Actively Recruiting
Cardioprotection in AML
Led by University of Virginia · Updated on 2026-05-05
70
Participants Needed
1
Research Sites
339 weeks
Total Duration
On this page
AI-Summary
What this Trial 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. 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.
CONDITIONS
Official Title
Cardioprotection in AML
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Signed informed consent before any study procedures
- Able and willing to understand and follow study and follow-up requirements
- Age 18 years or older with newly diagnosed acute myeloid leukemia (AML)
- ECOG performance status of 2 or less
- Planning to receive initial induction therapy containing an anthracycline for AML; may have started induction but not yet received anthracycline
- Adequate organ function: total bilirubin ≤1.5 x upper limit of normal (ULN) or <3 x ULN if Gilbert's Syndrome; AST and ALT ≤2.5 x ULN; creatinine clearance >60 mL/min
- Able to take oral medication and willing to follow beta blocker and lisinopril regimen
- Echocardiogram showing ejection fraction ≥50% before starting induction chemotherapy
- For females of reproductive potential and males: agree to abstain from sexual activity or use reliable contraception during treatment due to risk to fetus
You will not qualify if you...
- Current use of any beta blocker, ACE inhibitor, or angiotensin II receptor blocker at screening
- Uncontrolled illnesses like unstable angina, poorly controlled arrhythmias, recent heart attack within 6 months, or psychiatric/social issues limiting study compliance
- Receiving or recently received investigational drugs within one week unless well-studied and not cardioprotective or cardiotoxic
- Pregnant or breastfeeding females
- Life-threatening illnesses other than AML or uncontrolled medical conditions affecting safety or outcomes
- Active, untreated, or severe infections
- History of stem cell transplant with active graft-versus-host disease or recent immunosuppression beyond low-dose prednisone or calcineurin inhibitors
- Moderate or severe mitral or aortic valve disease
- Clinical heart failure at chemotherapy start or previous diagnosis
- History of congenital heart disease preventing anthracycline use
- Significant liver disease including cirrhosis, transplant history, or hepatorenal syndrome
- Bradycardia (resting heart rate ≤60 bpm) or third degree heart block at chemotherapy start
- Resting systolic blood pressure below 95 mmHg at chemotherapy start
- Known allergy to beta blockers or ACE inhibitors
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
University of Virginia
Charlottesville, Virginia, United States, 22903
Actively Recruiting
Research Team
C
Cory Caldwell, RN
CONTACT
A
Avani Hopkins, RN
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
PREVENTION
Number of Arms
2
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here