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A Comparison of Enalapril with Hydralazine Isosorbide Dinitrate in the Treatment of Chronic Congestive Heart failure - VHEFT-II
Description:
Enalapril vs. hydralazine/nitrates for mortality in moderate heart failure.
Hypothesis:
Enalapril will reduce mortality more than the combination of hydralazine-isosorbide dinitrate in patients with moderately severe congestive heart failure.
Study Design
Study Design:
Patients Screened: 2,741
Patients Enrolled: 804
NYHA Class: I=(6%), II=(51%),III=(43%)
Mean Follow Up: 2.5 years (6 months - 5.7 years)
Mean Patient Age: 60
Female: 0
Mean Ejection Fraction: 29%
Patient Populations:
Men ages 18-75 (chronic heart failure)
Evidence of cardiac dysfunction - CT ratio > 0.55, left ventricular dimension > 2.7 cm/sqm BSA, or EF < 45% in association with reduced exercise tolerance
Exclusions:
MI or cardiac surgery in prior 3 months
Angina limiting exercise
Obstructive valvular disease
Obstructive pulmonary disease
Primary Endpoints:
Overall 2 year mortality
Secondary Endpoints:
Ejection fraction
Exercise capacity (peak oxygen consumption)
Clinical assessment
Plasma norepinephrine
Drug/Procedures Used:
Enalapril (20 mg/day)
Hydralazine/Isosorbide dinitrate (300/160 mg)
Concomitant Medications:
Nitroglycerin (16%)
Antiarrhythmics (25%)
Anticoagulants (21%)
Digoxin (100%)
Diuretics (100%)
Principal Findings:
Two year mortality significantly lower in Enalapril group (18% versus 25%; p = 0.016)
Overall mortality also lower with Enalapril but did not reach statistical significance for duration of follow-up (p = 0.08).
Lower mortality in Enalapril group due to lower incidence of sudden death.
Ejection fraction increased in both groups but was significantly greater in hydralazine/isosorbide dinitrate group.
Increased oxygen consumption in hydralazine/isosorbide dinitrate group at 13 weeks and 6 months; after one year, peak oxygen consumption declined in both groups.
Interpretation:
Enalapril improved mortality more than hydralazine/isosorbide dinitrate in this study and had significant impact on exercise and LVEF. Survival curves of hydralazine/isosorbide dinitrate group from VHeFT I and II are almost identical. ACE inhibitors seem to improve outcome in congestive heart failure by different mechanisms than directly acting vasodilators.
References:
1. N Engl J Med 1991;325:303-10. Final results
Keywords: Exercise Tolerance, Isosorbide Dinitrate, Drug Combinations, Enalapril, Follow-Up Studies, Hydralazine, Oxygen Consumption, Nitrates, Heart Failure, Death, Sudden, Cardiac, Vasodilator Agents
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