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Polypill for Prevention of Cardiomyopathy
Polypill Strategy for Prevention of Cardiomyopathy Among Patients With Diabetes at Risk of Heart Failure
Who can join
Ages 18 to 100 · All sexes
Full eligibility criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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
About the study
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.
What is being tested
- Polypill (drug)
- Combined prescription of the individual medications (drug)
Sponsor: University of Texas Southwestern Medical Center · Participants: 200 · Started: Mar 11, 2024
Contact the study team
- Ambarish Pandey, MD, MSCS · Phone: 214-645-2101
Official record on ClinicalTrials.gov — NCT06143566
Locations in the U.S.
| Texas | UT Southwestern Medical Center, Dallas |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.