Polypill for Prevention of Cardiomyopathy
About this study
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.
- Condition
- Type 2 Diabetes, High Blood Pressure
- Tested
- Polypill, Combined prescription of the individual medications
- Sponsor
- University of Texas Southwestern Medical Center
Who can join
- Age
- 18 to 100 years
- Sex
- All sexes
- Healthy volunteers
- Not accepted
Inclusion 6
- Minimum age: 18 years
- Maximum age: 100 years
- Study condition: Type 2 Diabetes, High Blood Pressure
- 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 8
- 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
1 site, 1 recruiting
UT Southwestern Medical Center
Dallas, Texas, United States
Contact
-
Ambarish Pandey, MD, MSCS
214-645-2101 ambarish.pandey@utsouthwestern.edu
Potential match only. Final eligibility is determined by the study team.