CONCORD INTERNAL & PULMONARY MEDICINE CONGESTIVE HEART FAILURE PROTOCOL. Douglas G. Kelling, Jr., MD & C. Gismondi-Eagan, MD, FACP

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CONCORD INTERNAL & PULMONARY MEDICINE CONGESTIVE HEART FAILURE PROTOCOL Douglas G. Kelling, Jr., MD & C. Gismondi-Eagan, MD, FACP Revised August 14, 2009

Page 1 Congestive Heart Failure Protocol Patients present in 1 of 3 ways 1. Syndrome of decreased exercise tolerance. 2. Syndrome of fluid retention. 3. Incidentally discovered left ventricular dysfunction. History Physical Exam CXR EKG LVEF measured by 2D Echo of the heart and/or Rest MUGA and/or Cardiac Cath (Use highest LVEF measured) U/A CBC CMP Stress Test to rule out CAD TSH Reflex Calculated GFR Spot urine for A/C ratio Treat lipid disorder Encourage smoking cessation Encourage regular exercise Discourage alcohol intake, illicit drug use LVEF < 40% (See Page 2) LVEF > 40% (See Page 23)

Page 2 Congestive Heart Failure Left Ventricular Systolic Dysfunction LVEF < 40 Ischemic cardiomyopathy? NYHA Class I (See Page 3) NYHA Class II, III, & IV (See Page 3) Repeat Echo in 3 months ACEI (See Page 8) or ARB (See Page 13) and Beta-Blocker (See Page 15) LVEF < 35 ACEI (See Page 8) Or ARB (See Page 13) and Aldosterone Antagonists (See Page 21) Beta-Blocker (See Page 15) Digitalis (See Page 7) Diuretic (See Page 4) Dietary Salt Restriction (Less than 3000mg sodium per day) Is patient African American LVEF < 40 LVEF > 40 further evaluation Continue present treatment. Assess volume status on all visits. Ischemic cardiomyopathy? Begin Bidil or Hydralazine and Nitrate (See Page 18) Consider Bidil or Hydralazine and Nitrate if clinically indicated (See Page 18) Patient on chronic optimal medical therapy Refer to cardiology LVEF < 35 Continue present treatment. Assess volume status on all visits.

Page 3 A Comparison of Two Methods of Assessing Cardiovascular Disability Class I II III IV New York Heart Association Functional Classification Patients with cardiac disease but without resulting limitations of physical activity. Ordinary physical activity does not cause undue fatigue, dyspnea, or palpitation. Patients with cardiac disease resulting in slight limitation of physical activity. They are comfortable at rest. Ordinary physical activity results in fatigue, dyspnea, or palpitation. Patients with cardiac disease resulting in marked limitations of physical activity. They are comfortable at rest. Less than ordinary physical activity causes fatigue, dyspnea, or palpitation. Patients with cardiac disease resulting in inability to carry on any physical activity without discomfort. Symptoms of cardiac insufficiency may be present even at rest. If any physical activity is undertaken, discomfort is increased. Specific Activity Scale Patients can perform to completion any activity requiring <7 metabolic equivalents: eg, can carry 24 lb up eight steps; carry objects that weigh 80 lb; do outdoor work (shovel snow, spade soil); do recreational activities (skiing, basketball, squash, handball, jog/walk 5 mph). Patients can perform to completion any activity requiring <5 metabolic equivalents: eg, have sexual intercourse without stopping, garden, rake, weed, roller skate, dance fox trot, walk at 4 mph on level ground, but cannot and do not perform to completion activities requiring >7 metabolic equivalents. Patients can perform to completion any activity requiring <2 metabolic equivalents: eg, shower without stopping, strip and make bed, clean windows, walk 2.5 mph, bowl, play golf, dress without stopping, but cannot and do not perform to completion any activities requiring >5 metabolic equivalents. Patients cannot or do not perform to completion activities requiring >2 metabolic equivalents. Cannot carry out activities listed above (Specific Activity Scale, Class III). Adapted from Goldman L, Hashimoto B, Cook ER, Loscalzo A. Comparative reproducibility and validity of systems for assessing cardiovascular functional class: advantages of a new specific activity scale. Circulation. 1981:64;1227. Reprinted with permission of the publisher, Lippincott, Williams & Wilkins.

Page 4 Diuretic Therapy Class II - IV CHF Assess volume status on all visits Symptoms and/or signs of volume overload: Symptoms: Dyspnea on exertion or rest; PVD; orthopnea; weight gain; abdominal bloating; decreased appetite; lower extremity swelling Signs or symptoms of volume overload Signs: Rales; JVP elevation; positive abdominal-jugular reflex; S 3 ; sacral or extremity edema Initiate or intensify sodium restriction. Consider fluid restriction < 2 liters/24 hr. especially if serum sodium < 130 mg/l. Discontinue NSAIDS or COX-2 inhibitors if patient on either or both Is patient on loop diuretic such as Lasix? Euvolemic Maintain sodium restriction. If on diuretic maintain at current dose. Symptoms: Dizziness/light headedness Hypovolemic Signs: Flat neck veins; symptomatic hypotension, elevated pulse rate, dry mucus membranes. Is patient on maximum dose of Lasix? (80 mg po tid) Begin Lasix 20-40 mg/day Reduce dose or discontinue diuretic temporarily. Consider loosening the degree of dietary sodium restriction Re-evaluate patient in 2-3 days See Page 6 Increase dose and/or frequency of diuretic by 50-100% See Page 5

Page 5 Re-evaluate patient in 1 week or as clinically indicated Symptoms and/or signs back to baseline Symptoms and/or signs not back to baseline Identifiable causes for symptoms/signs CHF e.g. nonadherence identifiable causes for symptoms/signs CHF Resume original dose diuretic Continue increased dose diuretic Increase diuretic by 50-100% up to a maximum dose of Lasix of 80 mg po tid Symptoms/signs back to baseline Persistent or worsening symptoms/signs at maximum dose of Lasix Improvement of symptoms/signs but not back to baseline See Page 4 See Page 6

Page 6 Begin metolazone 2.5 mg po Give 30-60 mm before dose loop diuretic Reassess patient in 3 days BMP and magnesium in 3 days Signs/symptoms back to baseline Signs/symptoms not back to baseline Stop metolazone Increase po metolazone to 5 mg/day See Page 4 Reassess patient in 3 days BMP and magnesium in 3 days Signs/symptoms back to baseline Consider admitting patient to the hospital for IV loop diuretic Discharge from hospital See Page 4

Page 7 Digoxin Dosage Patient elderly and/or Patient small in stature and/or Creatinine Clearance < 90 Begin 0.125 mg po Begin 0.25 mg po Measure digoxin level in 2-3 weeks Measure level > 6 hours after last dose of digoxin Adjust digoxin to serum level of 0.8 mg/ml or less Do not give more than 0.25 of digoxin a day Remeasure digoxin level if: 1. There is significant change in renal function. 2. Potentially interacting drug (Amiodarone, Quinidine or Verapamil) is added or discontinued. 3. Suspected digoxin toxicity based on signs/symptoms and/or EKG changes.

Page 8 Angiotensin Converting Enzyme Inhibition (ACEI) Treatment in Left Ventricular Systolic Dysfunction (LVEF < 40%) Optimize and stabilize diuretic treatment before beginning ACEI therapy Intractable cough with ACEI Do not use ACEI. Consider treatment with angiotensin receptor blocker (ARB) Angioedema with ACEI, bilateral renal artery stenosis and/or pregnancy Measure BMP K + < 5.5 K + > 5.5 Measure BMP See Page 13 K + >5.5mEq/L Serum sodium < 130mEq/L Or Creatinine > 1.7 ACEI and ARB are contraindicated K + 5.0 5.5 meq/l K + <5.0mEq/L Go to Page 9 Go to Page 11

Page 9 Initial Low Dose ACE Inhibitor (ACEI) Therapy Measure supine and standing blood pressure (BP) Systolic BP < 90 supine and/or standing Systolic BP > 90 supine and standing Do not begin ACEI Reevaluate patient in 2 weeks Begin low dose ACEI (See Page 10 for initial dosing of ACEI) Reevaluate patient if creatinine rises > 0.5 mg/dl from baseline and/or K + > 5.0 Cough on ACEI Measure BMP in 1 week Reevaluate patient in 2 weeks Use ARB (See Page 13) Systolic BP < 90 supine and/or standing Hold diuretic Reevaluate patient in 2-3 days Double dose of ACEI Every 2 wks (See Page 10) Target dose ACEI attained (See Page 10)

Page 10 ACE Inhibitors Low Initial Dose Captopril (Capoten) Enalapril (Vasotec) Lisinopril (Zestril/Prinivil) Quinapril (Accupril) Fosinopril (Monopril) Trandolapril (Mavik) Ramipril (Altace) 6.25mg tid 1.25mg BID 2.5mg 2.5mg po BID 5mg 1mg 1.25mg Reevaluate Patient 12.5mg tid 2.5mg BID 5mg 5mg po BID 10mg 2mg 2.5mg Reevaluate Patient 25mg tid 5mg BID 10mg 10mg po BID 20mg 4mg 2.5mg BID Reevaluate Patient 50mg tid 10mg BID 20mg 20mg po BID 40 mg 8 mg 5mg BID Maximum Dose 150mg tid 20mg BID 40mg 40mg po BID 40mg 8mg 10mg BID Reevaluate patient as clinically indicated

Page 11 Initial Standard Dose ACE inhibitor (ACEI) Therapy Measure supine and standing blood pressure (BP) Systolic BP < 90 supine and/or standing Systolic BP > 90 supine and/or standing Do not begin ACEI Re-evaluate patient in 2 weeks Begin standard dose ACEI (See Page 12 for initial dosing of ACEI) Reevaluate patient if creatinine rises > 0.5 mg/dl from baseline or K + > 5.0 Measure BMP in 1 week Reevaluate patient in 2 weeks Cough on ACEI Systolic BP < 90 supine and/or standing Use ARB (See Page 11) Hold diuretic Double dose of ACEI Every 2 weeks (See Page 12) Reevaluate patient in 2-3 days Target dose ACEI attained (See Page 12)

Page 12 ACE Inhibitors Standard Initial Dose Captopril (Capoten) Enalapril (Vasotec) Lisinopril (Zestril/Prinivil) Quinapril (Accupril) Fosinopril (Monopril) Trandolapril (Mavik) Ramipril (Altace) 12.5mg tid 2.5mg BID 5mg 5mg po BID 10mg 2mg 2.5mg Reevaluate Patient 25mg tid 5mg BID 10mg 10mg BID 20mg 4mg 2.5mg BID Reevaluate Patient 50mg tid 10mg BID 20mg 20mg po BID 40 mg 8 mg 5mg BID Maximum Dose 150mg tid 20mg BID 40mg 40mg po BID 40mg 8mg 10mg BID Reevaluate patient as clinically indicated

Page 13 Angiotensin Receptor Blocker (ARB) Therapy Measure supine and standing blood pressure (BP) Systolic BP < 90 supine and/or standing Systolic BP > 90 supine and/or standing Do not begin ACEI Re-evaluate patient in 2 weeks Begin initial dose ARB (See Page 14) Reevaluate patient if creatinine rises > 0.5mg/dl from baseline or K > 5.0 Measure BMP in 1 week Reevaluate patient in 2 weeks Systolic BP < 90 supine and/or standing Hold diuretic Double dose of ARB Re-evaluate patient in 2-3 days Target dose ARB attained (See Page 14)

Page 14 Angiotensin Receptor Blockers (ARB) Candesartan (Atacand) Irbesartan (Avapro) Losartan (Cozaar) Valsartan (Diovan) Telmisartan (Micardis) Eprosartan (Teveten) Olmesartan (Benicar) 4mg day 150mg 25mg BID 40mg BID 40mg 400mg, ½ tablet BID for two weeks 20mg for two weeks Reevaluate Patient in 2 weeks 8mg 300mg 50mg BID 80 mg BID 80mg 400mg BID 40mg Reevaluate Patient in 2 weeks 16g 300mg 50mg BID 80 mg BID 80mg 400mg BID 40mg Reevaluate Patient in 2 weeks 32mg 300mg 50mg BID 160 mg BID 80mg 400mg BID 40mg Reevaluate patient as clinically indicated

Page 15 BETA-Blocker Therapy Does patient have evidence of active asthma with bronchospasm and/or Sick sinus syndrome without pacemaker and/or Partial or complete atrial ventricular block and/or Heart rate < 60 or systolic BP supine or standing < 90 Do not give Beta- Blocker Unstable or decompensated heart failure Treat with diuretic until patient euvolemic and cardiovascular status stable Begin Beta-Blocker (See Page 17)

Page 16 BETA-Blocker Therapy Patient treated with ACE inhibitors (if tolerated), diuretic and digoxin for at least a month Patient clinically stable for two to three weeks NO other contraindications to Beta-Blocker (See Page 15) Heart Range > 60 And Systolic Blood Pressure supine and standing >90 Re-evaluate patient in two weeks Begin Beta Blocker at starting dose (See Page 15) Re-evaluate patient in two weeks Increased fatigue and/or lower exercise tolerance and/or weight gain Hypotension Systolic BP < 90 Bradycardia HR < 50 Patient Stable Consider increasing diuretic, keep B-Blocker at same dose if possible Hold diuretic 2 days then resume diuretic at ½ the original dose Decrease Beta-Blocker By 50% BMP 1 week after restarting diuretic Increase Beta-Blocker per protocol Target dose Beta-Blocker attained

Metoprolol Toprol XL Page 17 B-Blocker Therapy Carvedilol Coreg Bisoprolol Zebeta 12.5 mg 3.125 mg BID 1.25 mg Reevaluate patient 25 mg 6.25 mg BID 2.5mg Reevaluate patient 50 mg 12.5 mg BID 3.75 mg Reevaluate patient 100 mg 25 mg BID 5 mg Reevaluate patient 150 mg For patients weighing >85 kg, 50 mg BID may be used for 2 weeks 7.5 mg Reevaluate patient 200 mg 10 mg

Page 18 Bidil or Hydralazine (Apresoline) and Nitrates Therapy Measure supine and standing blood pressure (BP) Systolic BP < 90 supine and/or standing Systolic BP > 90 supine and standing Do not begin Hydralazine/Nitrates Reevaluate patient in 2 weeks Begin Bidil (See Page 20) or Hydralazine/Nitrates (See Page 19)

Page 19 Hydralazine/Nitrates Therapy Initial Doses Apresoline 37.5 mg po tid Isosorbide dinitrate 20mg tid Reevaluate patient in 4 weeks Systolic BP < 90 supine and/or standing Hold diuretic 2 days then resume diuretic at ½ the original dose Increase Apresoline to 75 mg po tid and Isosorbide dinitrate to 40 mg tid Reevaluate patient as clinically indicated

Page 20 Bidil Initial Dose Bidil one tablet po tid Reevaluate patient in 4 weeks Systolic BP < supine and/or standing Hold diuretic 2 days then resume diuretic at ½ the original dose Increase Bidil to two tablets tid Reevaluate patient as clinically indicated

Page 21 Aldosterone Antagonists Serum K+ > 5.0 meq/l or Creatinine >2.5 mg/dl (male); > 2.0 mg/dl (female) Or Estimated Creatinine clearance < 30 ml/min Or Close monitoring of patient cannot be insured Do not give Spironolactone Potassium supplements should be discontinued or reduced NSAIDS and COX-2 inhibitors should be avoided Begin Spironolactone 12.5 mg po Begin low potassium diet Measure BMP level in 3 days, 1 week and 1 month K > 5.0 K < 5.0 Discontinue Spironolactone Re-evaluate patient in 1 month Are there side effects of gynecomastia, breast pain, menstrual irregularis or decreased libido? (Endocrine side effects) Stop Spironolactone, begin Eplerenone Increase Spironolactone to 25 mg po See Page 22 Measure potassium level 3 days, 1 week and 1 month Then every 3 months Make sure patient not on potassium supplements, NSAIDS or COX-2 inhibitors Hold Spironolactone until K t < 5.0 then decrease Spironolactone to 12.5 mg po K t > 5.0 K < 5.0 Continue present dose Spironolactone Measure potassium level 1 week and 1 month Then every 3 months K > 5.0 K < 5.0 Discontinue Spironolactone Continue present dose Spironolactone Continue evaluation for endocrine side effects Endocrine side effects develop Endocrine side effects

Page 22 Aldosterone Antagonists Begin Eplerenone 25 mg po Potassium supplements should be discontinued or reduced Measure potassium level in 3 days, 1 week and 1 month Begin low potassium diet NSAIDS and COX-2 inhibitors should be avoided K > 5.0 K < 5.0 Discontinue Eplerenone Re-evaluate patient in 1 month Increase Eplerenone to 50 mg po Measure potassium level in 3 days, 1 week and 1 month and every 3 months K > 5.0 K < 5.0 Make sure patient not on potassium supplements, NSAIDS or COX-2 inhibitors Hold Eplerenone until K t is < 5.0 decrease Eplerenone to 25 mg po Measure potassium level in 3 days, 1 week and 1 month Continue present dose Eplerenone Measure K t level in 3 months K > 5.0 K < 5.0 Patient on potassium supplement, NSAID or COX-2 inhibitor Continue present dose Eplerenone Discontinue potassium supplements, NSAIDS or COX-2 inhibitors Discontinue Eplerenone Measure K t level in 3 months Hold Eplerenone until K t is < 5.0 Resume Eplerenone 25 mg

Page 23 Congestive Heart Failure Left Ventricular Diastolic Dysfunction LVEF > 40 Pulmonary congestion and/or Peripheral Edema Hypertension Atrial Fibrillation Decrease Exercise Tolerance Diuretic (See Page 4) See Hypertension Protocol Able to restore to normal sinus rhythm Digoxin (See Page 5) Consider antiarrhythmic agent to prevent recurrent Atrial Fibrillation Control ventricular rate Contraindication to Coumadin Coumadin Per protocol ECASA 81mg, one a day if no contraindication c:\forms\chf protocol