Heart shield for chemo: new trial aims to protect AML patients
NCT ID NCT04977180
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.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Mar 2022
- Expected to finish
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Sep 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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University of Virginia
RECRUITINGCharlottesville, Virginia, 22903, United States
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Other studies related to the condition(s) this trial covers.
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- Breath test aims to classify leukaemia in hours, not days
- Can an HDAC inhibitor wipe out residual leukemia cells?
- Can an experimental pill block a cancer-driving enzyme in hard-to-treat leukemia?
- Two-Drug combo targets leukemia that outsmarted its first treatment
- Tweaking donor cells may shield older transplant patients from a dangerous complication