Treating Heart Dysfunction Related to Cancer Therapy With Sacubitril/Valsartan

• Status: Not yet recruiting
• Trial end date: 2024-06-30
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Virginia Commonwealth University
• Treatments: Sacubitril and valsartan sodium hydrate drug combination; Valsartan

Criteria

Inclusion Criteria:

• Age
• 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)