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Heart shield for chemo: new trial aims to protect AML patients

NCT ID NCT04977180

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether giving two common heart medications (a beta blocker and an ACE inhibitor) before and during intensive chemotherapy can prevent heart damage in people newly diagnosed with acute myeloid leukemia (AML). About 70 adults will be randomly assigned to receive the heart drugs or not. The main goal is to see if this approach reduces the risk of heart problems caused by the chemotherapy drug daunorubicin.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2022

Expected to finish

Sep 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Signed informed consent obtained prior to conducting any study-specific screening procedures. 2. Willing and able to understand the nature of this study and to comply with both the study as well as follow-up procedures for the duration of the study. 3. Age ≥ 18 years old with newly-diagnosed Acute Myeloid Leukemia (AML) 4. ECOG performance status must be ≤ 2 5. Planning to receive initial induction therapy containing an anthracycline for AML. Participants may have started initial induction therapy if anthracycline has not yet been administered. 6. Adequate organ function as evidenced by the following laboratory findings: 1. Total bilirubin ≤ 1.5 x upper limit of normal (ULN) or \< 3 x ULN for patients with Gilbert's Syndrome 2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN 3. Creatinine clearance \> 60 mL/min 7. Ability to take oral medication and a willingness to adhere to the beta blocker and lisinopril regimen 8. Echocardiogram demonstrating an ejection fraction ≥ 50% prior to the initiation of induction chemotherapy 9. For females of reproductive potential and males: Agree to abstain from sexual activity or use reliable contraception while undergoing treatment with chemotherapy and/or ACE inhibitors due to the risk of teratogenicity to the fetus. Exclusion Criteria: 1. Ongoing use of any beta blocker, ACEi, or angiotensin II receptor agonist (ARB) at the time of pre-enrollment screening. 2. Uncontrolled, intercurrent illnesses including but not limited to symptomatic unstable angina pectoris, cardiac arrhythmias not well controlled with medications, myocardial infarction in the 6 months preceding registration or psychiatric illness/social situations that would limit compliance with study requirements as determined by the study personnel, all at the discretion of the treating oncologist. 3. Patient receiving concurrent investigational agents, or those who have received an investigational agent within one week of registration. Exception - Participants may receive concurrent investigational agents, or have done so within one week of registration if: * The side effects of the drug are well studied and well known AND * The drug is not known to be cardioprotective or cardiotoxic 4\. Females who are pregnant or lactating. 5\. Life-threatening illnesses other than AML, uncontrolled medical conditions or organ system dysfunction that, in the investigator's opinion, could compromise the patient's safety or study outcomes. 6\. Active, untreated and/or severe infections as determined by the treating oncologist. 7\. History of hematopoietic stem cell transplant (HSCT) with active graft vs host disease, immunosuppression other than low-dose prednisone (≤ 5mg) or calcineurin inhibitors within the four weeks preceding registration 8 Moderate or severe mitral or aortic valve disease, as determined by echocardiography 9\. Congestive heart failure as clinically diagnosed by treating oncologist at the time of presentation for induction chemotherapy, or documented diagnosed by a previous physician. 10\. History of (repaired or unrepaired) congenital heart disease that precludes recommendation for or administration of additional anthracyclines 11\. Significant liver disease, including cirrhosis or history of transplant or hepatorenal syndrome) 12\. Bradycardia (defined as baseline resting heart rate ≤ 60 beats per minute) or third degree atrioventricular heart block at presentation for induction chemotherapy. 13\. Baseline resting systolic blood pressure \< 95mmHg at presentation for induction chemotherapy. 14\. Documented allergy to beta blockers or ACE inhibitors.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • University of Virginia

    RECRUITING

    Charlottesville, Virginia, 22903, United States

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Other studies related to the condition(s) this trial covers.