CONSENSUS
Trial question
What is the role of enalapril in patients with congestive HF and NYHA class IV symptoms?
Study design
Multi-center
Double blinded
RCT
Population
Characteristics of study participants
30.0% female
70.0% male
N = 253
253 patients (75 female, 178 male)
Inclusion criteria: patients with congestive HF and NYHA class IV symptoms who were taking conventional treatment for HF
Key exclusion criteria: acute pulmonary edema, hemodynamically important aortic or mitral valve stenosis, myocardial infarction within the previous two months, or unstable angina
Interventions
N=127 enalapril (initial dose of 5 mg BID, maximum dose of 20 mg BID)
N=126 placebo (matching placebo BID)
Primary outcome
Death at 6 months
26
44
44.0 %
33.0 %
22.0 %
11.0 %
0.0 %
Enalapril
Placebo
Significant
decrease ▼
NNT = 5
Significant decrease in death at 6 months (26% vs. 44%; RR 0.65, 95% CI 0.24 to 1.06)
Secondary outcomes
Significant decrease in cardiac death due to progression of congestive HF (17.3% vs. 34.9%; RR 0.5, 95% CI 0.2 to 0.8)
Safety outcomes
No significant difference in overall withdrawal rates.
Significant difference in hypotension requiring withdrawal (7 vs. 0).
Conclusion
In patients with congestive HF and NYHA class IV symptoms who were taking conventional treatment for HF, enalapril was superior to placebo with respect to death at 6 months.
Reference
CONSENSUS Trial Study Group. Effects of enalapril on mortality in severe congestive heart failure. Results of the Cooperative North Scandinavian Enalapril Survival Study (CONSENSUS). N Engl J Med. 1987 Jun 4;316(23):1429-35.
Open reference URL