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Sacubitril/Valsartan for Heart Dysfunction After Cancer Therapy

This study is looking at sacubitril-valsartan, a medication, for heart dysfunction (Stage B heart failure) in adults who had cancer before age 39. Researchers want to see if it's possible to recruit enough participants and if the treatment is well-tolerated. You might be able to join if you were diagnosed with cancer at or before age 39, received certain chemotherapy, and have specific heart measurements. The study is comparing sacubitril-valsartan to valsartan and carvedilol. The main goal is to understand how practical it is to run this study and how well people tolerate the treatment over 24 to 27 months. The current status of this study is unclear.

Study design
This interventional study plans to enroll 70 participants. It is testing sacubitril-valsartan against valsartan and carvedilol.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for 24 to 27 months to assess recruitment feasibility and treatment tolerability.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT05194111

Treating Heart Dysfunction Related to Cancer Therapy With Sacubitril/Valsartan

Recruiting
PHASE1Ages 18+InterventionalSupportive care
Virginia Commonwealth University
~70 participants
Updated 2026-07-08 on ClinicalTrials.gov
What's tested:Sacubitril-valsartanValsartanCarvedilol

At a glance

Recruiting sites
1 of 1 listed site is recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Determine feasibility of recruitment to this pilot trial by evaluating the eligibility requirements among adult age survivors of cancer diagnosed at or before age 39 who have stage B heart failure.
Measured over 24 Months
+2 more outcomes measured

Conditions

Heart Failure
Heart Dysfunction

Explore related trials

Heart Failure

NCT05194111

Where you'd take part

This study runs at 1 site. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • Virginia Commonwealth University

    Richmond, Virginiastudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Study leadership

  • Wendy Bottinor, MD · PRINCIPAL_INVESTIGATOR · Virginia Commonwealth University

Who to contact

Massey CTO CPC Team
[email protected]
804-628-6430
Email the study team

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Eligibility criteria

Inclusion

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

-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

What this trial measures

  • Determine feasibility of recruitment to this pilot trial by evaluating the eligibility requirements among adult age survivors of cancer diagnosed at or before age 39 who have stage B heart failure.24 Months

    Number of participants screened for the clinical trial.

  • Determine the feasibility of recruitment to this pilot trial by evaluating the eligibility requirements among adult age survivors of cancer diagnosed at or before age 39 who have stage B heart failure.27 Months

    Number of participants enrolled on the trial

  • Determine tolerability of treatment with sacubitril-valsartan among adult age survivors of cancer diagnosed at or before age 39 who have stage B heart failure.27 Months

    Number of participants that complete therapy