This subproject is one of many research subprojects utilizing theresources provided by a Center grant funded by NIH/NCRR. The subproject andinvestigator (PI) may have received primary funding from another NIH source,and thus could be represented in other CRISP entries. The institution listed isfor the Center, which is not necessarily the institution for the investigator.This trial is a multicenter, international, randomized, double blind placebo-controlled trial of thealdosterone antagonist, spironolactone, in 4500 adults with heart failure and left ventricularejection fraction of at least 45%, recruited from over 150 clinical centers. The primary endpointis a composite of cardiovascular mortality, aborted cardiac arrest or hospitalization for themanagement of heart failure. Secondary endpoints include all-cause mortality, new onset ofdiabetes mellitus, atrial fibrillation, and quality of life. The trial duration is 4.5 years, with 2.5years for subject enrollment and an additional 2 years of follow-up, for an average subjectfollow-up of 3.25 years. Dynamic balancing by clinical center at the time of randomization will beused to ensure that the distribution of clinical centers are similar in the two treatment groups.
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