Overview

Polypill for Prevention of Cardiomyopathy

Status:
Recruiting
Trial end date:
2024-12-01
Target enrollment:
Participant gender:
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 50 or 100 mg, and finerenone 10 mg daily. The study duration is 3 months, and participants will be randomized to either polypill therapy or usual care. 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.
Phase:
Phase 1/Phase 2
Details
Lead Sponsor:
University of Texas Southwestern Medical Center
Treatments:
Empagliflozin
Losartan