Recruiting
Phase 1
Phase 2

Sacubitril-Valsartan

Sponsor:

Virginia Commonwealth University

Code:

NCT05194111

Conditions

Heart Failure

Heart Dysfunction

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Sacubitril-valsartan

Valsartan

Carvedilol

Study Details

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.

Conditions

Heart Failure

Heart Dysfunction

Study ID

NCT05194111

Start date

Aug 11, 2022

Status verified date

Jul, 2026

Completion date

Nov 30, 2028

Anticipated

Primary completion date

Nov 30, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 70+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

70 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: Arm 1: Sacubitril-valsartan

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)

experimental: Arm 3: Carvedilol

Administered orally twice daily at a maximally tolerated dose (max dose 25mg twice daily)

Interventions

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)

Carvedilol

Administered orally twice daily at a maximally tolerated dose (max dose 25mg twice daily)

Primary outcome measure

  • 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. [ Time Frame: 24 Months ]
  • 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. [ Time Frame: 27 Months ]
  • 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. [ Time Frame: 27 Months ]

Central Contacts and Locations

Central contacts

Massey CTO CPC Team

804-628-6430masseycpc@vcu.edu

Locations

Virginia Commonwealth University

Recruiting

Richmond, Virginia, United States, 23298

Contacts

Massey CTO CPC Team

804-628-6430masseycpc@vcu.edu

Principal Investigator:

Wendy Bottinor, MD

More Information

Sponsor

Virginia Commonwealth University

Last update posted

Jul 8, 2026

Last verified

Jul, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Virginia Commonwealth University on 2026-07-08.