The Effects of Vasodilator Therapy on Mortality in Chronic Congestive Heart failure - VHEFT-I

Description:

Hydralazine for mortality in symptomatic heart failure.

Hypothesis:

Vasodilator therapy improves survival in symptomatic patients with heart failure and left ventricular dysfunction on digitalis and diuretics.

Study Design

Study Design:

Patients Screened: Not given
Patients Enrolled: 642
Mean Follow Up: 2.3 years (6 months - 5.7 years)
Mean Patient Age: 58
Female: 0
Mean Ejection Fraction: 30%

Patient Populations:

Males aged 18-75 years
Cardiac enlargement or reduced left ventricular ejection fraction (< 45%)
Reduced exercise tolerance

Exclusions:

Exercise limited by chest pain
Recent myocardial infarction (prior 3 months)
Co-morbid diseases likely to limit five year survival
Treatment with long-acting nitrates, calcium channel blockers or beta blockers
Treatment with antihypertensive drugs other than diuretics

Primary Endpoints:

Mortality (all cause)
Cumulative mortality at 2 years

Secondary Endpoints:

Change in left ventricular ejection fraction

Drug/Procedures Used:

Hydralazine (average of 270mg QID)
Isosorbide dinitrate (average of 136mg QID)
Prazosin (average of 18mg QID)

Concomitant Medications:

Antiarrhythmic drugs (27%)
Anticoagulants (20%)

Principal Findings:

Hydralazine/isosorbide dinitrate decreased 2 year mortality by 34% (p < 0.028) compared to placebo.

Significant improvement in left ventricular ejection fraction in eight weeks and one year in hydralazine/isosorbide dinitrate group but not placebo or prazosin.

Increased drug-related side-effects in hydralazine/isordil group; only 55% of patients were taking full dose of both drugs by six months of randomization.

No beneficial effect of prazosin on outcome compared to placebo.

Insufficient data to evaluate mortality beyond three years.

Interpretation:

"Data suggest that the addition of hydralazine and isosorbide dinitrate to the therapeutic regimen of digoxin and diuretics in patients with chronic congestive heart failure can have a favorable effect on left ventricular function and mortality." (From Abstract)

References:

1. N Engl J Med 1986;314:1547-52. Final results

Clinical Topics: Heart Failure and Cardiomyopathies, Acute Heart Failure

Keywords: Exercise Tolerance, Digoxin, Diuretics, Vasodilator Agents, Isosorbide Dinitrate, Drug Combinations, Hydralazine, Sympatholytics, Nitrates, Heart Failure, Digitalis, Stroke Volume, Prazosin, Ventricular Dysfunction, Left


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