CONSENSUS

CONSENSUS

What is the role of enalapril in patients with congestive HF and NYHA class IV symptoms?

Study design

Population

• 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

Significant decrease in death at 6 months (26% vs. 44%; RR 0.65, 95% Cl 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% Cl 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.