Treating Heart Dysfunction Related to Cancer Therapy With Sacubitril/Valsartan

NCT05194111 | Recruiting Phase 1 DMC FDA Drug

• 2 other identifiers: MCC-21-18830HM20023601
• Study Type: interventional
• Target: 53
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  Number of participants enrolled on the trial

  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.

  Number of participants that complete therapy

  27 Months

Secondary Outcomes (11)

• 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

• 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

• 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

• 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

• 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

Study Arms (2)

Arm 1: Sacubitril-valsartan

EXPERIMENTAL

Sacubitril-valsartan administered orally twice daily at a maximally tolerate dose (max dose 97mg/103mg twice daily).

Drug: Sacubitril-valsartan

Arm 2: Valsartan

EXPERIMENTAL

Valsartan administered orally twice daily at a maximally tolerate dose (max dose 160mg twice daily)

Drug: Valsartan

Interventions

Sacubitril-valsartan DRUG

Administered orally twice daily at a maximally tolerate dose (max dose 97mg/103mg twice daily).

Arm 1: Sacubitril-valsartan

Valsartan DRUG

Administered orally twice daily at a maximally tolerate dose (max dose 160mg twice daily)

Arm 2: Valsartan

Eligibility Criteria

• Age: 18 Years - 120 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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).

You may not qualify if:

• 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

Sponsors & Collaborators

• Virginia Commonwealth University: lead

Study Sites (1)

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

RECRUITING

MeSH Terms

Conditions

Heart Failure

Interventions

sacubitril and valsartan sodium hydrate drug combination; Valsartan

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Tetrazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Valine; Amino Acids, Branched-Chain; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Essential

Study Officials

• Wendy Bottinor, MD

  Virginia Commonwealth University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Massey CTO CPC Team

CONTACT

804-628-6430; masseycpc@vcu.edu

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: 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
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 3, 2022
• First Posted: January 18, 2022
• Study Start: August 11, 2022
• Primary Completion (Estimated): November 30, 2027
• Study Completion (Estimated): November 30, 2028
• Last Updated: March 13, 2026

Record last verified: 2026-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)