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Aldosterone Antagonist Therapy for Adults With Heart Failure and Preserved Systolic Function (TOPCAT Trial)
Phase 3
Waitlist Available
Led By Sonja M. McKinlay, PhD
Research Sponsored by HealthCore-NERI
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.
Awards & highlights
Approved for 10 Other Conditions
Pivotal Trial
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.
Eligible Conditions
- Congestive Heart Failure
- Cardiovascular Disease
- Single Ventricle Heart Disease
- Heart Disease
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~randomization through each subject's last semi-annual visit, up to a maximum of 6 years per subject.
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Secondary study objectives
Aborted Cardiac Arrest
Cardiovascular-related Hospitalization
Chloride
+15 moreSide effects data
From 2022 Phase 4 trial • 79 Patients • NCT021690898%
Hypotension
5%
Hyperkalemia
5%
Infection
5%
Diabetes related
3%
Surgical
3%
Chest pain/discomfort
3%
Breast tenderness/Gynecomastia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Spironolactone
Placebo
Awards & Highlights
Approved for 10 Other Conditions
This treatment demonstrated efficacy for 10 other conditions.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
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
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Spironolactone
FDA approved
Find a Location
Who is running the clinical trial?
HealthCore-NERILead Sponsor
72 Previous Clinical Trials
107,532 Total Patients Enrolled
Carelon ResearchLead Sponsor
75 Previous Clinical Trials
121,249 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,943 Previous Clinical Trials
47,794,454 Total Patients Enrolled
Sonja M. McKinlay, PhDPrincipal InvestigatorNew England Research Institutes, Inc.