RecruitingPhase 2NCT04977180

Cardioprotection in AML

Phase II Trial of Cardioprotective Prophylaxis With Combination of Beta Blocker and Angiotensin-Converting Enzyme Inhibitors During Intensive Chemotherapy for Patients With Newly Diagnosed Acute Myeloid Leukemia


Sponsor

University of Virginia

Enrollment

70 participants

Start Date

Mar 4, 2022

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether adding two heart-protective medicines — a beta blocker and a blood pressure drug (ACE inhibitor) — can prevent heart damage in patients receiving chemotherapy for newly diagnosed acute myeloid leukemia (AML). Chemotherapy for AML often uses drugs that can weaken the heart. **You may be eligible if...** - You are 18 or older with a new diagnosis of AML - You are planned to receive chemotherapy containing an anthracycline (a common AML treatment that can damage the heart) - Your heart is functioning normally before chemotherapy (ejection fraction ≥50%) - Your liver and kidney function are within acceptable ranges **You may NOT be eligible if...** - You are already taking a beta blocker, ACE inhibitor, or ARB - You have poorly controlled high blood pressure or recent serious heart events - You are pregnant or not using contraception Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGCardioprotection

Preventive beta blocker (metoprolol or carvedilol) and an ACE inhibitor (lisinopril)


Locations(1)

University of Virginia

Charlottesville, Virginia, United States

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NCT04977180


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