Treating heart dysfunction in cancer survivors with a specific medication
Treating Heart Dysfunction Related to Cancer Therapy With Sacubitril/Valsartan (Treat HF)
This study is testing if a heart medication called sacubitril-valsartan is safe and helpful for adult cancer survivors under 39 who have early signs of heart failure but no symptoms.
Quick facts
| Phase | Phase1; Phase2 |
|---|---|
| Study type | Interventional |
| Enrollment | 53 (estimated) |
| Ages | 18 Years to 120 Years |
| Sex | All |
| Sponsor | Virginia Commonwealth University Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 1 site (Richmond, Virginia) |
| Trial ID | NCT05194111 on ClinicalTrials.gov |
What this trial studies
This study aims to evaluate the feasibility and safety of using sacubitril-valsartan to treat Stage B heart failure in adult survivors of cancer diagnosed before the age of 39. Participants will be assessed for their eligibility based on their cancer treatment history and heart function metrics. The study will focus on individuals who have previously received anthracycline chemotherapy and exhibit specific heart function parameters without showing symptoms of heart failure. The goal is to determine if this treatment can be safely administered to this unique patient population.
Who should consider this trial
Good fit: Ideal candidates are adult survivors of cancer diagnosed at or before age 39 who have Stage B heart failure and a history of anthracycline chemotherapy.
Not a fit: Patients under 18 years old or those with active psychiatric illnesses may not benefit from this study.
Why it matters
Potential benefit: If successful, this treatment could improve heart function and quality of life for young cancer survivors experiencing heart dysfunction.
How similar studies have performed: While this approach is novel for this specific population, similar studies have shown promise in treating heart dysfunction with sacubitril-valsartan in other heart failure contexts.
Eligibility criteria
Show full inclusion / exclusion 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
Where this trial is running
Richmond, Virginia
- Virginia Commonwealth University — Richmond, Virginia, United States (Recruiting)
Study contacts
- Principal investigator: Wendy Bottinor, MD — Virginia Commonwealth University
- Study coordinator: Massey CTO CPC Team
- Email: masseycpc@vcu.edu
- Phone: 804-628-6430
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.