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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 trialMulticenter, randomized, double-blind, placebo- controlled trial 642 men followed for an average of 2.3 years642 men followed for an average of 2.3 years Patient History: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 echocardiographyIn addition to mortality, the follow-up data included EF, exercise tolerance and echocardiography N Engl J Med 1986;314:1547-52
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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 diureticsTo 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)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
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V-HEFT I Cumulative Mortality from the Time of Randomization in the Three Treatment Groups N Engl J Med 1986;314:1547-52
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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 significanceMortality 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 two years in the Hyd-Iso group was 34% (p=0.028) Risk reduction at three years in the Hyd-Iso group was 36%Risk reduction at three years in the Hyd-Iso group was 36% Mortality in the prazosin group was similar to placeboMortality 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.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
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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”“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
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