Treating Heart Dysfunction Related to Cancer Therapy With Sacubitril/Valsartan

Heart Failure Clinical Trial

— TREAT-HF  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05194111
• Other study ID #: MCC-21-18830
• Secondary ID: HM20023601
• Status: Recruiting
• Phase: Phase 1/Phase 2
• Start date: August 11, 2022
• Est. completion date: June 30, 2024

Study information

• Verified date: January 2024
• Source: Virginia Commonwealth University
• Contact: Massey Cancer Control DWG
• Phone: 804-628-4916
• Email: masseycpc[@]vcu.edu
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 30, 2024
• Est. primary completion date: June 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 120 Years

Eligibility

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

Related Conditions & MeSH terms

• Heart Failure

Intervention

Drug:
• Sacubitril-valsartan
Administered orally twice daily at a maximally tolerate dose (max dose 97mg/103mg twice daily).
• Valsartan
Administered orally twice daily at a maximally tolerate dose (max dose 160mg twice daily)

Locations

Country	Name	City	State
United States	Virginia Commonwealth University	Richmond	Virginia

Sponsors (1)

Lead Sponsor	Collaborator
Virginia Commonwealth University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Determine feasibility of recruitment to this pilot trial by evaluating the eligibility requirements among adult age survivors of cancer diagnosed at or before age 39 who have stage B heart failure.	Number of participants screened for the clinical trial.	24 Months
Primary	Determine the feasibility of recruitment to this pilot trial by evaluating the eligibility requirements among adult age survivors of cancer diagnosed at or before age 39 who have stage B heart failure.	Number of participants enrolled on the trial	27 Months
Primary	Determine tolerability of treatment with sacubitril-valsartan among adult age survivors of cancer diagnosed at or before age 39 who have stage B heart failure.	Number of participants that complete therapy	27 Months
Secondary	Evaluate early efficacy of sacubitril-valsartan in the treatment of stage B heart failure among survivors of cancer diagnosed at or before age 39.	Number of deaths while on study due to cardiac event	27 Months
Secondary	Evaluate early efficacy of sacubitril-valsartan in the treatment of stage B heart failure among survivors of cancer diagnosed at or before age 39.	Number of deaths while on study due to non-cardiac events	90 Days
Secondary	Evaluate early efficacy of sacubitril-valsartan in the treatment of stage B heart failure among survivors of cancer diagnosed at or before age 39.	By the number of Adverse events at 30 days	30 Days
Secondary	Evaluate early efficacy of sacubitril-valsartan in the treatment of stage B heart failure among survivors of cancer diagnosed at or before age 39.	By the number of Adverse events at 60 days	60 Days
Secondary	Evaluate early efficacy of sacubitril-valsartan in the treatment of stage B heart failure among survivors of cancer diagnosed at or before age 39.	By the number of Adverse events at 90 days	90 Days
Secondary	Evaluate early efficacy of sacubitril-valsartan in the treatment of stage B heart failure among survivors of cancer diagnosed at or before age 39.	By determining number of participants with interval change utilizing a 6-minute walk test distance	90 Days
Secondary	Evaluate early efficacy of sacubitril-valsartan in the treatment of stage B heart failure among survivors of cancer diagnosed at or before age 39.	By number of participants with cardiovascular magnetic resonance imaging assessment change in cardiac fibrosis burden.	90 Days
Secondary	Evaluate early efficacy of sacubitril-valsartan in the treatment of stage B heart failure among survivors of cancer diagnosed at or before age 39.	By number of participants with cardiovascular magnetic resonance imaging assessment change in microvascular perfusion.	90 Days
Secondary	Evaluate early efficacy of sacubitril-valsartan in the treatment of stage B heart failure among survivors of cancer diagnosed at or before age 39.	By number of participants with cardiovascular magnetic resonance imaging assessment change in arterial stiffness/4D flow.	90 Days
Secondary	Evaluate early efficacy of sacubitril-valsartan in the treatment of stage B heart failure among survivors of cancer diagnosed at or before age 39.	By number of participants with cardiovascular magnetic resonance imaging assessment change in left ventricular ejection fraction.	90 Days
Secondary	Evaluate early efficacy of sacubitril-valsartan in the treatment of stage B heart failure among survivors of cancer diagnosed at or before age 39.	By number of participants with cardiovascular magnetic resonance imaging assessment change in change in left ventricular strain.	90 Days