Treating Heart Dysfunction Related to Cancer Therapy With Sacubitril/Valsartan
Part of paid clinical trials in Richmond, Virginia.
- Sponsor
- Virginia Commonwealth University
- Study ID
- NCT05194111
- Phase
- PHASE1/PHASE2
- Status
- Recruiting
Conditions
- Heart Dysfunction
- Heart Failure
Eligibility Criteria
- Sex
- ALL
- Age
- 18 Years - 120 Years
- Healthy Volunteers
- Not accepted
Interventions
- Sacubitril-valsartan — DRUGAdministered orally twice daily at a maximally tolerate dose (max dose 97mg/103mg twice daily).
- Valsartan — DRUGAdministered orally twice daily at a maximally tolerate dose (max dose 160mg twice daily)
Study Details
To determine feasibility of recruitment and tolerability of treatment with sacubitril-valsartan among adult age survivors of cancer diagnosed at or before age 39 who have stage B heart failure.
Key Dates
- Start date
- Aug 11, 2022
- Status verified
- Mar 2026
- Primary completion
- Nov 30, 2027
- Completion
- Nov 30, 2028
Study Design
- Enrollment
- 53 participants (estimated)
- Allocation
- RANDOMIZED
- Intervention model
- PARALLEL
- Primary purpose
- SUPPORTIVE_CARE
Arms
- Experimental: Arm 1: Sacubitril-valsartanSacubitril-valsartan administered orally twice daily at a maximally tolerate dose (max dose 97mg/103mg twice daily).
- Experimental: Arm 2: ValsartanValsartan administered orally twice daily at a maximally tolerate dose (max dose 160mg twice daily)
Primary Outcome Measure
Determine feasibility of recruitment to this pilot trial by evaluating the eligibility requirements among adult age survivors of cancer diagnosed at or before age 39 who have stage B heart failure. [ Time Frame: 24 Months ]
Central Contacts
- Massey CTO CPC Team804-628-6430
Locations (1)
| Facility | City | State | ZIP | Site coordinators |
|---|---|---|---|---|
| Virginia Commonwealth University | Richmond | Virginia | 23298 | Wendy Bottinor, MD (PRINCIPAL_INVESTIGATOR) |
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