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RECRUITINGPhase 1 / Phase 2INTERVENTIONAL

Treating Heart Dysfunction Related to Cancer Therapy With Sacubitril/Valsartan

Treating Heart Dysfunction Related to Cancer Therapy With Sacubitril/Valsartan (Treat HF)

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

Who May Be Eligible (Plain English)

Who May Qualify: - 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). Who Should NOT Join This Trial: - -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 willing to sign a consent form 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 (GFR \<30 mL/min/1.73m2) - Chronic hyperkalemia (\>5mmol/L) - Evidence of 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 PFO/small ASD or small 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 NYHA classification - Allergy to valsartan or sacubitril - Inability to complete CMR or 6-minute walk test ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

Original Eligibility Criteria

View original clinical language
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 * 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). 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 (GFR \<30 mL/min/1.73m2) * Chronic hyperkalemia (\>5mmol/L) * Evidence of 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 PFO/small ASD or small 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 NYHA classification * Allergy to valsartan or sacubitril * Inability to complete 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 ACE inhibitors or ARBs, aliskiren, NSAIDs or lithium or the inability to stop these medications for the study

Treatments Being Tested

DRUG

Sacubitril-valsartan

Administered orally twice daily at a maximally tolerate dose (max dose 97mg/103mg twice daily).

DRUG

Valsartan

Administered orally twice daily at a maximally tolerate dose (max dose 160mg twice daily)

Locations (1)

Virginia Commonwealth University
Richmond, Virginia, United States