Status:
RECRUITING
Treating Heart Dysfunction Related to Cancer Therapy With Sacubitril/Valsartan
Lead Sponsor:
Virginia Commonwealth University
Conditions:
Heart Failure
Heart Dysfunction
Eligibility:
All Genders
18-120 years
Phase:
PHASE1
PHASE2
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.
Detailed Description
The current study will test the hypothesis that among adult age survivors of cancer diagnosed at age \< 39 years treatment of Stage B heart failure with sacubitril-valsartan is feasible and safe.
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
- 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
- -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
Key Trial Info
Start Date :
August 11 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
November 30 2026
Estimated Enrollment :
53 Patients enrolled
Trial Details
Trial ID
NCT05194111
Start Date
August 11 2022
End Date
November 30 2026
Last Update
September 22 2025
Active Locations (1)
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1
Virginia Commonwealth University
Richmond, Virginia, United States, 23298