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

Virginia Commonwealth University (VCU)

Status and phase: Enrolling; Phase 2; Phase 1

Conditions: Heart Dysfunction; Heart Failure

Treatments: Drug: Sacubitril-valsartan; Drug: Valsartan

Study type: Interventional

Funder types: Other

Identifiers

NCT05194111

MCC-21-18830

HM20023601 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Enrollment: 53 estimated patients

Sex: All

Ages: 18 to 120 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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53 participants in 2 patient groups

Arm 1: Sacubitril-valsartan

Experimental group

Description:

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

Treatment:

Drug: Sacubitril-valsartan

Arm 2: Valsartan

Experimental group

Description:

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

Treatment:

Drug: Valsartan