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RALES
About the Trial
The Randomized Aldactone Evaluation Study randomized 1,663 patients with severe heart failure, ejection fraction under 35 percent, to spironolactone or placebo. The trial stopped early after 24 months: spironolactone reduced all cause mortality by 30 percent and hospitalization by 35 percent. Aldosterone, not just angiotensin II, drives cardiac fibrosis and sodium retention. The drug cost pennies and saved lives at spectacular cost effectiveness. Serious hyperkalemia was uncommon in the trial, though population studies later reported rises as use spread. RALES completed the neurohormonal blockade triad of ACE inhibitor, beta blocker, and mineralocorticoid antagonist that remains the foundation of heart failure therapy.
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