At a glance
ClinicalIndex Comparison Record- ✓Heart failure with at least one symptom (paroxysmal nocturnal dyspnea, orthopnea, or dyspnea on mild/moderate exertion) AND at least one sign (rales post-cough, JVP ≥10 cm H2O, lower extremity edema, or chest X-ray findings) within 12 months
- ✓LVEF ≥45% documented within 6 months prior to randomization and after any MI or event affecting ejection fraction
- ✓Systolic BP <140 mm Hg, or up to 160 mm Hg if on ≥3 antihypertensive medications
- ✓Serum potassium <5.0 mmol/L prior to randomization
- ✕eGFR <30 mL/min OR serum creatinine ≥2.5 mg/dL
- ✕History of hyperkalemia (K ≥5.5 mmol/L) in past 6 months or K ≥5.0 mmol/L within past 2 weeks
- ✕Use of aldosterone antagonist or potassium-sparing medication in past 14 days, or any condition requiring such during study
- ✕Known intolerance to aldosterone antagonists
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Treatment of Preserved Cardiac Function Heart Failure With an Aldosterone Antagonist (TOPCAT)
In Brief
A Phase 3 clinical trial evaluating Spironolactone and Placebo for Cardiovascular Diseases and 2 related conditions. Completed, enrolled 3,445 participants across 270 sites in 6 countries.
Detailed Summary
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.
Study Details
Timeline
Interventions
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.
Placebo of spironolactone