Polypill for Prevention of Cardiomyopathy
Recruiting · NCT06143566 · Interventional (participants receive a specific treatment) · Lead sponsor: University of Texas Southwestern Medical Center
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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 is running
1 location listed across 1 US state.
- UT Southwestern Medical Center - Dallas, Texas, United States