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QUESTION: In patients with severe congestive heart failure (CHF) caused by systolic left ventricular dysfunction, does spironolactone combined with usual care reduce all-cause mortality?
Randomised (allocation concealed*), blinded (patients, clinicians, and outcome assessors),* placebo-controlled trial with mean follow-up of 24 months. Interim analyses were done.
195 clinical centres in 15 countries.
1663 patients (mean age 65 y, 73% men, 87% white) with severe CHF who were using angiotensin-converting enzyme (ACE) inhibitors, if tolerated, and a loop diuretic and had had a recent left ventricular ejection fraction ≤35%. The major exclusion criterion was use of potassium-sparing diuretics. All patients were analysed.
All patients received usual care and were allocated to spironolactone, 25 mg/day, which could be doubled after 8 weeks …