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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, placebocontrolled 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 Cumulative Mortality Rate 0.6 Placebo Prazosin Hyd-Iso 0.5 0.4 0.3 0.2 0.1 0 0 6 N Engl J Med 1986;314:1547-52 12 18 24 Interval (months) 30 36 42 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