Clinical Trial

Cardioprotection in AML

Study acronym: AML 001
Recruiting Phase 2
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Summary
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.
Protocol Amendment History 7 amendments
This ClinicalTrials.gov record has been amended 7 times since 2021-07-19; most recent amendment 2026-04-28.
Status change: Not Yet Recruiting → Recruiting 2022-03-09
Trial Details
NCT Number NCT04977180
Lead Sponsor University of Virginia
Conditions AML, Acute Myeloid Leukemia
Enrollment 70 participants
Start Date 2022-03-04
Primary Completion 2028-03 (estimated)
Study Completion 2028-09 (estimated)
Updated on ClinicalTrials.gov 2026-05-05