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

Eligibility Criteria

Sex
ALL
Age
18 Years - 120 Years
Healthy Volunteers
Not accepted

Interventions

  • Sacubitril-valsartan — DRUG
    Administered orally twice daily at a maximally tolerate dose (max dose 97mg/103mg twice daily).
  • Valsartan — DRUG
    Administered 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-valsartan
    Sacubitril-valsartan administered orally twice daily at a maximally tolerate dose (max dose 97mg/103mg twice daily).
  • Experimental: Arm 2: Valsartan
    Valsartan 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

Locations (1)

FacilityCityStateZIPSite coordinators
Virginia Commonwealth UniversityRichmondVirginia23298
Massey CTO CPC Team
804-628-6430
Wendy Bottinor, MD (PRINCIPAL_INVESTIGATOR)

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