Treating Heart Dysfunction Related to Cancer Therapy With Sacubitril/Valsartan (TREAT-HF)

  • STATUS
    Recruiting
  • End date
    Jun 30, 2024
  • participants needed
    30
  • sponsor
    Virginia Commonwealth University
Updated on 23 May 2022
cancer
heart failure
dyspnea
cardiac mri
valsartan

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.

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.

Details
Condition Heart Failure, Heart Dysfunction
Treatment Valsartan, Sacubitril-Valsartan
Clinical Study IdentifierNCT05194111
SponsorVirginia Commonwealth University
Last Modified on23 May 2022

Eligibility

Yes No Not Sure

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
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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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