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Cardioprotection in AML

Study acronym: AML 001
StatusRecruiting
PhasePhase 2
Started
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Record History

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  1. 2 versions Re-verified since Feb 19, 2025, no change to tracked fieldsv7-v8
  2. Enrollment target: 28 to 70
    • Primary completion date: Jan 1, 2025 to Mar 2028
    • Study completion date: Sep 1, 2025 to Sep 2028
    • Site contact updated
    v6
  3. Eligibility criteria expanded, about 9 words
    • Site contact updated
    v5
  4. Eligibility criteria shortened, about 111 wordsv4
  5. Eligibility criteria expanded, about 3 wordsv3
  6. Trial status: Not Yet Recruiting to Recruitingv2 Show 4 more changesShow less
    • Start date changed from estimate of Sep 1, 2021 to Mar 4, 2022
    • Primary completion date: Sep 1, 2024 to Jan 1, 2025
    • Study completion date: May 1, 2025 to Sep 1, 2025
    • Site details revised
  7. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT04977180
Lead Sponsor University of Virginia
Conditions
(from sponsor)		 AML, Acute Myeloid Leukemia
Related terms Leukemia, Myeloid, Acute
Enrollment 70 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov