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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

No Placebo-Only Group

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 weeks3 visits

Treatment ~ Varies

Follow Up ~ 27 months

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.