OncoMatch/Clinical Trials/NCT04977180
Cardioprotection in AML
Is NCT04977180 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies Cardioprotection for aml.
Treatment: Cardioprotection — 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.
Check if I qualifyExtracted eligibility criteria
Cancer type
Acute Myeloid Leukemia
Performance status
ECOG 0–2(Ambulatory, capable of self-care)
Prior therapy
Lab requirements
Kidney function
Creatinine clearance > 60 mL/min
Liver function
Total bilirubin ≤ 1.5 x ULN or < 3 x ULN for patients with Gilbert's Syndrome; AST and ALT ≤ 2.5 x ULN
Cardiac function
Ejection fraction ≥ 50% prior to initiation of induction chemotherapy; no moderate or severe mitral or aortic valve disease; no congestive heart failure; no history of congenital heart disease precluding anthracyclines; no bradycardia (resting HR ≤ 60 bpm); no third degree AV block; baseline resting systolic BP ≥ 95 mmHg
Echocardiogram demonstrating an ejection fraction ≥ 50% prior to the initiation of induction chemotherapy; Moderate or severe mitral or aortic valve disease, as determined by echocardiography [excluded]; Congestive heart failure as clinically diagnosed... [excluded]; History of (repaired or unrepaired) congenital heart disease that precludes recommendation for or administration of additional anthracyclines [excluded]; Bradycardia (defined as baseline resting heart rate ≤ 60 beats per minute) or third degree atrioventricular heart block at presentation for induction chemotherapy [excluded]; Baseline resting systolic blood pressure < 95mmHg at presentation for induction chemotherapy [excluded].
Structured fields extracted by AI. May contain errors — verify against the official protocol.
US trial sites
- University of Virginia · Charlottesville, Virginia
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