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Polypill for Prevention of Cardiomyopathy
Sponsor: University of Texas Southwestern Medical Center
Summary
This study will investigate the utility of a polypill-based strategy for patients with type 2 diabetes mellitus and high risk of heart failure (HF), as assessed via the WATCH-DM risk score. Polypill therapy will consist of empagliflozin 12.5 mg, losartan 25, 50 or 100 mg, and finerenone 10 mg daily. The study duration is 6 months, and participants will be randomized to either polypill therapy or simultaneous prescription of the individual drugs. The primary outcome is change in peak VO2 and adherence to usual care. The investigators hypothesize that the use of a polypill is feasible and improves medication adherence and peak VO2 as compared to those receiving usual care.
Official title: Polypill Strategy for Prevention of Cardiomyopathy Among Patients With Diabetes at Risk of Heart Failure
Key Details
Gender
All
Age Range
18 Years - 100 Years
Study Type
INTERVENTIONAL
Enrollment
200
Start Date
2024-03-11
Completion Date
2027-12-01
Last Updated
2025-06-17
Healthy Volunteers
No
Conditions
Interventions
Polypill
A combination of finerenone 10 mg, empagliflozin 12.5 mg, and losartan 50 mg or 100 mg within a polycapsule.
Combined prescription of the individual medications
We will initiate participants on an ARB, SGLT2i, and Finerenone if they are not in the polypill arm.
Locations (1)
UT Southwestern Medical Center
Dallas, Texas, United States