Aldosterone Antagonist Therapy for Adults With Heart Failure and Preserved Systolic Function
(TOPCAT Trial)

Recruiting in Palo Alto (17 mi)

+269 other locations

Overseen bySonja M. McKinlay, PhD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: HealthCore-NERI

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

What is the purpose of this trial?

The purpose of this study is to evaluate the effectiveness of aldosterone antagonist therapy in reducing cardiovascular mortality, aborted cardiac arrest, and heart failure hospitalization in patients who have heart failure with preserved systolic function.

Research Team

Sonja M. McKinlay, PhD

Principal Investigator

New England Research Institutes, Inc.

Eligibility Criteria

Inclusion Criteria

left ventricular ejection fraction greater than or equal to 45% (per local reading); the ejection fraction must have been obtained within 6 months prior to randomization and after any MI or other event that would affect ejection fraction

Controlled systolic blood pressure(BP), defined as a target systolic BP less than 140 mm Hg; participants with BP up to and including 160 mm Hg are eligible for enrollment if they are on three or more medications to control BP

Serum potassium less than 5.0 mmol/L prior to randomization

See 4 more

Treatment Details

Interventions

Placebo (Drug)
Spironolactone (Aldosterone Antagonist)

Participant Groups

2Treatment groups

Experimental Treatment

Placebo Group

Group I: SpironolactoneExperimental Treatment1 Intervention

Spironolactone (an aldosterone antagonist) is supplied as 15 mg tablets. Drug is taken orally by subjects. The initial study drug dose is 15 mg/day (one tablet) and may be titrated up to 30 mg/day (two tablets) or 45 mg/day (three tablets). Subjects are on study drug for the duration of the trial.

Group II: PlaceboPlacebo Group1 Intervention

Placebo of spironolactone