Treating Heart Dysfunction Related to Cancer Therapy With Sacubitril/Valsartan (Treat HF)
Who is this study for? Patients with heart dysfunction related to cancer therapy
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 1/Phase 2
SUMMARY
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 120
Healthy Volunteers: f
View:
• Age \</= 39 years old at time of cancer diagnosis
• Clinical records adequate to determine diagnosis and treatment regimen
• Previous anthracycline chemotherapy
• Global longitudinal strain \<18% and/or
• L VEF below the institutional lower limit of normal but \>/=40% on echocardiogram or cardiac MRI
• No symptoms of heart failure (shortness of breath, fatigue, swelling). Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).
Locations
United States
Virginia
Virginia Commonwealth University
RECRUITING
Richmond
Contact Information
Primary
Massey CTO CPC Team
masseycpc@vcu.edu
804-628-6430
Time Frame
Start Date: 2022-08-11
Estimated Completion Date: 2026-11-30
Participants
Target number of participants: 53
Treatments
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)
Related Therapeutic Areas
Sponsors
Leads: Virginia Commonwealth University