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Treating Heart Dysfunction Related to Cancer Therapy With Sacubitril/Valsartan
RecruitingPhase 1/2
Treating Heart Dysfunction Related to Cancer Therapy With Sacubitril/Valsartan (Treat HF)
Who can join
Ages 18 to 120 · All sexes
Full eligibility criteria
Inclusion Criteria: * 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 * Left ventricular ejection fraction (LVEF) below the institutional lower limit of normal but \>/=40% on echocardiogram or cardiac magnetic resonance imaging (MRI) * No symptoms of heart failure (shortness of breath, fatigue, swelling). Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath). Exclusion Criteria: * -Age \<18 years * Inability to obtain consent from patient or legally authorized representative * Active acute or chronic psychiatric illness that in the opinion of the investigator may prevent compliance with study instructions * Limited English or Spanish proficiency that in the opinion of the investigator may prevent understanding the content of the informed consent form or safely completing the study procedures * Participation in another concurrent intervention study within 30 days or treatment with an investigational drug within 5 half-lives prior to randomization * Greater than mild mitral or aortic valve regurgitation/stenosis known pre-cancer therapy * Severe kidney disease (glomerular filtration rate (GFR) \<30 milliliters (mL)/minute (min)/1.73 meters squared (m2)) * Chronic hyperkalemia (\>5millimoles per liter (mmol/L)) * Evidence of Coronavirus (COVID-19) within the last 60 days or recent (21 days) exposure to close personal contact with COVID-19. * Greater than moderate tricuspid or pulmonary valve regurgitation/stenosis known pre-cancer therapy * Hemodynamically significant congenital heart disease in the opinion of the investigator (not including patent foramen ovale (PFO)/small atrial septal defect (ASD) or small ventricular septal defect (VSD)) * Greater than moderate pericardial effusion * Constrictive cardiomyopathy diagnosed pre-cancer therapy * Family history of genetic cardiomyopathy * Evidence of infiltrative cardiomyopathy * Symptomatic heart disease based on New York Heart Association (NYHA) classification * Allergy to valsartan or sacubitril * Inability to complete cardiac magnetic resonance (CMR) or 6-minute walk test * Inability to measure non-invasive blood pressure and heart rate in the ambulatory/home setting * Pregnant/lactating * History of severe hypersensitivity reactions to gadolinium-based contrast agents (will perform limited cardiac imaging without contrast) * Concomitant use of other angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs), aliskiren, non-steroidal anti-inflammatories (NSAIDs) or lithium or the inability to stop these medications for the study
About the study
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.
What is being tested
- Sacubitril-valsartan (drug)
- Valsartan (drug)
- Carvedilol (drug)
Sponsor: Virginia Commonwealth University · Participants: 70 · Started: Aug 11, 2022
Contact the study team
- Massey CTO CPC Team · Phone: 804-628-6430
Official record on ClinicalTrials.gov — NCT05194111
Locations in the U.S.
| Virginia | Virginia Commonwealth University, Richmond |
Conditions
From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.