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## Complete Summary

#### GUIDELINE TITLE

Heart failure in patients with left ventricular systolic dysfunction:
HFSA 2006 comprehensive heart failure practice guideline.

#### BIBLIOGRAPHIC SOURCE(S)

Heart Failure Society of America. Heart failure in patients with left
ventricular systolic dysfunction. J Card Fail 2006 Feb;12(1):e38-57.
\[120 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16500571)

#### GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: Heart Failure Society of
America. Heart Failure Society of America (HFSA) practice guidelines.
HFSA guidelines for management of patients with heart failure caused by
left ventricular systolic dysfunction\--pharmacological approaches. J
Card Fail 1999 Dec;5(4):357-82.

### \*\* REGULATORY ALERT \*\*

#### FDA WARNING/REGULATORY ALERT

**Note from the National Guideline Clearinghouse**: This guideline
references a drug(s) for which important revised regulatory and/or
warning information has been released.

-   [August 16, 2007, Coumadin
    (Warfarin)](http://www.fda.gov/medwatch/safety/2007/safety07.htm#Warfarin):
    Updates to the labeling for Coumadin to include pharmacogenomics
    information to explain that people\'s genetic makeup may influence
    how they respond to the drug.

-   [October 6, 2006, Coumadin (warfarin
    sodium)](http://www.fda.gov/medwatch/safety/2006/safety06.htm#Coumadin):
    Revisions to the labeling for Coumadin to include a new patient
    Medication Guide as well as a reorganization and highlighting of the
    current safety information to better inform providers and patients.

### COMPLETE SUMMARY CONTENT

 \*\* REGULATORY ALERT \*\*\
 SCOPE\
 METHODOLOGY - including Rating Scheme and Cost Analysis\
 RECOMMENDATIONS\
 EVIDENCE SUPPORTING THE RECOMMENDATIONS\
 BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS\
 QUALIFYING STATEMENTS\
 IMPLEMENTATION OF THE GUIDELINE\
 INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT
CATEGORIES\
 IDENTIFYING INFORMATION AND AVAILABILITY\
 DISCLAIMER

### SCOPE

#### DISEASE/CONDITION(S)

Heart failure in patients with left ventricular systolic dysfunction

#### GUIDELINE CATEGORY

Treatment

#### CLINICAL SPECIALTY

Cardiology\
Family Practice\
Internal Medicine

#### INTENDED USERS

Pharmacists\
Physicians

#### GUIDELINE OBJECTIVE(S)

To provide recommendations for the treatment of heart failure in
patients with left ventricular systolic dysfunction

#### TARGET POPULATION

Heart failure patients with left ventricular systolic dysfunction

#### INTERVENTIONS AND PRACTICES CONSIDERED

1.  Angiotensin-converting enzyme (ACE) inhibitors

2.  Angiotensin receptor blockers (ARBs)

3.  Beta-adrenergic receptor blockers

4.  Aldosterone antagonists

5.  Oral nitrates and hydralazine

6.  Polypharmacy

7.  Diuretic therapy

8.  Digoxin

9.  Anticoagulation and antiplatelet drugs

10. Amiodarone therapy

#### MAJOR OUTCOMES CONSIDERED

-   Signs and symptoms

-   Quality of life

-   Progression of cardiac and peripheral dysfunction

-   Mortality rates

### METHODOLOGY

#### METHODS USED TO COLLECT/SELECT EVIDENCE

Searches of Electronic Databases\
Searches of Unpublished Data

#### DESCRIPTION OF METHODS USED TO COLLECT/SELECT THE EVIDENCE

Databases searched included Medline and Cochrane. In addition, the
guideline developers polled experts in specific areas for data.

#### NUMBER OF SOURCE DOCUMENTS

Not stated

#### METHODS USED TO ASSESS THE QUALITY AND STRENGTH OF THE EVIDENCE

Weighting According to a Rating Scheme (Scheme Given)

#### RATING SCHEME FOR THE STRENGTH OF THE EVIDENCE

**Level A**: Randomized, Controlled, Clinical Trials\
May be assigned based on results of a single trial

**Level B**: Cohort and Case-Control Studies\
Post hoc, subgroup analysis, and meta-analysis\
Prospective observational studies or registries

**Level C**: Expert Opinion\
Observational studies -- epidemiologic findings\
Safety reporting from large-scale use in practice

#### METHODS USED TO ANALYZE THE EVIDENCE

Review of Published Meta-Analyses\
Systematic Review

#### DESCRIPTION OF THE METHODS USED TO ANALYZE THE EVIDENCE

Not stated

#### METHODS USED TO FORMULATE THE RECOMMENDATIONS

Expert Consensus

#### DESCRIPTION OF METHODS USED TO FORMULATE THE RECOMMENDATIONS

The Heart Failure Society of America (HFSA) Guideline Committee sought
resolution of difficult cases through consensus building. Written
documents were essential to this process, because they provided the
opportunity for feedback from all members of the group. On occasion,
consensus of Committee opinion was sufficient to override positive or
negative results of almost any form or prior evidence.

#### RATING SCHEME FOR THE STRENGTH OF THE RECOMMENDATIONS

\"Is recommended\": Part of routine care\
Exceptions to therapy should be minimized.

\"Should be considered\": Majority of patients should receive the
intervention.\
Some discretion in application to individual patients should be allowed.

\"May be considered\": Individualization of therapy is indicated

\"Is not recommended\": Therapeutic intervention should not be used

#### COST ANALYSIS

A formal cost analysis was not performed and published cost analyses
were not reviewed.

#### METHOD OF GUIDELINE VALIDATION

Internal Peer Review

#### DESCRIPTION OF METHOD OF GUIDELINE VALIDATION

The process of moving from ideas of recommendations to a final document
includes many stages of evaluation and approval. Every section, once
written, had a lead reviewer and 2 additional reviewers. After a
rewrite, each section was assigned to another review team, which led to
a version reviewed by the Committee as a whole and then the Heart
Failure Society of America (HFSA) Executive Council, representing 1 more
level of expertise and experience. Out of this process emerged the final
document.

### RECOMMENDATIONS

#### MAJOR RECOMMENDATIONS

The strength of evidence (A, B, C) and strength of recommendations are
defined at the end of the \"Major Recommendations\" field.

**Angiotensin-converting Enzyme (ACE) Inhibitors**

-   ACE inhibitors are recommended for routine administration to
    symptomatic and asymptomatic patients with left ventricular ejection
    fraction (LVEF) [\<]{.underline}40%. (Strength of Evidence = A) ACE
    inhibitors should be titrated to doses used in clinical trials, as
    tolerated during concomitant up-titration of beta-blockers.
    (Strength of Evidence = C).

-   It is recommended that other therapy be substituted for ACE
    inhibitors in the following circumstances:

    -   In patients who cannot tolerate ACE inhibitors from cough,
        angiotensin receptor blockers (ARBs) are recommended. (Strength
        of Evidence = A) The combination of hydralazine and an oral
        nitrate may be considered in such patients not tolerating ARB
        therapy. (Strength of Evidence = C)

    -   Patients intolerant to ACE inhibitors from hyperkalemia or renal
        insufficiency are likely to experience the same side effects
        with ARBs. In these cases, the combination of hydralazine and an
        oral nitrate should be considered. (Strength of Evidence = C)

**Beta-adrenergic Receptor Blockers**

**Table 7.1: Summary of Recommendations for the Administration of
Beta-Blocker Therapy**

+-------------------------------+--------------------------------------+
| General                       | -   Initiate at low doses.           |
|                               |                                      |
|                               | -   Uptitrate gradually, generally   |
|                               |     no sooner than at 2-week         |
|                               |     intervals.                       |
|                               |                                      |
|                               | -   Use target doses shown to be     |
|                               |     effective in clinical trials.    |
|                               |                                      |
|                               | -   Aim to achieve target dose in 8  |
|                               |     to 12 weeks.                     |
|                               |                                      |
|                               | -   Maintain at maximum tolerated    |
|                               |     dose.                            |
+-------------------------------+--------------------------------------+
| Considerations if symptoms    | -   Adjust dose of diuretic or other |
| worsen or other side effects  |     concomitant vasoactive           |
| appear                        |     medication.                      |
|                               |                                      |
|                               | -   Continue titration to target     |
|                               |     dose after symptoms return to    |
|                               |     baseline.                        |
+-------------------------------+--------------------------------------+
| Considerations if             | -   Prolong titration interval       |
| up-titration continues to be  |                                      |
| difficult                     | -   Reduce target dose               |
|                               |                                      |
|                               | -   Consider referral to a heart     |
|                               |     failure (HF) specialist          |
+-------------------------------+--------------------------------------+
| If an acute exacerbation of   | -   Maintain therapy if possible.    |
| chronic HF occurs             |                                      |
|                               | -   Reduce dosage if necessary.      |
|                               |                                      |
|                               | -   Avoid abrupt discontinuation.    |
|                               |                                      |
|                               | -   If discontinued or reduced,      |
|                               |     reinstate gradually before       |
|                               |     discharge.                       |
+-------------------------------+--------------------------------------+

-   Beta-blockers shown to be effective in clinical trials of patients
    with HF are recommended for patients with an LVEF
    [\<]{.underline}40%. (Strength of Evidence = A)

-   The combination of a beta-blocker and an ACE inhibitor is
    recommended as routine therapy for asymptomatic patients with a LVEF
    [\<]{.underline}40%

    -   Post-myocardial infarction (MI) (Strength of Evidence = B)

    -   Non Post-MI (Strength of Evidence = C)

-   Beta-blocker therapy is recommended for patients with a recent
    decompensation of HF after optimization of volume status and
    successful discontinuation of intravenous diuretics and vasoactive
    agents, including inotropic support. Whenever possible, beta-blocker
    therapy should be initiated in the hospital setting at a low dose
    prior to discharge in stable patients. (Strength of Evidence = B)

-   Beta-blocker therapy is recommended in the great majority of
    patients with LV systolic dysfunction, even if there is concomitant
    diabetes, chronic obstructive lung disease, or peripheral vascular
    disease. Beta-blocker therapy should be used with caution in
    patients with diabetes with recurrent hypoglycemia, with asthma, or
    with resting limb ischemia. Considerable caution should be used if
    beta-blockers are initiated in patients with marked bradycardia
    (\<55 beats/min) or marked hypotension (systolic blood pressure \<80
    mm Hg). Beta-blockers are not recommended in patients with asthma
    with active bronchospasm. (Strength of Evidence = C)

-   It is recommended that beta-blockade be initiated at low doses and
    uptitrated gradually, typically no sooner than at 2-week intervals.
    Doses found to be effective in HF trials are generally achieved in 8
    to 12 weeks. Patients developing worsening HF symptoms or other side
    effects during titration may require a dosage adjustment of diuretic
    or concomitant vasoactive medications. If side effects resolve with
    medication adjustment, patients can subsequently be titrated to
    target or maximally tolerated doses. Some patients may require a
    more prolonged interval during uptitration, a temporary reduction in
    beta-blocker dose, or, in rare cases, withdrawal of therapy.
    (Strength of Evidence = B)

-   It is recommended that beta-blocker therapy be continued in most
    patients experiencing a symptomatic exacerbation of HF during
    chronic maintenance treatment. (Strength of Evidence = C)

> A temporary reduction of dose in this setting may be considered.
> Abrupt discontinuation in patients with symptomatic exacerbation
> should be avoided. (Strength of Evidence = C)
>
> If discontinued or reduced, beta-blockers should be reinstated or the
> dose should be gradually increased before the patient is discharged.

-   It is recommended that patients in whom difficulty is encountered in
    initiating, uptitrating or maintaining beta-blocker therapy be
    referred to clinicians with special expertise in HF. (Strength of
    Evidence = B)

**Angiotensin Receptor Blockers (ARBs)**

-   ARBs are recommended for routine administration to symptomatic and
    asymptomatic patients with an LVEF [\<]{.underline}40% who are
    intolerant to ACE inhibitors for reasons other than hyperkalemia or
    renal insufficiency. (Strength of Evidence = A)

-   Individual ARBs may be considered as initial therapy rather than ACE
    inhibitors for patients with the following conditions:

    -   HF Post-MI (Strength of Evidence = A)

    -   Chronic HF and systolic dysfunction (Strength of Evidence = B)

-   ARBs should be considered in patients experiencing angioedema while
    on ACE inhibitors based on their underlying risk and with
    recognition that angioedema has been reported infrequently with
    these agents. (Strength of Evidence = B)

> The combination of hydralazine and oral nitrates may be considered in
> this setting in patients who do not tolerate ARB therapy. (Strength of
> Evidence = C)

-   The routine administration of an ARB is not recommended in addition
    to ACE inhibitor and beta-blocker therapy in patients with a recent
    acute MI and LV dysfunction. (Strength of Evidence = A)

**Aldosterone Antagonists**

-   Administration of an aldosterone antagonist is recommended for
    patients with New York Heart Association (NYHA) class IV (or class
    III, previously class IV) HF from LV systolic dysfunction (LVEF
    [\<]{.underline}35%) while receiving standard therapy, including
    diuretics. (Strength of Evidence = A)

-   Administration of an aldosterone antagonist should be considered in
    patients following an acute MI, with clinical HF signs and symptoms
    and an LVEF \<40%. Patients should be on standard therapy, including
    an ACE inhibitor (or ARB) and a beta blocker. (Strength of Evidence
    = A)

-   Aldosterone antagonists are not recommended when creatinine is \>2.5
    mg/dL (or creatinine clearance is \<30 mL/min) or serum potassium is
    \>5.0 mmol/L or in conjunction with other potassium-sparing
    diuretics. (Strength of Evidence = A)

-   It is recommended that serum potassium concentration be monitored
    frequently following initiation or change in an aldosterone
    antagonist. Monitoring should reflect protocols followed in clinical
    trials. (Strength of Evidence = A)

-   In the absence of persistent hypokalemia (\<4.0 mmol/L),
    supplemental potassium is not recommended in patients taking an
    aldosterone antagonist. (Strength of Evidence = A)

**Oral Nitrates and Hydralazine**

-   A combination of hydralazine and isosorbide dinitrate is recommended
    as part of standard therapy in addition to beta-blockers and ACE
    inhibitors for African Americans with LV systolic dysfunction.

    -   NYHA III or IV HF (Strength of Evidence = A)

    -   NYHA II HF (Strength of Evidence = B) (See National Guideline
        Clearinghouse \[NGC\] summary of Heart Failure Society of
        American \[HFSA\] guideline, [Management of Heart Failure in
        Special
        Populations](http://www.guideline.gov/summary/summary.aspx?doc_id=9331&nbr=005000))

-   A combination of hydralazine and isosorbide dinitrate may be
    considered in non--African-American patients with LV systolic
    dysfunction who remain symptomatic despite optimized standard
    therapy. (Strength of Evidence = C)

**Polypharmacy**

-   Additional pharmacologic therapy should be considered in patients
    with HF due to systolic dysfunction who have persistent symptoms or
    progressive worsening despite optimized therapy with an ACE
    inhibitor and beta-blocker. The choice of specific agent will be
    influenced by clinical considerations, including renal function
    status, chronic serum potassium concentration, blood pressure, and
    volume status. The triple combination of an ACE inhibitor, an ARB,
    and an aldosterone antagonist is not recommended because of the high
    risk of hyperkalemia. (Strength of Evidence = C)

    -   Addition of an ARB. (Strength of Evidence = A)

    -   Addition of an aldosterone antagonist:

        -   for severe HF (Strength of Evidence = A)

        -   for moderate HF (Strength of Evidence = C)

    -   Addition of the combination of hydralazine/isosorbide dinitrate:

        -   for African Americans (Strength of Evidence = A)

        -   for others (Strength of Evidence = C)

-   Additional pharmacological therapy should be considered in patients
    with HF due to systolic dysfunction who are unable to tolerate a
    beta-blocker and have persistent symptoms or progressive worsening
    despite optimized therapy with an ACE inhibitor. The choice of
    specific agent will be influenced by clinical considerations,
    including renal function status, chronic serum potassium
    concentration, blood pressure and volume status. The triple
    combination of an ACE inhibitor, an ARB, and an aldosterone
    antagonist is not recommended due to the high risk of hyperkalemia.
    (Strength of Evidence = C)

    -   Addition of an ARB. (Strength of Evidence = C)

    -   Addition of an aldosterone antagonist:

        -   for severe HF (Strength of Evidence = C)

        -   for moderate HF (Strength of Evidence = C)

    -   Addition of the combination of hydralazine/isosorbide dinitrate:

        -   for African Americans (Strength of Evidence = C)

        -   for others (Strength of Evidence = C)

**Diuretic Therapy**

-   Diuretic therapy is recommended to restore and maintain normal
    volume status in patients with clinical evidence of fluid overload,
    generally manifested by congestive symptoms (orthopnea, edema, and
    shortness of breath), or signs of elevated filling pressures
    (jugular venous distention, peripheral edema, pulsatile
    hepatomegaly, and, less commonly, rales). (Strength of Evidence = A)
    Loop diuretics rather than thiazide-type diuretics are typically
    necessary to restore normal volume status in patients with HF.
    (Strength of Evidence = B)

-   The initial dose of diuretic may be increased as necessary to
    relieve congestion. Restoration of normal volume status may require
    multiple adjustments over many days and occasionally weeks in
    patients with severe fluid overload evidenced by massive edema or
    ascites. After a diuretic effect is achieved with short-acting loop
    diuretics, increasing administration frequency to twice or even 3
    times per day will provide more diuresis with less physiologic
    perturbation than larger single doses. (Strength of Evidence = B)

> Oral torsemide may be considered in patients in whom poor absorption
> of oral medication or erratic diuretic effect may be present,
> particularly those with right-sided HF and refractory fluid retention
> despite high doses of other loop diuretics. (Strength of Evidence = C)
>
> Intravenous administration of diuretics may be necessary to relieve
> congestion. (Strength of Evidence = A)
>
> Diuretic refractoriness may represent patient noncompliance, a direct
> effect of diuretic use on the kidney, or progression of underlying
> cardiac dysfunction.

-   Addition of chlorothiazides or metolazone, once or twice daily, to
    loop diuretics should be considered in patients with persistent
    fluid retention despite high-dose loop diuretic therapy. But chronic
    daily use, especially of metolazone, should be avoided if possible
    because of the potential for electrolyte shifts and volume
    depletion. These drugs may be used periodically (every other day or
    weekly) to optimize fluid management. Metolazone will generally be
    more potent and much longer-acting in this setting and in patients
    with chronic renal insufficiency, so administration should be
    adjusted accordingly. Volume status and electrolytes must be
    monitored closely when multiple diuretics are used. (Strength of
    Evidence = C)

-   Careful observation for the development of side effects, including
    electrolyte abnormalities, symptomatic hypotension, and renal
    dysfunction, is recommended in patients treated with diuretics,
    especially when used at high doses and in combination. Patients
    should undergo routine laboratory studies and clinical examination
    as dictated by their clinical response. (Strength of Evidence = B)

-   Patients requiring diuretic therapy to treat fluid retention
    associated with HF generally require chronic treatment, although
    often at lower doses than those required initially to achieve
    diuresis. Decreasing or even discontinuing diuretics may be
    considered in patients experiencing significant improvement in
    clinical status and cardiac function or in those who successfully
    restrict dietary sodium intake. These patients may undergo cautious
    weaning of diuretic dose and frequency with careful observation for
    recurrent fluid retention. (Strength of Evidence = C)

-   It is recommended that patients and caregivers be given education
    that will enable them to demonstrate understanding of the early
    signs of fluid retention and the plan for initial therapy. (Strength
    of Evidence = C)

> Selected patients may be educated to adjust daily dose of diuretic in
> response to weight gain from fluid overload (typically short-term
> weight gain of 2 to 4 lb). (Strength of Evidence = C)

**Digoxin**

-   Digoxin should be considered for patients with LV systolic
    dysfunction (LVEF [\<]{.underline}40) who have signs or symptoms of
    HF while receiving standard therapy, including ACE inhibitors and
    beta-blockers:

    -   NYHA class II-III (Strength of Evidence = A)

    -   NYHA class IV (Strength of Evidence = B)

-   It is recommended that the dose of digoxin, which should be based on
    lean body mass, renal function, and concomitant medications, should
    be 0.125 mg daily in the majority of patients and the serum digoxin
    level should be \<1.0 ng/mL. (Strength of Evidence = C)

-   Adequate control of the ventricular response to atrial fibrillation
    in patients with HF is recommended. (Level of Evidence = B)

-   High doses of digoxin (maintenance dose \>0.25 mg daily) for the
    purpose of rate control are not recommended. (Strength of Evidence =
    C)

**Anticoagulation and Antiplatelet Drugs**

-   Treatment with warfarin (goal international normalized ratio \[INR\]
    2.0 to 3.0) is recommended for all patients with HF and chronic or
    documented paroxysmal atrial fibrillation (Strength of Evidence = A)
    or a history of systemic or pulmonary emboli, including stroke or
    transient ischemic attack (Strength of Evidence = C), unless
    contraindicated.

-   It is recommended that patients with symptomatic or asymptomatic
    ischemic cardiomyopathy and documented recent large anterior MI or
    recent MI with documented LV thrombus be treated with warfarin (goal
    international normalized ratio 2.0 to 3.0) for the initial 3 months
    post-MI (Strength of Evidence = B) unless contraindicated.

> Other patients with ischemic or nonischemic cardiomyopathy and LV
> thrombus should be considered for chronic anticoagulation, depending
> on the characteristics of the thrombus, such as its size, mobility,
> and degree of calcification. (Strength of Evidence = C)

-   In the absence of the indications included in the two
    recommendations above, warfarin anticoagulation may be considered in
    patients with dilated cardiomyopathy and LVEF [\<]{.underline}35%.
    Careful assessment of the potential risks and benefits should be
    undertaken in individual patients. (Strength of Evidence = C)

-   Long-term treatment with an antithrombotic agent is recommended for
    patients with HF due to ischemic cardiomyopathy, whether or not they
    are receiving ACE inhibitors. (Strength of Evidence = B)

> Aspirin is recommended in most patients for whom anticoagulation is
> not specifically indicated because of its proven efficacy in non-HF
> patients with ischemic heart disease, its convenience, and lower cost.
> Lower doses of aspirin (75 or 81 mg) may be preferable. (Strength of
> Evidence = C)
>
> Warfarin (goal international normalized ratio 2.0 to 3.5) and
> clopidogrel (75 mg) also have prevented vascular events in post-MI
> patients and may be considered as alternatives to aspirin. (Strength
> of Evidence = B)

-   Routine use of aspirin is not recommended in patients with HF not
    from ischemic cardiomyopathy and without other evidence of
    atherosclerotic vascular disease. (Strength of Evidence = C)

-   Aspirin and an ACE inhibitor in combination may be considered for
    patients with HF where an indication for both drugs exists.
    (Strength of Evidence = C)

> Generally the lowest effective aspirin dose (75 or 81 mg/day) should
> be administered in this setting. (Strength of Evidence = C)

**Antiarrhythmic Agents**

-   Antiarrhythmic agents, including amiodarone, are not recommended for
    the primary prevention of sudden death in patients with HF.
    (Strength of Evidence = A).

-   In patients with HF and an implantable cardioverter defibrillator
    (ICD), amiodarone may be considered to reduce the frequency of
    repetitive discharges. (Strength of Evidence = C)

-   It is recommended that patients taking amiodarone therapy and
    digoxin or warfarin generally have their maintenance doses of many
    commonly used agents, such as digoxin, warfarin, and statins,
    reduced when amiodarone is initiated and then carefully monitored
    for the possibility of adverse drug interactions. Adjustment in
    doses of these drugs and laboratory assessment of drug activity or
    serum concentration after initiation of amiodarone is recommended.
    (Strength of Evidence = A)

**[Definitions]{.underline}**:

**Strength of Evidence**

**Level A**: Randomized, Controlled, Clinical Trials\
May be assigned based on results of a single trial

**Level B**: Cohort and Case-Control Studies\
Post hoc, subgroup analysis, and meta-analysis\
Prospective observational studies or registries

**Level C**: Expert Opinion\
Observational studies -- epidemiologic findings\
Safety reporting from large-scale use in practice

**Strength of Recommendations**

\"Is recommended\": Part of routine care\
Exceptions to therapy should be minimized.

\"Should be considered\": Majority of patients should receive the
intervention.\
Some discretion in application to individual patients should be allowed.

\"May be considered\": Individualization of therapy is indicated

\"Is not recommended\": Therapeutic intervention should not be used

#### CLINICAL ALGORITHM(S)

None provided

### EVIDENCE SUPPORTING THE RECOMMENDATIONS

#### TYPE OF EVIDENCE SUPPORTING THE RECOMMENDATIONS

The type of supporting evidence is identified and graded for each
recommendation (see the \"Major Recommendations\").

The recommendations are supported by randomized controlled clinical
trials, cohort and case-control studies, and expert opinion.

### BENEFITS/HARMS OF IMPLEMENTING THE GUIDELINE RECOMMENDATIONS

#### POTENTIAL BENEFITS

-   Improving symptoms and quality of life

-   Slowing the progression of cardiac and peripheral dysfunction

-   Reducing mortality

#### POTENTIAL HARMS

-   The major side effects of angiotensin-converting enzyme (ACE)
    inhibitors in patients with heart failure (HF) are hypotension and
    azotemia. The major symptomatic side effect is a dry cough that
    usually does not require discontinuation of the drug.

-   Angiotensin receptor blockers (ARBs) appear as likely as ACE
    inhibitors to produce hypotension, worsening renal function, and
    hyperkalemia.

-   Beta-blocking agents with intrinsic sympathomimetic activity are
    likely to worsen survival and should be avoided in patients with HF.

-   Abrupt withdrawal of beta-blockade should be avoided, especially in
    patients with coronary artery disease. Studies of the withdrawal of
    beta-blockade in patients with persistent left ventricular (LV)
    systolic dysfunction, but improved and stable clinical HF, have
    revealed a substantial risk of worsening HF and early death after
    beta-blocker discontinuation.

-   ACE inhibitors can have some troublesome side effects, including
    cough and angioedema, which may limit therapy with these agents.
    ARBs have been demonstrated to be well tolerated in randomized
    trials of patients judged to be intolerant of ACE inhibitors by
    their clinicians, although these primarily reflect intolerance from
    cough, skin rashes, and angioedema. Both drugs have similar effects
    on blood pressure, renal function, and potassium.

-   In addition to hyperkalemia, gynecomastia or breast pain may be
    important side effects of spironolactone.

-   Hyperkalemia is a life-threatening complication of aldosterone
    antagonists and is much more likely to occur in patients with
    diabetes or renal insufficiency or in those taking ACE inhibitors or
    ARBs.

-   Diuretics may cause activation of the rennin angiotensin-aldosterone
    system (RAAS), potentiate hypotensive effects of ACE inhibitors, and
    may decrease cardiac output, especially in patients with diastolic
    left ventricular dysfunction. Diuretics also may induce hypokalemia
    and hypomagnesemia.

-   Loop diuretics may be associated with a variety of other side
    effects that may require additional treatment to correct. Rapid
    intravenous administration of high-dose loop diuretics should be
    avoided whenever possible, because hearing loss to the point of
    deafness can result from middle ear toxicity. Skin reactions from
    photosensitivity to rashes are not uncommon, and other
    hypersensitivity reactions including interstitial nephritis may
    occur. High doses of loop diuretics can worsen glucose tolerance and
    may result in hyperuricemia and symptoms of gout, prompted by
    increased uric acid reabsorption. Thiazide diuretics share most of
    the side effects seen with loop diuretics, although an association
    with pancreatitis appears be unique to loop diuretics.

-   Post-hoc analyses of large randomized trials involving ACE
    inhibitors in HF and post-myocardial infarction (MI) have raised the
    possibility of an adverse drug interaction between aspirin (ASA) and
    ACE inhibitors.

-   There are justifiable concerns about antiarrhythmic therapy in
    patients with HF. Patients with HF are at higher risk for
    proarrhythmic effects of antiarrhythmic agents. This has been
    demonstrated with class Ia (quinidine, procainamide), class Ic, and
    class III (dofetilide) agents. Virtually all antiarrhythmic agents
    have been shown to have adverse hemodynamic effects sufficient to
    have negative consequences in patients with HF.

### QUALIFYING STATEMENTS

#### QUALIFYING STATEMENTS

It must be recognized that the evidence supporting recommendations is
based largely on population responses that may not always apply to
individuals within the population. Therefore, data may support overall
benefit of 1 treatment over another but cannot exclude that some
individuals within the population may respond better to the other
treatment. Thus guidelines can best serve as evidence-based
recommendations for management, not as mandates for management in every
patient. Furthermore, it must be recognized that trial data on which
recommendations are based have often been carried out with background
therapy not comparable to therapy in current use. Therefore, physician
decisions regarding the management of individual patients may not always
precisely match the recommendations. A knowledgeable physician who
integrates the guidelines with pharmacologic and physiologic insight and
knowledge of the individual being treated should provide the best
patient management.

### IMPLEMENTATION OF THE GUIDELINE

#### DESCRIPTION OF IMPLEMENTATION STRATEGY

An implementation strategy was not provided.

#### IMPLEMENTATION TOOLS

Pocket Guide/Reference Cards\
Slide Presentation

For information about
[availability](#identifying-information-and-availability), see the
\"Availability of Companion Documents\" and \"Patient Resources\" fields
below.

### INSTITUTE OF MEDICINE (IOM) NATIONAL HEALTHCARE QUALITY REPORT CATEGORIES

#### IOM CARE NEED

Living with Illness

#### IOM DOMAIN

Effectiveness

### IDENTIFYING INFORMATION AND AVAILABILITY

#### BIBLIOGRAPHIC SOURCE(S)

Heart Failure Society of America. Heart failure in patients with left
ventricular systolic dysfunction. J Card Fail 2006 Feb;12(1):e38-57.
\[120 references\]
[PubMed](http://www.ncbi.nlm.nih.gov/entrez/query.fcgi?cmd=Retrieve&db=pubmed&dopt=Abstract&list_uids=16500571)

#### ADAPTATION

Not applicable: The guideline was not adapted from another source.

#### DATE RELEASED

1999 (revised 2006 Feb)

#### GUIDELINE DEVELOPER(S)

Heart Failure Society of America, Inc - Disease Specific Society

#### SOURCE(S) OF FUNDING

Heart Failure Society of America, Inc

#### GUIDELINE COMMITTEE

Comprehensive Heart Failure Practice Guideline Committee

#### COMPOSITION OF GROUP THAT AUTHORED THE GUIDELINE

*Committee Members*: Kirkwood F. Adams, Jr, MD (*Co-Chair*); JoAnn
Lindenfeld, MD (*Co-Chair*); J. Malcolm O. Arnold, MD; David W. Baker,
MD; Denise H. Barnard, MD; Kenneth Lee Baughman, MD; John P. Boehmer,
MD; Prakash Deedwania, MD; Sandra B. Dunbar, RN, DSN; Uri Elkayam, MD;
Mihai Gheorghiade, MD; Jonathan G. Howlett, MD; Marvin A. Konstam, MD;
Marvin W. Kronenberg, MD; Barry M. Massie, MD; Mandeep R. Mehra, MD;
Alan B. Miller, MD; Debra K. Moser, RN, DNSc; J. Herbert Patterson,
PharmD; Richard J. Rodeheffer, MD; Jonathan Sackner-Bernstein, MD; Marc
A. Silver, MD; Randall C. Starling, MD, MPH; Lynne Warner Stevenson, MD;
Lynne E. Wagoner, MD

*HFSA Executive Council*: Gary S. Francis, MD, *President*; Michael R.
Bristow, MD, PhD; Jay N. Cohn, MD; Wilson S. Colucci, MD; Barry H.
Greenberg, MD; Thomas Force, MD; Harlan M. Krumholz, MD; Peter P. Liu,
MD; Douglas L. Mann, MD; Ileana L. Piña, MD; Susan J. Pressler, RN, DNS;
Hani N. Sabbah, PhD; Clyde W. Yancy, MD

#### FINANCIAL DISCLOSURES/CONFLICTS OF INTEREST

Committee members and reviewers from the Executive Council received no
direct financial support from the Heart Failure Society of America
(HFSA) or any other source for the development of the guideline.
Administrative support was provided by the Heart Failure Society of
America staff, and the writing of the document was performed on a
volunteer basis by the Committee. Financial relationships that might
represent conflicts of interest were collected for all members of the
Guideline Committee and of the Executive Council, who were asked to
disclose potential conflicts and recuse themselves from discussions when
necessary. Current relationships are shown in Table 1.5 of the
\"Development and Implementation\" companion document (see the
\"Availability of Companion Documents\" field).

#### GUIDELINE STATUS

This is the current release of the guideline.

This guideline updates a previous version: Heart Failure Society of
America. Heart Failure Society of America (HFSA) practice guidelines.
HFSA guidelines for management of patients with heart failure caused by
left ventricular systolic dysfunction\--pharmacological approaches. J
Card Fail 1999 Dec;5(4):357-82.

#### GUIDELINE AVAILABILITY

Electronic copies: Available from the [Heart Failure Society of America,
Inc. Web site](http://www.heartfailureguideline.com/).

Print copies: Available from the Heart Failure Society of America, Inc.,
Court International - Suite 240 S, 2550 University Avenue West, Saint
Paul, Minnesota 55114; Phone: (651) 642-1633

#### AVAILABILITY OF COMPANION DOCUMENTS

The following are available:

-   Heart Failure Society of America. Executive summary: HFSA 2006
    comprehensive heart failure practice guideline. J Card Fail 2006
    Feb;12(1):10-38.

-   Heart Failure Society of America. Development and implementation of
    a comprehensive heart failure practice guideline. J Card Fail 2006
    Feb;12(1):e3-9.

-   Heart Failure Society of America. Conceptualization and working
    definition of heart failure. J Card Fail 2006 Feb;12(1):e10-11.

> Electronic copies: Available from the [Heart Failure Society of
> America, Inc. Web site](http://www.heartfailureguideline.com/).

-   PowerPoint slides. HFSA 2006 comprehensive heart failure guideline.

> Electronic copies: Available from the [Heart Failure Society of
> America, Inc. Web
> site](http://www.heartfailureguideline.com/index.cfm?id=146&s=1).

The following is also available:

-   Heart Failure Society of America. Pocket guide. HFSA 2006
    comprehensive heart failure practice guideline.

Electronic copies: Not available at this time.

Print copies: Available from the Heart Failure Society of America, Inc.,
Court International - Suite 240 South, 2550 University Avenue West,
Saint Paul, Minnesota 55114; Phone: (651) 642-1633

#### PATIENT RESOURCES

None available

#### NGC STATUS

This NGC summary was completed by ECRI on July 31, 2006. The information
was verified by the guideline developer on August 10, 2006. This summary
was updated by ECRI on March 6, 2007 following the U.S. Food and Drug
Administration (FDA) advisory on Coumadin (warfarin sodium). This
summary was updated by ECRI Institute on September 7, 2007 following the
revised U.S. Food and Drug Administration (FDA) advisory on Coumadin
(warfarin).

#### COPYRIGHT STATEMENT

This NGC summary is based on the original guideline, which is subject to
the guideline developer\'s copyright restrictions. Please direct
inquiries to <info@hfsa.org>.

### DISCLAIMER

#### NGC DISCLAIMER

The National Guideline Clearinghouse™ (NGC) does not develop, produce,
approve, or endorse the guidelines represented on this site.

All guidelines summarized by NGC and hosted on our site are produced
under the auspices of medical specialty societies, relevant professional
associations, public or private organizations, other government
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Guidelines represented on the NGC Web site are submitted by guideline
developers, and are screened solely to determine that they meet the NGC
Inclusion Criteria which may be found at
<http://www.guideline.gov/about/inclusion.aspx> .

NGC, AHRQ, and its contractor ECRI Institute make no warranties
concerning the content or clinical efficacy or effectiveness of the
clinical practice guidelines and related materials represented on this
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Readers with questions regarding guideline content are directed to
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Date Modified: 11/3/2008