NCT05194111 Treating Heart Dysfunction Related to Cancer Therapy With Sacubitril/Valsartan
| NCT ID | NCT05194111 |
| Status | Recruiting |
| Phase | Phase 1, Phase 2 |
| Sponsor | Virginia Commonwealth University |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 53 participants |
| Start Date | 2022-08-11 |
| Primary Completion | 2027-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 1 is the earliest stage of human testing — safety and dosage are the primary focus. Visits are frequent and medical supervision is intensive. You will be among the first people to receive this treatment.
This trial targets 53 participants in total. It began in 2022-08-11 with a primary completion date of 2027-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
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
Contact & Investigator
Wendy Bottinor, MD
PRINCIPAL INVESTIGATOR
Virginia Commonwealth University
Frequently Asked Questions
Who can join the NCT05194111 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 120 Years, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT05194111 trial and what does that mean for participants?
Phase 1 trials are the first stage of human testing. The primary goal is to assess safety and determine appropriate dosage levels. Participants are closely monitored. These trials typically involve a small number of volunteers.
Is NCT05194111 currently recruiting?
Yes, NCT05194111 is actively recruiting participants. Contact the research team at masseycpc@vcu.edu for enrollment information.
Where is the NCT05194111 trial being conducted?
This trial is being conducted at Richmond, United States.
Who is sponsoring the NCT05194111 clinical trial?
NCT05194111 is sponsored by Virginia Commonwealth University. The principal investigator is Wendy Bottinor, MD at Virginia Commonwealth University. The trial plans to enroll 53 participants.
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