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Polypill for Prevention of Cardiomyopathy

RecruitingPhase 1, Phase 2Ages 18 Years - 100 YearsAllUniversity of Texas Southwestern Medical Center
NCT06143566 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Polypill
  • Combined prescription of the individual medications
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Where

1 site
UT Southwestern Medical Center
Dallas, United States
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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