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Polypill for Prevention of Cardiomyopathy

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…

ClinicalTrials.gov IDNCT06143566

PhasePHASE1, PHASE2

Enrollment200

SponsorUniversity of Texas Southwestern Medical Center

Age18 Years – 100 Years

SexALL

I'm interested View official listing

Conditions studied

Type 2 Diabetes, High Blood Pressure

About this study

Interventions

Drug: Polypill — A combination of finerenone 10 mg, empagliflozin 12.5 mg, and losartan 50 mg or 100 mg within a polycapsule.
Drug: Combined prescription of the individual medications — We will initiate participants on an ARB, SGLT2i, and Finerenone if they are not in the polypill arm.

Primary outcomes

Oxygen uptake during peak exercise (Peak VO2) (Baseline, 3-month, and 6-month)

Eligibility information

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

Study locations

UT Southwestern Medical Center, Dallas, Texas 75235 United States

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-10-08.