NCT05194111 · Virginia Commonwealth University
Treating Heart Dysfunction Related to Cancer Therapy With Sacubitril/Valsartan
(TREAT-HF)
What this study is about
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.
View original scientific description
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 can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
Where
- Richmond, Virginia
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Jul 8, 2026 · Source of record for eligibility and locations