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RecruitingPhase 1Phase 2NCT06143566

Polypill for Prevention of Cardiomyopathy

Polypill Strategy for Prevention of Cardiomyopathy Among Patients With Diabetes at Risk of Heart Failure

Sponsor

University of Texas Southwestern Medical Center

Enrollment

200 participants

Start Date

Mar 11, 2024

Study Type

INTERVENTIONAL

Conditions

Type 2 DiabetesHigh Blood Pressure

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.

Eligibility

Min Age: 18 YearsMax Age: 100 Years

Plain Language Summary

Simplified for easier understanding

This trial tests a combination pill (polypill) containing multiple heart-protective medications in people with Type 2 diabetes and chronic kidney disease who are at high risk of developing a form of heart muscle disease (cardiomyopathy). **You may be eligible if...** - You have Type 2 diabetes - You have chronic kidney disease with mildly to moderately reduced kidney function - You are at high risk for heart failure, as indicated by special heart markers in your blood, an abnormal heart ultrasound, or a high score on a diabetes-related heart risk calculator **You may NOT be eligible if...** - Your kidneys are severely impaired - You already have congestive heart failure - Your blood potassium levels are too high - You are unable to take any component of the polypill - You are pregnant - Your creatinine level is too high - You are unable to exercise on a treadmill or stationary bike for testing Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGPolypill

A combination of finerenone 10 mg, empagliflozin 12.5 mg, and losartan 50 mg or 100 mg within a polycapsule.

DRUGCombined 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

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NCT06143566

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