Heart Dysfunction, Heart Failure
Conditions
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.
Interventions
DRUGSacubitril-valsartan
Administered orally twice daily at a maximally tolerate dose (max dose 97mg/103mg twice daily).
DRUGValsartan
Administered orally twice daily at a maximally tolerate dose (max dose 160mg twice daily)
DRUGCarvedilol
Administered orally twice daily at a maximally tolerated dose (max dose 25mg twice daily)
Sponsors
Virginia Commonwealth University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (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
Eligibility
Sex/Gender
ALL
Age
18 Years to 120 Years
Healthy volunteers
No
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 * Left ventricular ejection fraction (LVEF) below the institutional lower limit of normal but \>/=40% on echocardiogram or cardiac magnetic resonance imaging (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 (glomerular filtration rate (GFR) \<30 milliliters (mL)/minute (min)/1.73 meters squared (m2)) * Chronic hyperkalemia (\>5millimoles per liter (mmol/L)) * Evidence of Coronavirus (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 patent foramen ovale (PFO)/small atrial septal defect (ASD) or small ventricular septal defect (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 New York Heart Association (NYHA) classification * Allergy to valsartan or sacubitril * Inability to complete cardiac magnetic resonance (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 angiotensin-converting enzyme (ACE) inhibitors or angiotensin II receptor blockers (ARBs), aliskiren, non-steroidal anti-inflammatories (NSAIDs) or lithium or the inability to stop these medications for the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
United States
Contacts
CONTACTMassey CTO CPC Team
PRINCIPAL_INVESTIGATORWendy Bottinor, MD
Virginia Commonwealth University
Outcome results
None listed