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 |

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