RECRUITING

Treating Heart Dysfunction Related to Cancer Therapy With Sacubitril/Valsartan

Conditions

Quick Navigation

Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2022-08-11

Study Completion:2024-11-30

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT05194111

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 120 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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).	* -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

Inclusion Criteria

Exclusion 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).

* -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

Contacts and Locations

Study Contact

Massey Cancer Control DWG

CONTACT

804-628-4916

masseycpc@vcu.edu

Massey CTO Operations Managers

CONTACT

ctoclinops@vcu.edu

Principal Investigator

Wendy Bottinor, MD

PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Study Locations (Sites)

Virginia Commonwealth University

Richmond, Virginia, 23298

United States

Collaborators and Investigators

Sponsor: Virginia Commonwealth University

Wendy Bottinor, MD, PRINCIPAL_INVESTIGATOR, Virginia Commonwealth University

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2022-08-11

Study Completion Date2024-11-30

Study Record Updates

Study Start Date2022-08-11

Study Completion Date2024-11-30

Terms related to this study

Additional Relevant MeSH Terms

Heart Failure
Heart Dysfunction