V-HeFT II
Trial question
What is the role of enalapril in male patients with HF and LV dilation or a LVEF < 45%?
Study design
Multi-center
Double blinded
RCT
Population
804 male patients.
Inclusion criteria: male patients with HF and LV dilation or an LVEF < 45%.
Key exclusion criteria: MI or cardiac surgery within the previous three months, angina pectoris limiting exercise or requiring long-term medical therapy, serious obstructive valvular disease, or obstructive lung disease.
Interventions
N=403 enalapril (20 mg daily).
N=401 hydralazine-isosorbide dinitrate arm (300 mg hydralazine plus 160 mg isosorbide dinitrate daily).
Primary outcome
Death at 2 years
18%
25%
25.0 %
18.8 %
12.5 %
6.3 %
0.0 %
Enalapril
Hydralazine-isosorbide dinitrate
arm
Significant
decrease ▼
NNT = 14
Significant decrease in death at 2 years (18% vs. 25%; RR 0.72, 95% CI 0.13 to 1.31).
Secondary outcomes
No significant difference in death in presence of coronary artery disease (14.1% vs. 14.3%; RR 0.87, 95% CI 0.64 to 1.19).
Conclusion
In male patients with HF and LV dilation or an LVEF < 45%, enalapril was superior to hydralazine-isosorbide dinitrate arm with respect to death at 2 years.
Reference
Cohn JN, Johnson G, Ziesche S et al. A comparison of enalapril with hydralazine-isosorbide dinitrate in the treatment of chronic congestive heart failure. N Engl J Med. 1991 Aug 1;325(5):303-10.
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