Can a heart pill protect cancer Survivors' hearts?
NCT ID NCT05194111
First seen Jun 27, 2026 · Last updated Jul 09, 2026 · Updated 2 times
Summary
This study tests a drug called sacubitril-valsartan in young adult cancer survivors (diagnosed at or before age 39) who have early-stage heart failure (stage B) caused by past chemotherapy. The goal is to see if the drug is tolerable and can help control heart damage. About 53 participants will take the medication and be monitored for side effects and heart function.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 1/2
Runs two stages together: safety and dose first, then whether the treatment works.
- Participants
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Aug 2022
- Expected to finish
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Nov 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 120 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
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
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Virginia Commonwealth University
RECRUITINGRichmond, Virginia, 23298, United States
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