6/27/23, 11:43 PM A-HeFT Pathway Feedback Search Clinical Topics Home Studies A HeFT A HeFT Disease Heart failure 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 N = 1050 60.0% male 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 VHD, 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 https://web.pathway.md/studies/recEL54fj13TzPPoN 1/2 6/27/23, 11:43 PM A-HeFT Pathway Significant decrease in death from any cause, a first hospitalization for HF, and change in the quality of life (-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 quality of life 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 quality of life. 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. Open reference URL https://web.pathway.md/studies/recEL54fj13TzPPoN 2/2