Polypill to prevent heart failure in patients with diabetes
Polypill Strategy for Prevention of Cardiomyopathy Among Patients With Diabetes at Risk of Heart Failure
This study tests if a combination pill can help people with type 2 diabetes who are at high risk for heart failure by improving their heart health and making it easier to stick to their medication.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 200 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University of Texas Southwestern Medical Center Academic / other |
| Locations | 1 site (Dallas, Texas) |
| Trial ID | NCT06143566 on ClinicalTrials.gov |
What this trial studies
This study investigates the effectiveness of a polypill strategy combining empagliflozin, losartan, and finerenone for patients with type 2 diabetes at high risk for heart failure. Participants will be randomized to receive either the polypill or usual care over a 6-month period. The primary outcome measures include changes in peak VO2 and adherence to medication. The study aims to demonstrate that a polypill can improve medication adherence and cardiovascular outcomes compared to standard treatment.
Who should consider this trial
Good fit: Ideal candidates are patients with type 2 diabetes and a high risk of heart failure, as determined by the WATCH-DM risk score.
Not a fit: Patients with severe kidney impairment, congestive heart failure, or contraindications to any component of the polypill may not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could significantly improve heart failure prevention and medication adherence in patients with type 2 diabetes.
How similar studies have performed: While the concept of a polypill for chronic conditions is gaining traction, this specific approach targeting heart failure prevention in diabetic patients is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Dallas, Texas
- UT Southwestern Medical Center — Dallas, Texas, United States (Recruiting)
Study contacts
- Principal investigator: Ambarish Pandey, MD, MSCS — UT Southwestern
- Study coordinator: Ambarish Pandey, MD, MSCS
- Email: ambarish.pandey@utsouthwestern.edu
- Phone: 214-645-2101
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.