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Clinical Trial Details

Trial ID: L3386
Source ID: NCT06143566
Associated Drug: Polypill
Title: Polypill for Prevention of Cardiomyopathy
Acronym: PolyPreventHF
Status: RECRUITING
Study Results: NO
Results:
Conditions: Type 2 Diabetes|High Blood Pressure
Interventions: DRUG: Polypill
Outcome Measures: Primary: Oxygen uptake during peak exercise (Peak VO2), The ability of a polypill to improve or prevent declines in exercise capacity as measured by changes in peak oxygen uptake at exercise will be assessed., Baseline, 3-month, and 6-month | Secondary: Urine albumin to creatinine ratio, The ratio of urinary albumin to creatinine will be measured., Baseline, 3 month, and 6 month | Other: Medication Adherence, Assessed via the Morisky Medication Adherence Score - 8. The score ranges from 0 to 8, with 8 meaning highest adherence., Baseline, 1 month, 3 month, and 6 month
Sponsor/Collaborators: Sponsor: University of Texas Southwestern Medical Center
Gender: ALL
Age: ADULT, OLDER_ADULT
Phases: PHASE1|PHASE2
Enrollment: 60
Study Type: INTERVENTIONAL
Study Designs: Allocation: RANDOMIZED|Intervention Model: SINGLE_GROUP|Masking: NONE|Primary Purpose: TREATMENT
Start Date: 2024-03-11
Completion Date: 2025-12-01
Results First Posted:
Last Update Posted: 2024-09-19
Locations: UT Southwestern Medical Center, Dallas, Texas, 75235, United States
URL: https://clinicaltrials.gov/show/NCT06143566