Polypill for Prevention of Cardiomyopathy (NCT06143566) | Clinical Trial Compass
RecruitingPhase 1/2
Polypill for Prevention of Cardiomyopathy
United States200 participantsStarted 2024-03-11
Plain-language 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 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 participate
Age range
18 Years – 100 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1This trial is in Phase 1/2, which means it's still in relatively early stages — what does that mean for how much is already known about whether the polypill is safe for someone with my combination of type 2 diabetes and high blood pressure?
2The trial is measuring peak oxygen uptake during exercise as its main outcome — can you help me understand what that tells us about heart health, and why it matters specifically for people with diabetes and high blood pressure who might be at risk for cardiomyopathy?
3A 'polypill' typically combines multiple medications into one — do you know which drugs are included in this combination, and are any of them ones I might already be taking, which could affect whether I'd even be eligible to discuss joining?
4Since this trial is actively recruiting, how would participating actually affect my current treatment plan — would I need to stop or adjust any of my existing diabetes or blood pressure medications?
5Before considering a trial like this, is there a standard-of-care treatment path we should try first, or do you think a study like this could be worth discussing as a next step given where my condition currently stands?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Oxygen uptake during peak exercise (Peak VO2)
Timeframe: Baseline, 3-month, and 6-month
Trial details
NCT IDNCT06143566
SponsorUniversity of Texas Southwestern Medical Center