Back to resultsTreating Heart Dysfunction Related to Cancer Therapy With Sacubitril/Valsartan (TREAT-HF)
Primary Purpose
Heart Failure, Heart Dysfunction
Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
Sacubitril-valsartan
Valsartan
Sponsored by
About this trial
This is an interventional supportive care trial for Heart Failure
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
Sites / Locations
- Virginia Commonwealth UniversityRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Experimental
Arm Label
Arm 1: Sacubitril-valsartan
Arm 2: Valsartan
Arm Description
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)
Outcomes
Primary Outcome Measures
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.
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
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
Secondary Outcome Measures
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
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
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
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
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
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
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.
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.
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.
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.
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.
Full Information
NCT ID
NCT05194111
First Posted
January 3, 2022
Last Updated
May 8, 2023
Sponsor
Virginia Commonwealth University
1. Study Identification
Unique Protocol Identification Number
NCT05194111
Brief Title
Treating Heart Dysfunction Related to Cancer Therapy With Sacubitril/Valsartan
Acronym
TREAT-HF
Official Title
Treating Heart Dysfunction Related to Cancer Therapy With Sacubitril/Valsartan (Treat HF)
Study Type
Interventional
2. Study Status
Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
March 9, 2022 (Actual)
Primary Completion Date
June 30, 2024 (Anticipated)
Study Completion Date
June 30, 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Virginia Commonwealth University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Heart Failure, Heart Dysfunction
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Masking Description
Cardiac magnetic resonance studies will be de-identified and assigned a study number. The identification key will not be available to cardiac magnetic resonance readers so that they are blinded to treatment allocation
Allocation
Randomized
Enrollment
30 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Arm 1: Sacubitril-valsartan
Arm Type
Experimental
Arm Description
Sacubitril-valsartan administered orally twice daily at a maximally tolerate dose (max dose 97mg/103mg twice daily).
Arm Title
Arm 2: Valsartan
Arm Type
Experimental
Arm Description
Valsartan administered orally twice daily at a maximally tolerate dose (max dose 160mg twice daily)
Intervention Type
Drug
Intervention Name(s)
Sacubitril-valsartan
Intervention Description
Administered orally twice daily at a maximally tolerate dose (max dose 97mg/103mg twice daily).
Intervention Type
Drug
Intervention Name(s)
Valsartan
Intervention Description
Administered orally twice daily at a maximally tolerate dose (max dose 160mg twice daily)
Primary Outcome Measure Information:
Title
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.
Description
Number of participants screened for the clinical trial.
Time Frame
24 Months
Title
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.
Description
Number of participants enrolled on the trial
Time Frame
27 Months
Title
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.
Description
Number of participants that complete therapy
Time Frame
27 Months
Secondary Outcome Measure Information:
Title
Evaluate early efficacy of sacubitril-valsartan in the treatment of stage B heart failure among survivors of cancer diagnosed at or before age 39.
Description
Number of deaths while on study due to cardiac event
Time Frame
27 Months
Title
Evaluate early efficacy of sacubitril-valsartan in the treatment of stage B heart failure among survivors of cancer diagnosed at or before age 39.
Description
Number of deaths while on study due to non-cardiac events
Time Frame
90 Days
Title
Evaluate early efficacy of sacubitril-valsartan in the treatment of stage B heart failure among survivors of cancer diagnosed at or before age 39.
Description
By the number of Adverse events at 30 days
Time Frame
30 Days
Title
Evaluate early efficacy of sacubitril-valsartan in the treatment of stage B heart failure among survivors of cancer diagnosed at or before age 39.
Description
By the number of Adverse events at 60 days
Time Frame
60 Days
Title
Evaluate early efficacy of sacubitril-valsartan in the treatment of stage B heart failure among survivors of cancer diagnosed at or before age 39.
Description
By the number of Adverse events at 90 days
Time Frame
90 Days
Title
Evaluate early efficacy of sacubitril-valsartan in the treatment of stage B heart failure among survivors of cancer diagnosed at or before age 39.
Description
By determining number of participants with interval change utilizing a 6-minute walk test distance
Time Frame
90 Days
Title
Evaluate early efficacy of sacubitril-valsartan in the treatment of stage B heart failure among survivors of cancer diagnosed at or before age 39.
Description
By number of participants with cardiovascular magnetic resonance imaging assessment change in cardiac fibrosis burden.
Time Frame
90 Days
Title
Evaluate early efficacy of sacubitril-valsartan in the treatment of stage B heart failure among survivors of cancer diagnosed at or before age 39.
Description
By number of participants with cardiovascular magnetic resonance imaging assessment change in microvascular perfusion.
Time Frame
90 Days
Title
Evaluate early efficacy of sacubitril-valsartan in the treatment of stage B heart failure among survivors of cancer diagnosed at or before age 39.
Description
By number of participants with cardiovascular magnetic resonance imaging assessment change in arterial stiffness/4D flow.
Time Frame
90 Days
Title
Evaluate early efficacy of sacubitril-valsartan in the treatment of stage B heart failure among survivors of cancer diagnosed at or before age 39.
Description
By number of participants with cardiovascular magnetic resonance imaging assessment change in left ventricular ejection fraction.
Time Frame
90 Days
Title
Evaluate early efficacy of sacubitril-valsartan in the treatment of stage B heart failure among survivors of cancer diagnosed at or before age 39.
Description
By number of participants with cardiovascular magnetic resonance imaging assessment change in change in left ventricular strain.
Time Frame
90 Days
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
120 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Massey Cancer Control DWG
Phone
804-628-4916
Email
masseycpc@vcu.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Massey CTO Operations Managers
Email
ctoclinops@vcu.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Wendy Bottinor, MD
Organizational Affiliation
Virginia Commonwealth University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Virginia Commonwealth University
City
Richmond
State/Province
Virginia
ZIP/Postal Code
23298
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Massey CPC DWG
Phone
804-628-4916
Email
masseycpc@vcu.edu
First Name & Middle Initial & Last Name & Degree
Massey CTO Operations Managers
Email
ctoclinops@vcu.edu
First Name & Middle Initial & Last Name & Degree
Wendy Bottinor, MD
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
There are no plans to make individual participant data available to other researchers at this time.
Learn more about this trial
Treating Heart Dysfunction Related to Cancer Therapy With Sacubitril/Valsartan
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