Polypill for Prevention of Cardiomyopathy

Part of paid clinical trials in Dallas, Texas.

Sponsor
University of Texas Southwestern Medical Center
Study ID
NCT06143566
Phase
PHASE1/PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 100 Years
Healthy Volunteers
Not accepted

Interventions

  • Polypill — DRUG
    A combination of finerenone 10 mg, empagliflozin 12.5 mg, and losartan 50 mg or 100 mg within a polycapsule.
  • Combined prescription of the individual medications — DRUG
    We will initiate participants on an ARB, SGLT2i, and Finerenone if they are not in the polypill arm.

Study Details

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.

Key Dates

Start date
Mar 11, 2024
Status verified
Jun 2025
Primary completion
Sep 1, 2027
Completion
Dec 1, 2027

Study Design

Enrollment
200 participants (estimated)
Allocation
RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Polypill
    Participants will take a polypill containing finerenone 10 mg, empagliflozin 12.5 mg, and losartan (25, 50 mg, or 100 mg) daily.
  • Active Comparator: Combined prescription of the individual medications
    Participants will be initiated on an SGLT2i, ARB, or finerenone if they are not already on the medication class.

Primary Outcome Measure

Oxygen uptake during peak exercise (Peak VO2) [ Time Frame: Baseline, 3-month, and 6-month ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
UT Southwestern Medical CenterDallasTexas75235
Ambarish Pandey, MD
[email protected]
214-645-9762

Find similar trials in Dallas, TX

By condition
Hypertension (high blood pressure)Type 2 diabetes
By specialty
CardiologyHeart diseaseEndocrinologyMetabolic healthWeight loss
By research site
UT Southwestern Medical Center· Dallas, TX

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