NCT04977180 · University of Virginia
Cardioprotection in AML
(AML 001)
What this study is about
Patients with acute myeloid leukemia (AML) often receive a drug called daunorubicin. Daunorubicin is a type of drug called an anthracycline, which increases the risk of some damage to the heart. Beta blockers and angiotensin-converting enzyme inhibitors (ACEi) are two types of drugs that are often used (and are FDA approved) to treat the type of damage to the heart caused by anthracyclines.
View original scientific description
Patients with acute myeloid leukemia (AML) often receive a drug called daunorubicin. Daunorubicin is a type of drug called an anthracycline, which increases the risk of some damage to the heart. Beta blockers and angiotensin-converting enzyme inhibitors (ACEi) are two types of drugs that are often used (and are FDA approved) to treat the type of damage to the heart caused by anthracyclines. They have also been used in some populations to prevent this type of heart damage. In this study, participants will be randomly assigned to either preventively take a beta blocker and ACEi or not to receive these. The primary purpose of the study is to look at how often people in each group develop this type of heart damage. The study investigators will also collect data about your quality of life and other changes in your heart function. Frequency and severity of anthracycline-induced cardiotoxicity among patients receiving acute myeloid leukemia (AML) chemotherapy is unknown. We hypothesize that up-titrating study agents to maximum tolerated dosage at the time of induction (starting treatment for AML) will prevent the development of systolic dysfunction as determined on serial echocardiography.
Interventions
DRUG
Cardioprotection
Preventive beta blocker (metoprolol or carvedilol) and an ACE inhibitor (lisinopril)
Primary outcome measures
Left ventricular ejection fraction (LVEF)
Time frame: Baseline through 90 days after first day of last cycle of anthracycline (usually up to 6 months later)
As determined by echocardiogram
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- Signed informed consent obtained prior to conducting any study-specific screening procedures.
- 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.
- Age ≥ 18 years old with newly-diagnosed Acute Myeloid Leukemia (AML)
- ECOG performance status must be ≤ 2
- 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.
- Adequate organ function as evidenced by the following laboratory findings:
- Total bilirubin ≤ 1.5 x upper limit of normal (ULN) or \< 3 x ULN for patients with Gilbert's Syndrome
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
- Creatinine clearance \> 60 mL/min
- Ability to take oral medication and a willingness to adhere to the beta blocker and lisinopril regimen
- Echocardiogram demonstrating an ejection fraction ≥ 50% prior to the initiation of induction chemotherapy
- 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
- Ongoing use of any beta blocker, ACEi, or angiotensin II receptor agonist (ARB) at the time of pre-enrollment screening.
- 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.
- 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.
Where
- Charlottesville, Virginia
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced May 5, 2026 · Source of record for eligibility and locations