Polypill for Prevention of Cardiomyopathy

Launched by UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER · Nov 16, 2023

Keywords

ClinConnect Summary

This clinical trial is studying whether a special combination of medications, known as a polypill, can help prevent heart problems in people with type 2 diabetes and high blood pressure. The polypill includes three medicines: empagliflozin, losartan, and finerenone. Researchers will compare the effects of this polypill to standard care over a period of six months. The main goal is to see if using the polypill helps patients improve their exercise capacity and stick to their medication plan better than those receiving standard care.

To be eligible for this trial, participants need to be between the ages of 65 and 74 and have type 2 diabetes with specific kidney function measurements. They should also have a high risk of heart failure, which can be determined through a scoring system called the WATCH-DM score or by other tests. Throughout the study, participants will be monitored closely, and they may need to undergo some exercise testing. This trial is currently seeking volunteers, so if you or someone you know fits these criteria, it might be an opportunity to contribute to important research while receiving potential benefits for heart health.

Gender

ALL

Eligibility criteria

• 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