V-HeFT (hydralazine/nitrate)
Trial question
What is the role of hydralazine/nitrate in patients with chronic HF and LVEF?
Study design
Multi-center
Double blinded
RCT
Population
459 patients.
Inclusion criteria: patients with chronic HF and LVEF < 45% who were taking digoxin and a diuretic.
Key exclusion criteria: exercise tolerance limited by chest pain; MI within the previous 3 months' substantial obstructive valvular disease; chronic pulmonary disease.
Interventions
N=186 hydralazine and isosorbide dinitrate (300 mg/160 mg daily).
N=273 placebo (matching placebo).
Primary outcome
Death at 2 years
25.6%
34.3%
34.3 %
25.7 %
17.1 %
8.6 %
0.0 %
Hydralazine and isosorbide
dinitrate
Placebo
Significant
decrease ▼
NNT = 11
Significant decrease in death at 2 years (25.6% vs. 34.3%; RR 0.66, 95% CI 0.46 to 0.96).
Secondary outcomes
No significant difference in improvement in ejection fraction at 1 year (4.2% vs. -0.1%; AD 4.3%, 95% CI -0.83 to 9.43).
Safety outcomes
No significant difference in treatment discontinuation.
Conclusion
In patients with chronic HF and LVEF < 45% who were taking digoxin and a diuretic, hydralazine and isosorbide dinitrate were superior to placebo with respect to death at 2 years.
Reference
Cohn JN, Archibald DG, Ziesche S et al. Effect of vasodilator therapy on mortality in chronic congestive heart failure. Results of a Veterans Administration Cooperative Study. N Engl J Med. 1986 Jun 12;314(24):1547-52.
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