Actively Recruiting
Polypill for Prevention of Cardiomyopathy
Led by University of Texas Southwestern Medical Center · Updated on 2025-06-17
200
Participants Needed
1
Research Sites
194 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Polypill for Prevention of Cardiomyopathy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patients with Type 2 diabetes mellitus
- History of chronic kidney disease with an estimated glomerular filtration rate (eGFR) between 25 and 90 per minute per 1.73 m2
- Urinary albumin-to-creatinine ratio less than 5000
- High risk of heart failure as shown by a WATCH-DM score of 11 or higher, or elevated natriuretic peptides, or diastolic dysfunction or left ventricular hypertrophy on echocardiography
You will not qualify if you...
- eGFR less than 25
- Diagnosis of congestive heart failure
- Hyperkalemia greater than 5.0
- Contraindication to any component of the polypill
- Pregnancy
- Creatinine levels above 2.0 mg/dL in men and above 1.8 mg/dL in women
- Inability to calculate WATCH-DM score
- Inability to undergo exercise testing
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
UT Southwestern Medical Center
Dallas, Texas, United States, 75235
Actively Recruiting
Research Team
A
Ambarish Pandey, MD, MSCS
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
2
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