic to target dose

If HTN (SBP >140 mmHg) present, consider Hz/ISDN (if not already added) orefer to cardiologist for CCB consideration

Persistent HFsymptoms?

Consider addingdigoxin

(see Protocol H)

Is vasodilator attarget or maximum

tolerated dose?

No

Addspironolactone(see Protocol F)

N

Yes

No

Yes

Add and titrate BBL(see Protocol E and

refer to titrationschematic)

Persistent HFsymptoms?

Meetspironolactone

criteria?

Yes

No

Meet BBLcriteria?

Yes


Titrate LoopDiuretic

(see Protocol A)

Yes


Titrate LoopDiuretic

(see Protocol A)


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Key Points

Vasodilators include ACE-Is, ARBs, or Hz/ISDN. BBLs include carvedilol and metoprolol succinate.

Initial priority is to achieve balanced regimen with vasodilators and BBLs prior to maximizing dose of eithermedication.

Goal is to achieve 100% Total Target Daily Dose although patient intolerance may limit dose increase.

Doses of other medications including diuretics, CCBs, and blockers may need to be decreased astolerated to allow for upward titration of the vasodilator and BBL.

Rate of titration of individual medications should be performed per Protocol over a period no shorter than 12weeks. Titration to target doses may be prolonged by side effects (e.g. hypotension or fatigue) precludingrapid dose increase. Strategies to minimize intolerance (such as increasing only nighttime dose of twice

daily meds) should be employed to aid medication dose increase.

SCVMC HF Vasodilator and BBL Titration Schematic

Increase Vasodilator and BBL per Protocols as close to 100% Target Doseas tolerated. Doseincreases should be alternated between agents to achieve balanced HF regimen.

Initiate BBL er Protocol E

Initiate selected Vasodilator perappropriate Protocol (C, D or G)

Titrate selected BBL to maximumtolerated dose not exceeding

50% Target Dose per Protocol

Titrate selected Vasodilator to maximumtolerated dose not exceeding

25% Target Dose per Protocol


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Protocol Timeline

Week 3

Prior to enrollment:

Establish treatment plan

Refer for additionaldiagnostic studies,procedures, interventions

Enroll to HFCM Clinic andbook appointment

QOL assessment

At initial visit:

HF educational classenrollment

Pharmacy education

Medication titration

Additional labs/diagnosticsas needed

At each follow-up visit:

Assess signs andsymptoms

Assess medicationadherence/tolerance

Continue medicationtitration

Additional labs/diagnosticsas needed

Additional notes:

Additional clinic visits or phone contacts may benecessary based on patient symptoms, medicationtolerance or diagnostic test abnormalities

Referral for additional cardiology visits will be left tothe discretion of the Care Manager

Patients may be considered for discharge from theHFCM Clinico Starting at 6 months oro When target doses of medications have been

reachedo Patients may be kept in the program beyond 6

months at the discretion of the Care Managerand Medical Director.

A cardiology consult and/or clinic visit will serve toensure patients meet eligibility criteria for theHFCM Program and also establish a diagnostic andtreatment plan

Goals

HFCM Clinic

Outpatient Provider ReferralInpatient Service Referral

Phone follow-up 1

PATCH ClinicCardiology Clinic

HFCM screen

Cardiology consult

SCVMC HF Clinical Follow-Up Schematic

PCP as needed forongoing care

Cardiology Clinicin 1-4 weeks

Initial visit

Follow-up visit 2

Visit 1

Visit 2 (if needed)

Follow-up visit 3

Week 1

Week 2

Week 4

Follow-up visit

Weeks 6-16

Phone follow-up

every 2 weeks

Follow-up visit

Weeks16-24 every 4 weeks

Phone follow-up

Follow-up visits andphone contactsevery 6-8 weeks

Months 6-12Follow-up visits

every 3-12 months

At target doses:

Repeat limited TTE forassessment of LVEF

Repeat QOL assessment

Consider discharge fromHFCM Clinic


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HFCM PROGRAM

GOAL OFTHERAPY

To reduce edema associated with HF as a specific targeted medication. Treating the signs andsymptoms of HF involves maintaining a euvolemic state. This is best done with the judicioususe of diuretic agents, vasodilator agents, and positive inotropes.

MECHANISMOF ACTION

Inhibits the reabsorption of sodium and chloride in the ascending loop of Henle, resulting in anincreased excretion of water, sodium, chloride, magnesium, and calcium.

DOSAGE Furosemide tablets: 20 mg, 40 mg, 80 mgFORMS

INCLUSION 1. LVEF 40%CRITERIA 2. Patients presenting with signs or symptoms of fluid retention

EXCLUSION 1. Anuria (urine output < 50 mL/day)CRITERIA 2. Hypersensitivity to this compound

3. Uncorrected hypokalemia (K+< 3.5 mmol/L) or hypomagnesemia (Mg

+< 0.7 mmol/L)

4. Inconsistent contraceptive use in women of child bearing age

CAUTION 1. Avoid excess diuresis as seen with rapid and excessive weight loss that may causehypotension (SBP < 90 mmHg) or electrolyte depletion.

2. Monitor for declining renal function with concomitant use of ACE-I as seen with rise ofBUN or SCr, and decrease in CrCl, if outside the normal parameters as reported bylaboratory testing or calculation of lean body mass.

3. This drug may worsen glycemic control in patients with Diabetes Mellitus. Monitor serumglucose in subsequent laboratory tests after increasing furosemide dose. May need torefer to PCP for adjustment of diabetes medications if serum glucose increases andremains elevated.

4. Advise patients with a known diagnosis of gout to treat flares early. Do not use NSAIDs,and contact their PCP as needed.

5. Advise patients about signs and symptoms of fluid and electrolyte imbalance (dry mouth,thirst, weakness, lethargy, drowsiness, restlessness, confusion, seizures, muscle pains orcramps, muscular fatigue, hypotension, oliguria, tachycardia, GI disturbances such asnausea/vomiting) and to notify Care Manager if new onset.

6. Advise patients to possibly lower dose of furosemide during episodes of dehydration fromother causes (nausea/vomiting associated with gastroenteritis) after contacting CareManager.

PROTOCOL A: LOOP DIURETIC


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ALGORITHM: TITRATION STAGESNote: start at Stage 2 if patient has CrCl < 60 mL/min

ALGORITHM: INITIATION / MAINTENANCE

Stage 1

Furosemide 20 mg at 8 AM

Stage 2

Furosemide 40 mg at 8 AM

Stage 3

Furosemide 40 mg at 8 AMFurosemide 40 mg at 2-4 PM

Stage 4


Stage 5


Stage 6



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ALGORITHM: UP-TITRATION

Criteria for increasing dose:

Patient reports weight gain of 3 pounds in one day or 5 pounds in one week.

Patient reports edema or subjectively states that clothing is tight.

Patient reports more dyspnea than usual, orthopnea, or unexplained fatigue that persists.

Patient has signs of fluid retention with JVD or rales on chest auscultation.

ALGORITHM: DOWN-TITRATION

Criteria for decreasing dose:

If the patient experiences dose-related complications unrelated to electrolyte imbalance which can beaddressed with Electrolyte Assessment Table.

In order to allow for up-titration of Vasodilator (ACE I, ARB, Hz/ISDN) or BBL.

If the patient is clinically stable, maintain the current dose of furosemide.

Step 2

Day 4 (Telephone)

Patient to report BP, signs,symptoms and weight

Day 7 (Laboratory monitoring)

Repeat Panel 7

Replace/monitor electrolytes perElectrolyte Assessment Table

Step 1

Day 1 (Clinic or Telephone)

Increase furosemide by 1 stage x3 days

Have patient monitor BP, weight,signs and symptoms daily

In addition to scheduledtelephone contact, tell patient tocall if symptoms worsen or weightcontinues to increase

Step 3

Day 8-14 (Telephone)

If fluid retention has notimproved, go back to Step 1 ofup-titration

If fluid retention improving oreuvolemia achieved, maintaincurrent dose

Consider adding thiazide diureticif total daily furosemide dose>240 mg or if persistent HFsymptoms exist with up-titration

Step 1

Day 1 (Clinic or Telephone)If symptoms have resolved andone of the above criteria are met,decrease furosemide by 1 stage

Repeat Panel 7 within 1 week

Step 2

Day 2-6 (Telephone)If weight gain or symptomsreturn, restart previous doseand try to taper after 4 to 14days if fluid retentionimproves. If patient is not ableto taper diuretic dosing,discuss with cardiologist toestablish new maintenanceregimen.

Step 3

Day 7-14 (Telephone)If there is no increase inweight or symptoms, mayrepeat Step 1 or continuecurrent dose if stablemaintenance dose is attainedby patient.


Obtain Panel 7 if not checkedwithin the past 7 days ofinitiating therapy

Day 2-7 (Telephone)

Assess response (weight within 1 kg of dry weight if known)

If patient does not achieve resolution of fluid retention oreuvolemia, proceed to Step 1 of up-titration (see below)

If response is adequate, continue current dose of furosemide

Day 7 (Laboratory Monitoring)

Obtain Panel

Replace/monitor electrolytes per Electrolyte Assessment Table


16/48



DRUGINTERACTIONS

1. ACE-I and ARB medications may cause postural hypotension in patients with sodiumdepletion or hypovolemia due to diuretics or sodium restriction. This hypotensiveresponse is usually transient. Closely monitor BP.

2. Diuretic-induced hypokalemia may increase risk of digoxin toxicity3. NSAIDs, including COX-2 Inhibitors, may decrease the efficacy of furosemide.4. Alcohol, barbiturates, or narcotics may potentiate orthostatic hypotension.

5. Corticosteroids may potentiate hypokalemia in patients taking diuretics.6. Furosemide therapy may increase cholesterol and triglyceride levels. If patient is oncholestyramine or colestipol, advise patient to take furosemide at least 1 hour before or 4-6 hours after these bile acid sequestrants.

7. Furosemide may increase lithium levels and lithium toxicity. Patients on lithium should bemonitored for alterations in their mental status. Consult with cardiologist if so noted.

FOR DOSE RELATED COMPLICATIONS BELOW: IF PATIENT ON ACE-I OR ARB, CHECK APPROPRIATESECTION OF PROTOCOL C OR D. IF PATIENT ON SPIRONOLACTONE, THEN CHECK PROTOCOL F.

DOSE RELATEDCOMPLICATIONS

1. Symptomatic hypotension: Volume depletion can occur as a result of excessivediuresisthereby leading to reduced BP and renal impairment. However, if the patient haspersistent fluid retention and is hypotensive with SBP < 90mmHg, this could be a sign ofworsening HFindicating a decline in peripheral perfusion.a. If suspect excessive diuresis:

i. Hold 2 days of furosemide dose and restart at 1 stage less than previous dose.ii. Encourage fluid intake for 3 days.iii. Reassess BP and any hypotensive symptoms within 3 days.iv. Repeat Panel 7 in 1 week.v. If symptoms of excessive dieresis persists, repeat steps 1-4 as above. If

symptoms resolve, continue new dose of furosemide as maintenance dose .b. If suspect worsening HF:

i. Consult with Medical Director or cardiologist.2. Prerenal Azotemia: HF patients are at a higher risk of developing this condition due to

poor perfusion of their kidneys as a result of a low CO. Exacerbation by diuretic useincreases the risk. After changing dose of furosemide, watch for sudden increases inBUN and SCr associated with symptoms of hypotension and decreased urine output. If

patient reports symptoms:a. Hold 2 days of furosemide dose and restart at 1 stage less than previous dose.b. Encourage fluid intake for 3 days.c. Reassess BP and any hypotensive symptoms within 3 days.d. Repeat Panel 7 in 1 week.e. If prerenal azotemia persists, repeat steps 1-4 above. If symptoms resolve, continue

new dose of furosemide as maintenance dose.3. Electrolyte abnormalities: hypokalemia, hyponatremia, hypomagnesemia

a. Replace/monitor per Electrolyte Assessment Table.

LABORATORYMONITORINGSCHEDULE

1. Baseline laboratory testing for diuretic therapy shall consist of Electrolyte and RenalFunction test (Panel 7). Check Panel 7 if not done in last 6 months.

2. Medication titration shall follow the above listed time line. At a maximum, laboratory

testing shall be 7-10 days after furosemide dosage change is prescribed andimplemented by the patient. If abnormalities occur, testing shall be more frequentaccording to the severity of the symptoms and previous laboratory values in consultationwith cardiologist.

3. After titration of medication and patient on stable regimen, Panel 7 shall be obtained atleast every 3 months while patient is enrolled in HFCM Program.


17/48



Electrolyte Assessment Table

Hypokalemia

Level of serumpotassium

CreatinineClearance

Oral replacement doseLaboratoryMonitoring

K+

3.13.5 mmol/L

If CrCl > 60ml/min, replaceas noted. If not,

consult withcardiologist.

KCl 40 mEq/day individed dosage with

meals, maintain thisdosage until repeat

Panel 7

Repeat Panel 7 in

one week or earlieras needed

K+ 2.83.0 mmol/L

Consult with MedicalDirector or cardiologist.40 mEq one time doseand then increase dailyreplacement dose by 40mEq in divided dosageswith meals until repeatlaboratory monitoring

Repeat serum K+in

24 hours and thenPanel 7 in 72-96

hours. If patient ondigoxin, check

serum digoxin level,adjust dose per

Protocol H.

K+< 2.8 mmol/L N/A

Consult with MedicalDirector or cardiologist. If

patient symptomatic, sendto ED immediately.

N/A

Hypomagnesemia

Level of serummagnesium

CreatinineClearance


Mg2+

< 0.7 mmol/L N/A

Consult with MedicalDirector or cardiologist.if patient symptomatic,

send to ED immediately

N/A

Hyponatremia

Level of serumsodium

CreatinineClearance


Na+131135mmol/L

N/A

No replacement

Recheck Na+in one

week. If stable orimproved, no

medication change.

Na+125130mmol/L

No replacementMinimize free water

(< 1L/day)Assess symptoms

(mental status changes,seizures) and consult with

Medical Director orcardiologist ifsymptomatic

Recheck Na+

in oneweek and check

fasting bloodglucose for

hyperglycemia. Ifpresent, correct Na

+

for level ofhyperglycemia and

proceed toappropriate

hyponatremiasection. Report

hyperglycemia toPCP and/or DiabeticCare Manager.

Na+< 125 mmol/L

Consult with MedicalDirector or cardiologist.If patient symptomatic,

send to ED immediately.

N/A


18/48




HFCM PROGRAM

GOAL OFTHERAPY

To reduce edema associated with HF as an adjunctive medication to loop diuretics. Treatingthe signs and symptoms of HF involves maintaining a euvolemic state. This is best done withthe judicious use of diuretic agents, vasodilator agents, and positive inotropes.

MECHANISMOF ACTION

Inhibits the reabsorption of sodium in the distal convoluted tubule, resulting in an increasedexcretion of water, sodium, potassium, and chloride.

DOSAGEFORMS Metolazone tablets: 2.5 mg, 5 mg, 10 mgHydrochlorothiazide (HCTZ) tablets: 12.5 mg, 25 mg, 50 mg

INCLUSIONCRITERIA

1. LVEF 40%2. Patients presenting with signs or symptoms of fluid retention despite maximum dose of

furosemide (240 mg/day)

EXCLUSIONCRITERIA

1. Anuria (urine output < 50 mL/day)2. Hypersensitivity to this compound3. Uncorrected hypokalemia (K

+< 3.5 mmol/L), hypomagnesemia (Mg

+< 0.7 mmol/L), or

hypercalcemia (Ca2+

> 10.5 mmol/L)4. Inconsistent contraceptive use in women of child bearing age

CAUTION 1. Avoid excess diuresis as seen with rapid and excessive weight loss that may causehypotension (SBP < 90 mmHg) or electrolyte depletion.

2. Monitor for declining renal function with concomitant use of ACE-I as seen with rise ofBUN or SCr, and decrease in CrCl, if outside the normal parameters as reported bylaboratory testing or calculation of lean body mass.

3. This drug may worsen glycemic control in patients with Diabetes Mellitus. Monitor serumglucose in subsequent laboratory tests after increasing thiazide diuretic dose. May need torefer to PCP for adjustment of diabetes medications if serum glucose increases andremains elevated.

4. Advise patients with a known diagnosis of gout to treat flares early. Do not use NSAIDs,and contact their PCP as needed.

5. Advise patients about signs and symptoms of fluid and electrolyte imbalance (dry mouth,thirst, weakness, lethargy, drowsiness, restlessness, confusion, seizures, muscle pains or

cramps, muscular fatigue, hypotension, oliguria, tachycardia, GI disturbances such asnausea/vomiting) and to notify Care Manager if new onset.

6. Advise patients to possibly lower dose of thiazide diuretic during episodes of dehydrationfrom other causes (nausea/vomiting associated with gastroenteritis) after contacting CareManager.

7. Advise patients about risk of photosensitivity with thiazide diuretics. Stress the importanceof applying sunscreen and protective clothing while outdoors to reduce the risk of severesunburn.

PROTOCOL B: THIAZIDE DIURETIC


19/48



ALGORITHM: TITRATION STAGESNote: Take 30-60 minutes prior to furosemide

Hydrochlorothiazide(use if GFR 40 ml/min)

Metolazone(use if GFR < 40 ml/min)

Stage 1

HCTZ 12.5 mg AMx 3 days

Stage 2

HCTZ 25 mg AMx 3 days

Stage 3

HCTZ 50 mg AMx 3 days

Stage 1

Metolazone 2.5 mg AMx 3 days

Stage 2

Metolazone 5 mg AMx 3 days

Stage 3

Metolazone 5 mg BIDx 3 days


20/48



ALGORITHM: UP-TITRATION

Criteria for adding on and increasing dose:

Patient reports weight gain of 3 pounds in one day or 5 pounds in one week.

Patient reports edema or subjectively states that clothing is tight.

Patient reports more dyspnea than usual, orthopnea, or unexplained fatigue that persists.Patient has signs of fluid retention with JVD or rales on chest auscultation.

ALGORITHM: DOWN-TITRATION

Criteria for decreasing dose of thiazide diuretic:

If the patient experiences dose-related complications unrelated to electrolyte imbalance which can beaddressed with Electrolyte Assessment Table.

In order to allow for up-titration of Vasodilator (ACE-I, ARB, Hz/ISDN) or BBL.

If the patient is clinically stable, maintain the current dose of thiazide diuretic until patient is euvolemic.

\

Step 1


Assess patients current SCrand BP

If labs are appropriate, startstage 1 thiazide. If patientalready on thiazide, increase by1 stage

Have patient monitor BP,

weight, signs and symptomsdaily

In addition to scheduledtelephone contact, tell patient tocall if symptoms worsen orweight continues to increase

Step 2

Day 4 (Telephone)

Patient to report BP, signs,symptoms and weight


Repeat Panel 7

Replace/monitor electrolytesper Electrolyte Assessment

Table

Step 3


If fluid retention has notimproved, go back to Step 1 ofup-titration

If fluid retention improving oreuvolemia achieved, maintaincurrent dose

Contact cardiologist if

persistent HF symptoms existwith up-titration


Repeat Panel 7

Replace/monitor electrolytesper Electrolyte AssessmentTable

Repeat Step 3 until satisfactoryvolume status has beenachieved

Step 1

Day 1 (Telephone)

If symptoms have resolved and

one of the above criteria aremet, discontinue thiazidediuretic

Repeat Panel 7 within 1 week

Step 2

Day 2-6 (Telephone)

If weight gain or symptoms

return, re-start increaseddose(s) and try to taper after 3days if fluid retention improves

If cannot d/c thiazide, discusswith cardiologist and considermaintaining patient on athiazide

Step 3


If there is no increase in weight

or symptoms, may repeat Step1 or continue current dose ifstable maintenance dose isattained by patient


21/48



DRUGINTERACTIONS

1. ACE-I and ARB medications may cause postural hypotension in patients with sodiumdepletion or hypovolemia due to diuretics or sodium restriction. This hypotensiveresponse is usually transient. Closely monitor BP.

2. Diuretic-induced hypokalemia may increase risk of digoxin toxicity3. NSAIDs, including COX-2 Inhibitors, may decrease the efficacy of thiazides4. Alcohol, barbiturates, or narcotics may potentiate orthostatic hypotension.

5. Corticosteroids may potentiate hypokalemia in patients taking diuretics.6. Thiazide therapy may increase cholesterol and triglyceride levels. If patient is oncholestyramine or colestipol, advise patient to take thiazide diuretics at least 1 hourbefore or 4-6 hours after these Bile-Acid Sequestrants.

7. Thiazides may increase lithium levels and lithium toxicity. Patients on lithium should bemonitored for alterations in their mental status. Consult with cardiologist if so noted.

FOR DOSE RELATED COMPLICATIONS BELOW: IF PATIENT ON ACE-I OR ARB, CHECK APPROPRIATESECTION OF PROTOCOL C OR D. IF PATIENT ON SPIRONOLACTONE, THEN CHECK PROTOCOL F.


1. Symptomatic hypotension: Volume depletion can occur as a result of excessivediuresisthereby leading to reduced BP and renal impairment. However, if the patient haspersistent fluid retention and is hypotensive with SBP < 90mmHg, this could be a sign ofworsening HFindicating a decline in peripheral perfusion.a. If suspect excessive diuresis:

i. Hold 3 days of thiazide dose and restart at 1 stage less than previous dose.ii. Encourage fluid intake for 3 days.iii. Reassess BP and any hypotensive symptoms within 3 days.iv. Repeat Panel 7 in 1 week.v. If symptoms of excessive diuresis persists, repeat steps 1-4 as above. If

symptoms resolve, continue new dose of furosemide as maintenance dose.b. If suspect worsening HF:

i. Consult with Medical Director or cardiologist.2. Prerenal Azotemia: HF patients are at a higher risk of developing this condition due to

poor perfusion of their kidneys as a result of a low CO. Exacerbation by diuretic useincreases the risk. After changing dose of thiazide diuretic, watch for sudden increases inBUN and SCr associated with symptoms of hypotension and decreased urine output. If

patient reports symptoms:a. Hold 3 days of thiazide dose and restart at 1 stage less than previous dose.b. Encourage fluid intake for 3 days.c. Reassess BP and hypotensive symptoms within 3 days.d. Repeat Panel 7 in 1 week.e. If prerenal azotemia persists, repeat steps 1-4 above. If symptoms resolve, continue

new dose of thiazide diuretic as maintenance dose.3. Electrolyte abnormalities: hypokalemia, hyponatremia, hypomagnesemia

a. Replace/monitor per Electrolyte Assessment Table.4. Hyperuricemia: Increased uric acid absorption can occur in the proximal tubules of the

kidneys, leading to higher serum concentrations. Hyperuricemia can develop within a fewdays after initiation of treatment and is dose dependent. Levels will not decrease withprolonged administration of thiazides.

a. If asymptomatic:i. Treatment is not necessary since increase in serum uric acid concentrations is

not usually clinically significant.b. If symptomatic:

i. May need to discontinue thiazide.ii. Consult with PCP to either initiate uricosuric therapy or allopurinol.


1. Refer to Laboratory Monitoring Schedule as described in Protocol A: Loop Diuretic.


22/48




HFCM PROGRAM

GOAL OFTHERAPY

To reduce the blood pressure in patients with HF, thereby reducing the workload of the heart.ACE inhibitors are the preferred first-line treatment in patients with HF.

MECHANISMOF ACTION

To inhibit angiotensin converting enzyme, interfering with conversion of angiotensin I toangiotensin II, causing vasodilatation and reduction in peripheral vascular resistance.Vasodilatation occurs in both the venous and arterial systems, reducing both preload andafterload, improving cardiac output without increasing heart rate.

DOSAGEFORMS

Fosinopril tablets: 10 mg, 20 mg, 40 mgLisinopril tablets: 2.5 mg, 5 mg, 10 mg, 20 mg, 30 mg, 40 mgBenazepril tablets: 5 mg, 10 mg, 20 mg, 40 mg

INCLUSIONCRITERIA

1. LVEF 40%2. Baseline SBP 90 mmHg without hypotensive symptoms. If patient has asymptomatic

SBP < 90mmHg, consult with cardiologist regarding initiation of ACE-I.

EXCLUSIONCRITERIA

1. Idiopathic or hereditary angioedema2. Bilateral renal artery stenosis or outflow tract obstruction3. Pregnancy or breast-feeding4. Inconsistent contraceptive use in women of child bearing age5. Well-documented intolerance of ACE-I due to symptomatic hypotension or cough.

Consider re-challenging patients with history of intolerance due to cough only, since coughmay be a manifestation of poorly compensated HF

6. Patients with SBP < 90 mmHg and symptoms of hypovolemia due to diuretic therapy.Reassess and consider when volume restoration occurs after appropriate furosemidedosage reduction.

7. Renal impairment as shown by sustained SCr 3.0 mg/dL (consult with Medical Directoror cardiologist)

8. Persistent elevations in serum potassium (K+> 5.5 mmol/L) for patients not using

potassium supplements (consult with Medical Director or cardiologist)

CAUTION 1. Start ACE-I at lower doses or monitor closely when initiating therapy in:a. Patients with SCr 2.5 mg/dL and/or CrCl< 60 mL/minb. Patients taking potassium supplements or potassium-sparing diuretics

c. Hyponatremic patients (history of hyponatremia)2. Caution patients about persistent dry cough (which may occur in up to 20% of patients),

symptoms of hypotension (lightheadedness, dizziness, fatigue, headache), and symptomsof angioedema (swelling of face, eyes, lips, tongue, larynx, mucous membranes, difficultyswallowing or breathing, hoarseness) when ACE-I drugs.

PROTOCOL C: ANGIOTENSIN CONVERTING ENZYME INHIBITOR (ACE-I)


23/48



ALGORITHM: INITIATION/TITRATION STAGES IN CONJUNCTION WITH BBL

ACE-I therapy achieves best results in conjunction with BBL therapy

(Refer to Vasodilator and BBL Titration Schematic)

Key Points

Start at the lowest dose and increase as tolerated until a maximum tolerated dose or target dose is reached (goal:every 2 weeks).

BBL may be metoprolol succinate or carvedilol.

Refer to Pharmaceutical Management Schematic for optimal titration.

Initiation and Titration

Start at half the Stage 1 dose if SBP 100 mmHg, serum Na+< 130 mmol/L, SCr > 2.4 mg/dL, or serum K

+> 5.0

mmol/L, and up-titrate proportionally.

Start at double the Stage 1 dose if BP > 140/90 mmHg, and up-titrate proportionally.

During dose titration, attempt to maintain the patients SBP > 90 mmHg although a lower SBP without symptomsof hypotension may be tolerated.

Discontinue potassium sparing diuretics (except spironolactone) if serum K+> 4.0 mmol/L.

Hold potassium supplements unless serum K+is < 4.5 mmol/L.If patient shows evidence of hypovolemia with corresponding rise in BUN/SCr, reassess candidacy for ACE-I andconsult with cardiologist.


24/48



ACE-I (Fosinopril or equivalent)

Pre-Initiation Check

Baseline labs (within past month): Panel 7

Stage 1

Day 1 - Clinic Laboratory Monitoring10 mg PO daily Panel 7 in 7-14 days

Day 3 - Telephone PRN MonitoringContinue initial dose If hypotension or HF

symptoms emerge, patientshould contact CareManager about adverseeffects of ACE I

Stage 2

Day 1 - Clinic Laboratory Monitoring

20 mg PO daily Panel 7 in 7-14 days

Day 3 - Telephone PRN MonitoringContinue Stage 2 dose Refer to Stage 1, Day 3

Stage 3 (Target)

Day 1 - Clinic Laboratory Monitoring40 mg PO daily Panel 7 in 7-14 days and

every 6 months thereafter



25/48



DRUGINTERACTIONS

1. ACE inhibitors may increase serum potassium if taken in conjunction with other drugs thatare known to increase serum potassium (spironolactone, amiloride, triamterene). Monitorserum potassium closely in these patients.

2. Patient use of additional antihypertensives could result in symptomatic hypotension. Allpatients should have medication reconciliation done at the time of entry into the HFCMProgram. Consult with cardiologist if there are any concerns about concurrent

medications.3. NSAIDs, due to increased risk of worsening renal function, increased fluid accumulation,and may lead to hyperkalemia

4. If patient is on antacids, separate dosing of ACE-I and antacids by 2 hours.5. ACE-Is may increase lithium levels and/or lithium toxicity. Patients on lithium should be

monitored for alterations in their mental status. Consult with cardiologist if so noted.

FOR DOSE RELATED COMPLICATIONS BELOW: IF PATIENT ON SPIRONOLACTONE, THEN CHECKPROTOCOL F.


1. Renal dysfunction:Elevations in SCr and BUN are usually small (< 0.4mg/dL and 4mg/dL, respectively) and most likely seen in the first 6 weeks of therapy. Renal functionmay improve within 2 weeks of ongoing therapy in up to 25% of patients. Renallyimpaired patients may not be able to tolerate large doses of ACE-I so consider usinglower doses.a. Confirm patient not taking NSAIDs .b. If SCr increases by 0.4 mg/dL, recheck SCrin 2 weeks. If no further increase,

maintain current dose of ACE-I.c. If SCr increases by 0.5-1.0 mg/dL, recheck SCr in 1 week. If SCr remains high, then

hold ACE-I and consult with cardiologist; diuretic dose may need to be decreased. Ifon laboratory recheck, the SCr elevation resolves (increase < 0.4mg/dL frombaseline), then resume ACE-I dose at half of previous dose. Recheck SCr in 1 weekfrom that point in time with the last SCr serving as new baseline.

d. If SCr > 4.0 mg/dL or is elevated by > 1.0 mg/dL from baseline, hold ACE-I andconsult with cardiologist. Consider using the combination of Hz/ISDN instead ofACE-I (refer to Protocol G: Hz/ISDN).

2. Hyperkalemia:Risk factors for hyperkalemia (K+> 5.5 mmol/L) include Diabetes Mellitus

and the elderly.a. If serum K

+elevated, recheck within 24 hours to confirm initial level.

b. If repeat K+> 5.5 mmol/L, discontinue dietary potassium sources (such as salt

substitutes, foods high in potassium), hold potassium supplements, and discontinuepotassium sparing diuretics. Order ECG and review with cardiologist. Recheckserum K

+in 48 hours.

c. If serum K+is not lowered, reduce ACE-I dose by 50%. Recheck serum K

+in 7 days.

d. If hyperkalemia resolves, tell the patient to continue taking the lower dose of theACE-I and check the serum K

+again in 1 week.

e. If hyperkalemia persists, hold the ACE-I and discuss with cardiologist. Considerusing the combination of Hz/ISDN instead of ACE-I (refer to Protocol G: Hz/ISDN).

3. Symptomatic hypotension:Patients with hyponatremia (Na+< 130 mmol/L), SCr > 1.7

mg/dL, or a recently modified diuretic dose are at increased risk of symptomatic

hypotension. Once the target dose of the ACE-I is reached, the average reductions frombaseline in SBP and DBP can be expected to range from 5-10 mmHg and 3-6 mmHg,respectively.a. If the BP is decreased by more than 10 mmHg or HR has increased over 10 bpm

from baseline, the patient may be dehydrated. If the patient does not have significantfluid retention, hold 2 diuretic doses and decrease diuretic dose by 1 stage to adjustfor changes induced by ACE-I therapy. Resume ACE-I dose titration when thepatient has achieved euvolemic status.

b. If the patient remains symptomatic, reduce the ACE-I dose to the previous tolerateddose.

c. Tell the patient to take the ACE-I dose at night or at different time from otherantihypertensive medications.


26/48



d. If taking the ACE-I once daily, divide dose to twice daily.e. Consider telling the patient to take the ACE-I with food in order to slow the rate of

absorption.f. If symptomatic hypotension recurs with each dose change despite above measures,

increase dose change intervals from 2 to 4 weeks.4. Persistent dry cough:Determine whether the patient is willing to tolerate the cough

associated with ACE-I therapy, since this drug belongs to a class of drugs that representfirst-line therapy for Systolic HF patients. Some studies have shown that cough resolvesby six months in up to 38-55% of patients, so patients should consider continuing ACE-Itherapy. Tell patients to consider taking OTC antitussives or lozenges while they wait forcough resolution.a. Check for signs or symptoms of pulmonary edema or asthma (wheezing). If found, or

uncertain of findings, consult with cardiologist.b. If other underlying causes are ruled out, discontinue ACE-I and replace with an ARB

(see Protocol D) if the cough is persistent and causes vomiting or interferes withdaily activities or sleep.

5. Angioedema:Symptoms include swelling of face, eyes, lips, throat, or tongue ordyspnea. This occurs in


27/48




HFCM PROGRAM

GOAL OFTHERAPY

To reduce the blood pressure in patients with HF, thereby reducing the workload of the heart.ACE inhibitors are the preferred first-line treatment in patients with HF, but due to theintolerance by some patients, an ARB may be substituted.

MECHANISMOF ACTION

Selectively antagonizes angiotensin II receptors (AT11000 times greater than AT2), promotingvasodilation and decreasing the effects of aldosterone.

DOSAGEFORMS

Losartan tablets: 25 mg, 50 mg, 100 mgValsartan tablets: 40 mg, 80 mg, 160 mg, 320 mg

INCLUSION 1. LVEF 40%CRITERIA 2. Unable to tolerate ACE-I due to cough or angioedema

3. Baseline SBP 90 mmHg without hypotensive symptoms

EXCLUSION 1. Prior hypersensitivity reaction to an ARBCRITERIA 2. Bilateral renal artery stenosis or outflow tract obstruction

3. Pregnancy or breast feeding4. Inconsistent contraceptive use in women of child bearing age5. Persistent elevations in serum potassium (K

+> 5.5 mmol/L) for patients not using

potassium supplements (consult with Medical Director or cardiologist)6. Patients with SBP < 90 mmHg and symptoms of hypovolemia due to diuretic therapy.

Reassess and consider when volume restoration occurs after appropriate fuorsemidedosage reduction.

CAUTION 1. Start ARB at lower doses or monitor closely when initiating therapy in:a. Patients with SCr 2.5 mg/dLand/or CrCl < 60 ml/minb. Patients taking potassium supplements or potassium-sparing diureticsc. Hyponatremic patients (history of hyponatremia)

2. Advise patients that first dose may cause symptoms of hypotension and be aware of thisreaction in subsequent up-titration

3. Caution patients about warning signs and symptoms of fluid and electrolyte imbalance:dry mouth, thirst, weakness, lethargy, drowsiness, restlessness, confusion, seizures,muscle pains or cramps, muscular fatigue, hypotension, oliguria, tachycardia, GIdisturbances such as nausea/vomiting

PROTOCOL D: ANGIOTENSIN II RECEPTOR BLOCKERS (ARBs)


28/48



ALGORITHM: INITIATION/TITRATION STAGES IN CONJUNCTION WITH BBL

ARB therapy achieves best results in conjunction with BBL therapy

(Refer to Vasodilator and BBL Schematic)

Key Points

Start at the lowest dose and increase as tolerated until a maximum tolerated dose or target dose is reached (goal:every 2 weeks).

BBL may be metoprolol succinate or carvedilol.

Refer to Pharmaceutical Management Schematic for optimal titration.


During dose titration, attempt to maintain the patients SBP > 90 mm Hg although a lower SBP without symptoms ofhypotension may be tolerated.

Discontinue potassium sparing diuretics (except spironolactone) if serum K+> 4.0 mmol/L.

Hold potassium supplements unless serum potassium < 4.5 mmol/L

If patient shows evidence of hypovolemia with corresponding rise in BUN/SCr, reassess candidacy for ARB.


29/48



ARB (Losartan or equivalent)


Baseline labs (within past month): Panel 7

Stage 1

Day 1 - Clinic Laboratory Monitoring25 mg PO daily Panel 7 in 7-14 days

Day 3 - Telephone PRN MonitoringContinue initial dose If hypotension or HF

symptoms emerge, patientshould contact CareManager about adverseeffects of ACE I

Stage 2


50 mg PO daily Panel 7 in 7-14 days


Stage 3 (Target)


100 mg PO daily Panel 7 in 7-14 days andevery 6 months thereafter



30/48



DRUGINTERACTIONS

1. ARBs may increase serum potassium if taken in conjunction with other drugs that areknown to increase serum potassium (spironolactone, amiloride, triamterene). Monitorserum potassium closely in these patients.

2. Patient use of additional antihypertensives could result in symptomatic hypotension. Allpatients should have medication reconciliation done at the time of entry into the HFCMProgram. Consult with cardiologist if there are any concerns about concurrent

medications.3. NSAIDs, due to increased risk of worsening renal function, increased fluid accumulation,and may lead to hyperkalemia

4. ARB medications may increase lithium levels and/or lithium toxicity. Patients on lithiumshould be monitored for alterations in mental status. Consult with cardiologist if so noted.

FOR DOSE RELATED COMPLICATIONS BELOW: IF PATIENT ON SPIRONOLACTONE, THEN CHECKPROTOCOL F.


1. Renal dysfunction:Elevations in SCr and BUN are usually small (< 0.4mg/dL and 4mg/dL, respectively) and most likely seen in the first six weeks of therapy. Renal functionmay improve within 2 weeks with ongoing therapy in up to 25% of patients. Renallyimpaired patients may not be able to tolerate large doses of an ARB so consider usinglower doses.a. Refer to management of renal dysfunction as described in Protocol C: ACE-I.

2. Hyperkalemia:May be seen in 2% of HF patients receiving optimal ARB therapy.a. Refer to management of hyperkalemia as described in Protocol C: ACE-I.

3. Symptomatic hypotension:Patients with hyponatremia (Na+< 130 mmol/L), SCr > 1.7

mg/dL, or a recently modified diuretic dose are at increased risk of symptomatichypotension. Once the target dose of the ARB is reached, the average reductions frombaseline in SBP and DBP can be expected to range from 5-10 mmHg and 3-6 mmHg,respectively.a. Refer to management of symptomatic hypotension as described in Protocol C:

ACE-I.4. Angioedema: Symptoms include swelling of face, eyes, lips, throat, or tongue or

dyspnea.a. Discontinue ARB immediately. If swelling is confined to face and lips, the condition

usually improves without treatment. Consult with cardiologist for treating the patientwith OTC antihistamines for symptom relief.

b. If the patient shows compromised breathing (due to tongue swelling, glottis, orlarynx), send to ED immediately for appropriate therapy.


1. Refer to Laboratory Monitoring Schedule as described in Protocol C: ACE-I.

Equivalent Daily Doses of ARB Medications for use in HF Patients

ARB Frequency

Initial

Dose Titration Titration Target

Maximum

Daily Doselosartan QD 25 mg 50 mg 100 mg 100 mg 100 mg

valsartan BID 40 mg 80 mg 160 mg 160 mg 320 mg

candesartan QD 4 mg 8 mg 16 mg 32 mg 32 mg


31/48




HFCM PROGRAM

GOAL OFTHERAPY

To improve improve long-term symptoms, improve LVEF and reduce remodeling of the heartstructure itself, especially in patients s/p Acute Myocardial Infarction (AMI) with provensignificant reduction in mortality.

MECHANISMOF ACTION

The mechanism of action is similar between the BBLs. Carvedilol is a nonselective beta-adrenergic blocking agent with alpha-adrenergic blocking properties. Metoprolol succinate is aBBL with selective activity on beta-1 adrenoreceptors located mainly in cardiac muscles, withlittle or no effect on beta-2 receptors at doses < 100 mg. Effects of BBLs include reduction ofCO, HR, decreased systemic and peripheral vascular resistance, and reduced plasma reninactivity.

DOSAGEFORMS

Carvedilol tablets: 3.125 mg, 6.25 mg, 12.5 mg, 25 mgMetoprolol succinate tablets: 25 mg, 50 mg, 100 mgBisoprolol tablets: 5 mg, 10 mg

INCLUSIONCRITERIA

1. LVEF 40%2. No signs of fluid retention3. Currently on therapy with ACE I or other vasodilators, and diuretics4. Baseline heart rate of 55 bpm 5. Baseline SBP of 90 mmHg without hypotensive symptoms; if patient has asymptomatic

SBP < 90mmHg, consult with cardiologist before initiation

EXCLUSION

CRITERIA

1. Heart rate < 55 bpm (consult with cardiologist)

2. History of heart block > 1stdegree3. History of severe or poorly controlled asthma (consult with cardiologist)4. History of hypersensitivity to any BBL5. Volume depletion (consider reducing diuretics and reassess for BBL therapy when

euvolemic)6. Acute HF decompensation and patient not yet stabilized with resolution of symptoms

CAUTION 1. First degree heart block with PR interval > 0.30 seconds2. Severe hepatic impairment (ALT/AST > 3 times upper limit of normal)3. Severe claudication4. Patient has poorly controlled Diabetes Mellitus with documented episodes of

hyperglycemia and hypoglycemia5. Discuss signs and symptoms of hypotension; risk of alterations in blood glucose,

especially if known diabetic or risk factors for Diabetes Mellitus; risk of CNS symptoms(nightmares, depression, fatigue), and avoidance of sudden discontinuation of carvedilol ormetoprolol succinate.

6. Discuss with patient to avoid abrupt changes in position since postural hypotension mayoccur as doses are titrated up

PROTOCOL E: BETA BLOCKERS (BBL)


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ALGORITHM: INITIATION/TITRATION STAGES IN CONJUNCTION WITH VASODILATOR

Key Points

A minimum of 2 weeks is required between dose increases of BBL

Up-titration times are variable (can take up to 4 months) and may require adjustment of other medications

The patients BP, HR, and symptoms will determine the up-titration schedule

If the patients SBP is between 90-100 mmHg, consider initially decreasing the doses of other vasodilators whenstarting a BBL; upon stabilization with BBL dose, increase doses of other vasodilators to previous doses

Prevention of symptomatic hypotension and avoidance of acute exacerbation of HFo If symptomatic hypotension occurs, stagger doses of HF medications 2-3 hours aparto Once the patient has stabilized on a target BBL dose, co-administration of HF medications should be safeo Take BBL with food to minimize symptomatic hypotensiono Do not abruptly discontinue BBL; taper over a 2 week period


Patients are eligible for titration over the telephone if all of the following criteria are met:

Patient or caregiver willing and able to check and accurately report BP, HR, weight, and HF symptoms over phone

Patient must demonstrate good compliance with all treatment and has not missed any appointmentsPatient must be able to come in to be examined when and if required

Patient does not display any hypotensive symptoms at the time of titration

BBL therapy achieves best results in conjunction with Vasodilator therapy

(Refer to Vasodilator and BBL Schematic)


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BBL (Carvedilol or equivalent)


Baseline Labs (within past month): Panel 7ECG (within past 3 months): if not done, order one and review with cardiologist prior to initiation

HR > 60 bpm and SBP > 90 mmHgWeight (to determine target dose of carvedilol)

Stage 1

Day 1 - Clinic Monitoring3.125 mg PO BID Call the patient and ask

about symptoms of

intolerance or doserelated complications. Ifnot tolerated after 2weeks, continue currentdose and reassess at 4weeks.

Day 3 - Telephone PRNContinue initial dose

Stage 2

Day 1 - Clinic Monitoring6.25 mg PO BID Refer to Stage 1

Day 3 - Telephone PRNContinue Stage 2 dose

Stage 3

Day 1 - Clinic Monitoring12.5 mg PO BID Refer to Stage 1

Day 3 - Telephone PRNContinue Stage 3 dose

Stage 4 (Target)

Day 1 - Clinic Laboratory monitoring25 mg PO BID Panel 7 in 14 days and

every 6 months thereafter.

Day 3 - Telephone PRN MonitoringContinue Stage 4 dose Refer to Stage 1

Note: if 85 kg, target dose is 50 mg PO BID (Stage5 required)


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DRUG CarvedilolINTERACTIONS 1. Carvedilol can increase the risk of toxicity of digoxin and cyclosporine.

2. Concomitant use of digoxin/amiodarone/verapamil/diltiazem can potentiate bradycardiaand/or slow AV conduction.

3. Potent CYP2D6 inhibitors can increase toxicity of carvedilol. Potent inhibitors includeSSRIs, bupropion, thioridazine, quinidine, propafenone, ritonavir, hydroxychloroquine,

terbinafine, and cimetidine..4. If clonidine therapy is to be discontinued, carvedilol should be gradually discontinuedseveral days before clonidine is withdrawn due to risk of rebound hypertension.

5. Rifampin can decrease plasma concentrations of carvedilol.6. Carvedilol can mask hypoglycemic symptoms.

Metoprolol Succinate1. Concomitant use of digoxin/amiodarone/verapamil/diltiazem can potentiate bradycardia

and slow AV conduction.2. Potent CYP2D6 inhibitors can increase toxicity of metoprolol succinate. Potent inhibitors

include SSRIs, bupropion, thioridazine, quinidine, propafenone, ritonavir,hydroxychloroquine, terbinafine, and cimetidine.

3. If clonidine therapy is to be discontinued, metoprolol succinate should be graduallydiscontinued several days before clonidine is withdrawn due to risk of reboundhypertension.

4. Rifampin can decrease plasma concentrations of metoprolol succinate.5. Metoprolol succinate can mask hypoglycemic symptoms.


1. Worsening HF:Signs and symptoms of worsening HF may present as persistent fatigue,edema, weight gain, or dyspnea.a. Lengthen the intervals for up-titration from 2 weeks to 4 weeks.b. Increase diuretic dosing (and K

+according to Protocol A) by one stage.

c. Lower the BBL dose to the previous dose if significant symptoms persist that thepatient reports he/she is unable to tolerate.

2. Symptomatic hypotension:Advise patients to avoid abrupt changes in position.a. Lengthen the intervals for up-titration from 2 weeks to 4 weeks

b. Advise patients to take BBL before bedtimec. Lower the dose of vasodilators by one stage if symptoms persist 72 hours after

above changes. If symptoms persist with this initial vasodilator dose reduction,further lower diuretics by one stage. 72 hours later, if symptoms are persistent, go tostep d.

d. Decrease BBL dose to prior dose if significant symptoms persist.e. Within two weeks, can increase dose of vasodilators to prior dose after patient

is clinically stable on dose of BBL.3. Bradycardia (HR < 55 bpm)

a. Obtain ECG and review with cardiologist.b. If patient is taking digoxin, hold digoxin and repeat ECG in 7 days. After review with

cardiologist, restart or continue to hold digoxin per cardiologist decision.c. Discuss with cardiologist reduction of BBL dose by one stage. Repeat ECG in 7 days

and review with cardiologist.d. If heart rate < 50 bpm is persistent after initial dose reduction by one stage or the

patient remains symptomatic, taper off BBL and repeat ECG in 7 days and consultwith cardiologist regarding further dose management.

4. Asthma/bronchospasm (wheezing)a. Consult with cardiologist if patient reports wheezing; assess for bronchial vs. cardiac

asthma. Look for evidence of fluid retention to indicate presence of cardiac asthma.b. If bronchial asthma, refer to patients PCP to optimize asthma medications. Taper off

carvedilol. Switch to equivalent dose of metoprolol succinate.c. If patient is judged to be intolerant of carvedilol or metoprolol succinate, based on

persistent symptoms of asthma/bronchospasm, consult cardiologist and document inchart.


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d. Once asthma is under control with improved asthma or bronchospasm therapy perPCP, consult with cardiologist regarding reinitiation of a BBL.

5. Hepatitis (right upper quadrant pain)a. Check LFTs if patient complains of persistent RUQ pain or presents with other

symptoms suggestive of hepatitis.b. Review results with cardiologist and develop a plan of care.

c. If results are significant, taper or discontinue BBL; monitor for response and re-evaluate in consultation with cardiologist.6. Fatigue: Fatigue may occur for any number of underlying reasons in patients with Heart

Failure. If mild, maintain current dose of medication and monitor patient for 2 weeks.Check Panel 7. Consult with cardiologist for evaluation of other causes (see below). Ifsignificant symptoms persist after 2 weeks, taper or decrease dose of BBL by one stage.Monitor for response and reevaluate.a. If fatigue is due to volume depletion:

i. Encourage fluid intake.ii. Hold one diuretic dose and decrease diuretic dose by one stage; counsel

patients to avoid sudden postural changes; reassess vital signs andhypotensive symptoms within 3 days.

iii. If symptoms persist, reduce vasodilator dose per Protocol; reassess vital signsand hypotensive symptoms within 3 days. If symptoms resolve, increasevasodilator dose by 50% of dose reduction with splitting of dose evenlybetween morning and evening dose.

iv. If symptoms persist after taking above measures, consult with cardiologist.v. If SBP < 90 mmHg, consult with cardiologist.

b. If fatigue is due to confirmed hyperkalemia:i. Discontinue any dietary potassium source, potassium supplements and all

potassium sparing diuretics except spironolactone; if on spironolactone 25mg/day, lower to 12.5 mg PO daily; if on spironolactone 12.5 mg/day,discontinue; repeat serum K

+in 48 hours

ii. If potassium level does not decrease, lower ACE-I/ARB dosage by 25%; repeatK

+level in one week.

iii. If hyperkalemia resolves, continue current dose and repeat K+level in one

week.

iv. If hyperkalemia persists, hold ACE-I/ARB and consult with cardiologist;consider Hz/ISDN instead of ACE-I/ARB.

c. If fatigue is due to digoxin:i. If accompanied by associated symptoms such as confusion, N/V/D, unusual

weakness/tiredness, drowsiness, HA, loss of appetite, palpitations or visualdisturbances (blurred or yellow vision, halo effect), hold digoxin and checkECG, digoxin level, Panel 7, Mg

2+, and Ca

2+.

ii. If digoxin level > 2.5 ng/mL, contact cardiologist immediately. Follow ProtocolH: Digoxin.

d. Other causes of fatigue may include anemia, diabetes, hypothyroidism, infections,psychologic conditions. Consult with cardiologist as needed for further evaluation.

7. Increased agitation/insomniai. If mild, continue current dose of BBL and monitor for 2 weeks. Consult with

cardiologist for evaluation of other causes.ii. If significant symptoms persist, decrease dose of BBL by one stage; monitor for

response and re-evaluate after 2 weeks. Consult with cardiologist regarding furtherdose changes.

8. GI disturbancesi. If mild, continue current dose of BBL and monitor for 2 weeks. Consult with

cardiologist for evaluation of other causes.ii. If significant symptoms persist, decrease dose of BBL by one stage; monitor for

response and re-evaluate after 2 weeks. Consult with cardiologist regarding furtherdose changes.


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1. Baseline laboratory testing for BBL therapy shall consist of a Panel 7 and digoxin level (ifapplicable). Check these labs if not done within the past month.

2. A Panel 7 should be obtained after titration of BBL to the maximum tolerated dose.3. After titration of medication and the patient is on stable regimen, a Panel 7 should be

obtained at least every 6 months while the patient is enrolled in the HFCM Program.

Equivalent Daily Doses of BBLs for use in HF Patients(bolded BBLs have proven M/M benefit)

BBL FrequencyInitialDose

Titration Titration TargetMaximumDaily Dose

carvedilol BID 3.125 mg 6.25 mg 12.5 mg25 mg (


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HFCM PROGRAM

GOAL OFTHERAPY

As an adjunctive medication, to provide additional potassium sparing diuresis and potentiallyreverse or prevent progression of the adverse effects of aldosterone on the structure andfunction of the heart, with proven significant reduction in mortality.

MECHANISMOF ACTION

To inhibit the effect of aldosterone by competing for the aldosterone-dependent sodium-potassium exchange site in the distal tubule cells of the kidneys, resulting in sodium chlorideand water excretion while conserving potassium and hydrogen ions.

DOSAGEFORMS

Spironolactone tablets: 25 mg, 50 mg, 100 mg

INCLUSIONCRITERIA

1. NYHA Class III-IV HF and LVEF 35% or s/p AMI with LVEF 40% and signs/symptomsof HF

EXCLUSIONCRITERIA

1. Hypersensitivity to spironolactone2. Persistently elevated SCr >2.5 mg/dL3. Persistently elevated serum potassium ( > 5.0 mmol/L) despite being off potassium

supplements4. Patients unable to adhere to laboratory testing schedule

CAUTION 1. Patients currently taking daily doses of potassium exceeding 120 mEq/day

2. Patients with borderline hyponatremia or history of hyponatremia3. Given higher risk of electrolyte abnormalities in patients taking spironolactone, discuss

signs of hyperkalemia (paresthesia, muscle weakness, fatigue, bradycardia, and shock)with the patient, along with discussing signs of dilutional hyponatremia (dry mouth, thirst,lethargy, and drowsiness).

4. Tell male patients to watch for signs of gynecomastia (breast enlargement).5. Stress the importance of NOT missing laboratory tests that are scheduled for the patient

per protocol. Spironolactone will be discontinued or the refill will not be approved if thepatient misses lab testing.

6. Patients with HF should not take NSAIDs due to increased risk of worsening renalfunction, increased fluid accumulation, and possibly hyperkalemia

PROTOCOL F: ALDOSTERONE ANTAGONIST


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ALGORITHM: INITIATION/TITRATIONNote: in i t ia l ly prescr ibe on ly one w eek su pply;

i f the patient obtains the Panel 7 in 7 days as directed and the results are within n orm al l imits and no

into lerance or dos e re lated com pl icat ions are reported, then a one mo nth p rescr ip t ion m ay be wr i t ten


Baseline labs (within past month): Panel 7If taking potassium supplements > 60 mEq/day, continue dose if serum K

+< 4.3 mmol/L;

cut dosing by 50% if serum K+4.3-5.0 mmol/L

Stop potassium supplements if < 60 mEq/day

Spironolactone

STOP spironolactone and consult cardiologist if patient develops:

Signs and symptoms of gastroenteritis with N/V/DReason to suspect sodium or water depletion

BUN increases by 50% from baselineSCr increases by 25% from baseline

Serum K+exceeds 5.5 mmol/L

Stage 1

D

Documents

Heart Failure Care Manager Program Protocol