Topcat library3/24/2024 1 However, significant differences in the clinical profiles, event rates, and responses to spironolactone were identified between the patients who were enrolled in the trial in the Americas (United States, Canada, Brazil, and Argentina) and the patients who were enrolled in Russia and Georgia, and these differences have aroused concerns about study conduct at the Russian and Georgian sites. The investigators found that the incidence of the primary composite end point of death from cardiovascular causes, hospitalization for heart failure, or resuscitated cardiac arrest was not significantly lower in the spironolactone group than in the placebo group, but the incidence of hospitalization for heart failure was significantly lower in the spironolactone group. In the Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist (TOPCAT) trial, patients with heart failure and preserved ejection fraction were randomly assigned to receive either spironolactone or placebo.
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