Treating Heart Dysfunction Related to Cancer Therapy With Sacubitril/Valsartan

NCT ID: NCT05194111

Last Updated: 2025-09-22

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 53 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-08-11
• Study Completion Date: 2026-11-30

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.

Conditions

Heart Failure; Heart Dysfunction

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Arm 1: Sacubitril-valsartan

Sacubitril-valsartan administered orally twice daily at a maximally tolerate dose (max dose 97mg/103mg twice daily).

Group Type: EXPERIMENTAL

Sacubitril-valsartan

Intervention Type: DRUG

Administered orally twice daily at a maximally tolerate dose (max dose 97mg/103mg twice daily).

Arm 2: Valsartan

Valsartan administered orally twice daily at a maximally tolerate dose (max dose 160mg twice daily)

Group Type: EXPERIMENTAL

Valsartan

Intervention Type: DRUG

Administered orally twice daily at a maximally tolerate dose (max dose 160mg twice daily)

Interventions

Sacubitril-valsartan

Administered orally twice daily at a maximally tolerate dose (max dose 97mg/103mg twice daily).

Intervention Type: DRUG

Valsartan

Administered orally twice daily at a maximally tolerate dose (max dose 160mg twice daily)

Intervention Type: DRUG

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 120 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Virginia Commonwealth University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Wendy Bottinor, MD

Role: PRINCIPAL_INVESTIGATOR

Virginia Commonwealth University

Locations

Virginia Commonwealth University

Richmond, Virginia, United States

Site Status: RECRUITING

Countries

United States

Central Contacts

Massey CTO CPC Team

Role: CONTACT

masseycpc@vcu.edu

804-628-6430

Facility Contacts

Massey CTO CPC Team

Role: primary

masseycpc@vcu.edu

804-628-6430

Other Identifiers

HM20023601

Identifier Type: OTHER

Identifier Source: secondary_id

MCC-21-18830

Identifier Type: -

Identifier Source: org_study_id