Polypill for Prevention of Cardiomyopathy

Recruiting now · Phase 1/Phase 2

Conditions studied: Type 2 Diabetes, High Blood Pressure

In brief

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.

Key facts

Study ID

NCT06143566

Run by

University of Texas Southwestern Medical Center

People needed

200

Starts

2024-03-11

Expected to finish

2027-12-01

Last updated by the study team

2026-08-04

Who can join

Age: 18 and older, up to 100. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients with Type 2 DM
• History of chronic kidney disease, defined as an estimated glomerular filtration rate (eGFR) of 25 to 90 per minute per 1.73 m2 of body-surface area (stage 2 to 4 CKD) with a urinary albumin-to-creatinine ratio (with albumin measured in milligrams and creatinine measured in grams) of less than 5000
• With either a: High risk of HF as defined by High Watch-DM score (≥11) or Elevated natriuretic peptides or Diastolic dysfunction or left ventricular hypertrophy on echocardiography

You may not qualify if…

• eGFR < 25
• Congestive heart failure
• Hyperkalemia > 5.0
• Contraindication to any component of polypill
• Pregnancy
• Creatinine >2.0mg/dL in men and >1.8mg/dL in women
• Inability to calculate WATCH-DM score
• Inability to undergo exercise testing

Where it is running

• UT Southwestern Medical Center — Dallas, Texas, United States (enrolling)

Full record on ClinicalTrials.gov

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