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Angiotensin Receptor-Neprilysin Inhibitor

Sacubitril-Valsartan for Heart Failure (TREAT-HF Trial)

Phase 1 & 2
Recruiting
Led By Wendy Bottinor, MD
Research Sponsored by Virginia Commonwealth University
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Previous anthracycline chemotherapy
No symptoms of heart failure (shortness of breath, fatigue, swelling). Ordinary physical activity does not cause undue fatigue, palpitation, dyspnea (shortness of breath).
Must not have
Family history of genetic cardiomyopathy
Concomitant use of other ACE inhibitors or ARBs, aliskiren, NSAIDs or lithium or the inability to stop these medications for the study
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 27 months
Awards & highlights

Summary

This trial is testing a new heart failure medication in young adult cancer survivors.

Who is the study for?
Adult cancer survivors diagnosed before age 39 with stage B heart failure can join this trial. They must have had anthracycline chemo, reduced heart function but no symptoms of heart failure, and be able to perform physical activity without severe fatigue or breathlessness. Excluded are those with chronic high potassium levels, recent COVID-19 contact, certain valve issues or severe kidney disease, pregnant women, non-English/Spanish speakers who can't consent properly, and people on conflicting medications.
What is being tested?
The study is testing the effects of sacubitril-valsartan versus valsartan alone in treating heart dysfunction caused by cancer therapy. It aims to see if recruiting adult cancer survivors for this treatment is possible and how well they tolerate it.
What are the potential side effects?
Possible side effects include changes in blood pressure, kidney function problems, high potassium levels which could affect the heartbeat rhythm (hyperkalemia), dizziness due to low blood pressure (hypotension), coughing and swelling around the eyes.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I have received anthracycline chemotherapy before.
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I do not experience heart failure symptoms like shortness of breath or swelling.
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I was diagnosed with cancer at 39 years old or younger.
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My heart's pumping ability is reduced but still above 40%.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My family has a history of genetic heart muscle disease.
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I am not taking, or can stop taking, ACE inhibitors, ARBs, NSAIDs, aliskiren, or lithium for the study.
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I have severe kidney disease.
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I was diagnosed with constrictive cardiomyopathy before starting cancer treatment.
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I cannot measure my blood pressure or heart rate at home.
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I have heart disease that affects my daily activities.
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I cannot complete a heart MRI or a 6-minute walk test.
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I have not been in another study or taken experimental drugs recently.
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I had significant heart valve issues before starting cancer treatment.
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I am under 18 years old.
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I had heart valve issues before starting cancer treatment.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~27 months
This trial's timeline: 3 weeks for screening, Varies for treatment, and 27 months for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
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.
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.
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.
Secondary study objectives
Evaluate early efficacy of sacubitril-valsartan in the treatment of stage B heart failure among survivors of cancer diagnosed at or before age 39.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Arm 2: ValsartanExperimental Treatment1 Intervention
Valsartan administered orally twice daily at a maximally tolerate dose (max dose 160mg twice daily)
Group II: Arm 1: Sacubitril-valsartanExperimental Treatment1 Intervention
Sacubitril-valsartan administered orally twice daily at a maximally tolerate dose (max dose 97mg/103mg twice daily).
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Valsartan
2016
Completed Phase 4
~10560

Find a Location

Who is running the clinical trial?

Virginia Commonwealth UniversityLead Sponsor
710 Previous Clinical Trials
22,886,907 Total Patients Enrolled
25 Trials studying Heart Failure
4,772 Patients Enrolled for Heart Failure
Wendy Bottinor, MDPrincipal InvestigatorVirginia Commonwealth University

Media Library

Sacubitril-valsartan (Angiotensin Receptor-Neprilysin Inhibitor) Clinical Trial Eligibility Overview. Trial Name: NCT05194111 — Phase 1 & 2
Heart Failure Research Study Groups: Arm 1: Sacubitril-valsartan, Arm 2: Valsartan
Heart Failure Clinical Trial 2023: Sacubitril-valsartan Highlights & Side Effects. Trial Name: NCT05194111 — Phase 1 & 2
Sacubitril-valsartan (Angiotensin Receptor-Neprilysin Inhibitor) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05194111 — Phase 1 & 2
~2 spots leftby Nov 2024
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