The Effect of Spironolactone on Morbidity and Mortality in Patients with Severe Heart Failure Bertram Pitt, Faiez Zannad, Willem J. Remme, Robert Cody, Alain Castaigne, Alfonso Perez, Jolie Palensky, Janet Wittes, for the Randomized Aldactone Evaluation Study Investigators Abstract Background and Methods.
Aldosterone is important in the pathophysiology of heart failure.
A total of 822 patients were randomly assigned to receive 25 mg of spironolactone daily, and 841 to receive placebo. The primary end point was death from all causes. The trial was discontinued early, after a mean follow-up period of 24 months, because an interim analysis determined that spironolactone was efficacious. Blockade of aldosterone receptors by spironolactone, in addition to standard therapy, substantially reduces the risk of both morbidity and death among patients with severe heart failure. Other investigators are listed in the Appendix.