Polypill for Prevention of Cardiomyopathy in Type 2 Diabetes

This study is looking at a new way to prevent heart problems (cardiomyopathy) in people with Type 2 Diabetes and high blood pressure. It compares a "polypill" – a single capsule containing finerenone, empagliflozin, and losartan – to taking these three medications separately. The study wants to see if the polypill helps you take your medicine more consistently and improves your body's ability to use oxygen during exercise (Peak VO2). You might be able to join if you are 18 to 100 years old, have Type 2 Diabetes, and chronic kidney disease with a specific kidney function (eGFR of 25 to 90). The study will last 6 months. The current status of the study is unclear.

Study design: This interventional study plans to enroll 200 participants. You would be randomly assigned to either receive the polypill or the individual medications.
What's involved: You would have measurements taken at the start, 3 months, and 6 months to check your oxygen uptake during peak exercise.
Compensation: Not stated in the trial record.
Follow-up: Your oxygen uptake will be measured at 6 months, which is the end of the study's observation period.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

Polypill for Prevention of Cardiomyopathy

Recruiting

PHASE1Ages 18+InterventionalTreatment

University of Texas Southwestern Medical Center

~200 participants

Updated 2026-08-04 on ClinicalTrials.gov

What's tested:PolypillCombined prescription of the individual medications

At a glance

Recruiting sites

1 of 1 listed site is recruiting right now

RecruitingSuspended, closed, or not yet open

What they're measuring

Oxygen uptake during peak exercise (Peak VO2)

Measured over Baseline, 3-month, and 6-month

Conditions

Type 2 Diabetes

High Blood Pressure

Where it's being run

1 sites across 1 states

Texas1

Study leadership

Ambarish Pandey, MD, MSCS · PRINCIPAL_INVESTIGATOR · UT Southwestern

Who to contact

Ambarish Pandey, MD, MSCS

[email protected]

214-645-2101

Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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

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

What this trial measures

Oxygen uptake during peak exercise (Peak VO2)Baseline, 3-month, and 6-month
The ability of a polypill to improve or prevent declines in exercise capacity as measured by changes in peak oxygen uptake at exercise will be assessed.

Trialytics