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Polypill for Prevention of Cardiomyopathy
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.
Conditions:
🦠 Type 2 Diabetes 🦠 High Blood Pressure
🗓️ Study Start (Actual) 11 March 2024
🗓️ Primary Completion (Estimated) 1 September 2024
✅ Study Completion (Estimated) 1 December 2024
👥 Enrollment (Estimated) 60
🔬 Study Type INTERVENTIONAL
📊 Phase PHASE1
Locations:
📍 Dallas, Texas, United States

📋 Eligibility Criteria

Description

    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
Ages Eligible for Study: 18 Years to 100 Years (ADULT, OLDER_ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 16 November 2023
  • First Submitted that Met QC Criteria 16 November 2023
  • First Posted 22 November 2023

Study Record Updates

  • Last Update Submitted that Met QC Criteria 11 March 2024
  • Last Update Posted 12 March 2024
  • Last Verified March 2024
I'm interested ...!!