TREAT-HF: Treating Heart Dysfunction Related to Cancer Therapy With Sacubitril/Valsartan
Study Details
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.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
| Phase 1/Phase 2 |
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.
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: Arm 1: Sacubitril-valsartan Sacubitril-valsartan administered orally twice daily at a maximally tolerate dose (max dose 97mg/103mg twice daily). |
Drug: Sacubitril-valsartan
Administered orally twice daily at a maximally tolerate dose (max dose 97mg/103mg twice daily).
|
| Experimental: Arm 2: Valsartan Valsartan administered orally twice daily at a maximally tolerate dose (max dose 160mg twice daily) |
Drug: Valsartan
Administered orally twice daily at a maximally tolerate dose (max dose 160mg twice daily)
|
Outcome Measures
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. [24 Months]
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. [27 Months]
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. [27 Months]
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. [27 Months]
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. [90 Days]
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. [30 Days]
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. [60 Days]
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. [90 Days]
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. [90 Days]
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. [90 Days]
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. [90 Days]
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. [90 Days]
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. [90 Days]
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. [90 Days]
By number of participants with cardiovascular magnetic resonance imaging assessment change in change in left ventricular strain.
Eligibility Criteria
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
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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
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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
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Participation in another concurrent intervention study within 30 days or treatment with an investigational drug within 5 half-lives prior to randomization
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Greater than mild mitral or aortic valve regurgitation/stenosis known pre-cancer therapy
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Severe kidney disease (GFR <30 mL/min/1.73m2)
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Chronic hyperkalemia (>5mmol/L)
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Evidence of COVID-19 within the last 60 days or recent (21 days) exposure to close personal contact with COVID-19.
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Greater than moderate tricuspid or pulmonary valve regurgitation/stenosis known pre-cancer therapy
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Hemodynamically significant congenital heart disease in the opinion of the investigator (not including PFO/small ASD or small VSD)
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Greater than moderate pericardial effusion
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Constrictive cardiomyopathy diagnosed pre-cancer therapy
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Family history of genetic cardiomyopathy
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Evidence of infiltrative cardiomyopathy
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Symptomatic heart disease based on NYHA classification
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Allergy to valsartan or sacubitril
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Inability to complete CMR or 6-minute walk test
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Inability to measure non-invasive blood pressure and heart rate in the ambulatory/home setting
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Pregnant/lactating
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History of severe hypersensitivity reactions to gadolinium-based contrast agents (will perform limited cardiac imaging without contrast)
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Concomitant use of other ACE inhibitors or ARBs, aliskiren, NSAIDs or lithium or the inability to stop these medications for the study
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Virginia Commonwealth University | Richmond | Virginia | United States | 23298 |
Sponsors and Collaborators
- Virginia Commonwealth University
Investigators
- Principal Investigator: Wendy Bottinor, MD, Virginia Commonwealth University
Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- MCC-21-18830
- HM20023601