Sacubitril/Valsartan for the Treatment of Cancer Therapy Related Heart Dysfunction, TREAT HF Trial

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 mL/min/1.73m ^ 2).
• 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 patent foramen ovale closure (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 imaging (CMR).
• 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