Status:
RECRUITING
Polypill for Prevention of Cardiomyopathy
Lead Sponsor:
University of Texas Southwestern Medical Center
Conditions:
Type 2 Diabetes
High Blood Pressure
Eligibility:
All Genders
18-100 years
Phase:
PHASE1
PHASE2
Brief 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 t...
Detailed Description
Heart failure (HF) is a major cause of cardiovascular morbidity and mortality. One of the risk factors for HF is diabetes mellitus (DM). Altered glucose and lipid metabolism in DM leads to fibrosis an...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
March 11 2024
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT06143566
Start Date
March 11 2024
End Date
December 1 2027
Last Update
June 17 2025
Active Locations (1)
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1
UT Southwestern Medical Center
Dallas, Texas, United States, 75235