Polypill to prevent heart failure in patients with diabetes

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.