Polypill for Prevention of Cardiomyopathy

• Status: Recruiting
• Trial end date: 2024-12-01
• Target enrollment: 0
• Participant gender: All

Summary

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 50 or 100 mg, and finerenone 10 mg daily. The study duration is 3 months, and participants will be randomized to either polypill therapy or usual care. 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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Texas Southwestern Medical Center
• Treatments: Empagliflozin; Losartan

Criteria

Inclusion Criteria:

• Patients with Type 2 DM and urinary albumin-to-creatinine ratio (with albumin measured in milligrams and creatinine measured in grams) of 30 to less than 300 and an estimated glomerular filtration rate (eGFR) of 25 to 90 ml per minute per 1.73 m2 of body-surface area (stage 2 to 4 CKD) 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