NCT06143566 Polypill for Prevention of Cardiomyopathy
| NCT ID | NCT06143566 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | University of Texas Southwestern Medical Center |
| Condition | Type 2 Diabetes |
| Study Type | INTERVENTIONAL |
| Enrollment | 200 participants |
| Start Date | 2024-03-11 |
| Primary Completion | 2027-09-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 200 participants in total. It began in 2024-03-11 with a primary completion date of 2027-09-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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 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.
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
Contact & Investigator
Ambarish Pandey, MD, MSCS
PRINCIPAL INVESTIGATOR
UT Southwestern
Frequently Asked Questions
Who can join the NCT06143566 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 100 Years, studying Type 2 Diabetes. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06143566 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT06143566 currently recruiting?
Yes, NCT06143566 is actively recruiting participants. Contact the research team at ambarish.pandey@utsouthwestern.edu for enrollment information.
Where is the NCT06143566 trial being conducted?
This trial is being conducted at Dallas, United States.
Who is sponsoring the NCT06143566 clinical trial?
NCT06143566 is sponsored by University of Texas Southwestern Medical Center. The principal investigator is Ambarish Pandey, MD, MSCS at UT Southwestern. The trial plans to enroll 200 participants.
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