A-HeFT
Trial question
What is the role of isosorbide dinitrate plus hydralazine in black patients with HF?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
40.0% female
60.0% male
N = 1050
1050 patients (420 female, 630 male)
Inclusion criteria: black patients who had NYHA class III or IV HF with dilated ventricles
Key exclusion criteria: recent acute myocardial infarction, acute coronary syndrome, or stroke; recent cardiac surgery or PCI; clinically significant valvular heart disease, hypertrophic or restrictive cardiomyopathy; or symptomatic hypotension
Interventions
N=518 oral vasodilator therapy (120 mg of isosorbide dinitrate plus 225 mg of hydralazine and standard therapy for HF)
N=532 placebo (matching placebo plus standard therapy for HF)
Primary outcome
Significant decrease in death from any cause, a first hospitalization for HF, and change in the QoL (-0.1 vs. -0.5 ; AD -0.4 , 95% CI -0.7 to -0.1)
Secondary outcomes
Significant decrease in death from any cause (6.2% vs. 10.2%; HR 0.57, 95% CI 0.09 to 1.05)
Significant decrease in first hospitalization for HF (16.4% vs. 24.4%; RR 0.67, 95% CI 0.27 to 1.07)
Significant decrease in improvement in QoL score at 6 months (-5.6 vs. -2.7 ; AD -2.9 , 95% CI -5.35 to -0.45)
Safety outcomes
Significant differences in headache (47.5% vs. 19.2%), dizziness (29.3% vs. 12.3%), severe exacerbation of congestive HF (3.1% vs. 7.0%).
Conclusion
In black patients who had NYHA class III or IV HF with dilated ventricles, oral vasodilator therapy was superior to placebo with respect to death from any cause, a first hospitalization for HF, and change in the QoL.
Reference
Taylor AL, Ziesche S, Yancy C et al. Combination of isosorbide dinitrate and hydralazine in blacks with heart failure. N Engl J Med. 2004 Nov 11;351(20):2049-57.
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