NCT06143566RecruitingPhase 1/2
Polypill for Prevention of Cardiomyopathy
Polypill Strategy for Prevention of Cardiomyopathy Among Patients With Diabetes at Risk of Heart Failure
Source: ClinicalTrials.gov · Last updated 4 Aug 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 1/2
- Study type
- Interventional
- Enrollment
- 200 (estimated)
- First submitted
- 16 Nov 2023
- Start date
- 11 Mar 2024
- Primary completion date
- 1 Sept 2027
- Lead sponsor
- University of Texas Southwestern Medical Center
- Diseases
- Heart failure, High blood pressure, Type 2 diabetes
- NCT number
- NCT06143566
What you commit to
- Study type: Interventional · Phase 1/2
- Planned participants: 200
- From 11 Mar 2024 to the primary completion date, 1 Sept 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Congestive heart failure
Lab values
- eGFR \< 25
- Creatinine \>2.0mg/dL in men and \>1.8mg/dL in women
Other
- Hyperkalemia \> 5.0
- Contraindication to any component of polypill
- Pregnancy
- Inability to calculate WATCH-DM score
- Inability to undergo exercise testing
Who the study is looking for
- 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
Age in the registry: 18 years to 100 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| UT Southwestern Medical Center Coordinator of this site? Confirm its status | Dallas | United States | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.