Transcript V-Heft I Study - Clinical Trial Results

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