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Effect of Vasodilator Therapy on Mortality in Chronic Congestive Heart Failure Results of a Veterans Administration Cooperative Study (V-HEFT I)
Multicenter, randomized, double-blind, placebo-controlled trial
642 men followed for an average of 2.3 years
Patient History:
Men with impaired cardiac function and reduced exercise tolerance
All patients were taking digoxin and diuretics
In addition to mortality, the follow-up data included EF, exercise tolerance and echocardiography
N Engl J Med 1986;314:1547-52
V-HEFT I Objectives
To evaluate the effects of vasodilator therapy on mortality among patients with chronic congestive heart failure, impaired cardiac function and reduced exercise tolerance who were taking digoxin and diuretics
Patients were randomized to double-blind treatment with placebo, prazosin (20 mg per day), or the combination of hydralazine (300 mg per day) and isosorbide dinitrate (160 mg per day)
N Engl J Med 1986;314:1547-52
V-HEFT I Cumulative Mortality from the Time of Randomization in the Three Treatment Groups
N Engl J Med 1986;314:1547-52
V-HEFT I Results
Mortality over the entire follow-up period was lower in the Hyd-Iso group vs. placebo. The difference was of borderline statistical significance
Risk reduction at two years in the Hyd-Iso group was 34% (p=0.028)
Risk reduction at three years in the Hyd-Iso group was 36%
Mortality in the prazosin group was similar to placebo
EF rose significantly at eight weeks and at one year in the Hyd-Iso group but not in the placebo or prazosin groups.
N Engl J Med 1986;314:1547-52
V-HEFT I Conclusion
“The data suggests that the addition of hydralazine and isosorbide nitrate 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”
N Engl J Med 1986;314:1547-52