Study For Patients With Newly Diagnosed Acute Myeloid Leukemia To See If Drugs for Treating Heart Problems May Help To Prevent Heart Problems

UVA Tracking #
HSR210151
Principal Investigator
Michael K Keng
Contact
Kelly Reed
Contact Email
Contact Phone
434.327.2138
Official Trial Title
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
Study Description

The University of Virginia Cancer Center is conducting a clinical research study for patients with newly diagnosed acute myeloid leukemia (AML). One of the drugs used in the standard treatment for AML can increase risk of damage to the heart. Beta blockers and angiotensin-converting enzyme inhibitors (ACE inhibitors) are used to treat people who have this kind of damage to the heart. These drugs are taken orally (pills taken by mouth). The purpose of this study is to see how often newly diagnosed AML patients that receive these drugs during initial treatment develop this type of damage and how often this damage develops in people who don’t receive these drugs preventively. Participants will be randomly assigned to receive the drugs preventively with their standard clinical treatment or to receive standard clinical treatment without these drugs (unless they are needed for treating heart damage). Participants will not get to choose which group they are assigned to, but they will know what they are receiving.

The beta blockers and ACE inhibitors used in this study are approved by the FDA for treating heart damage but not approved to prevent heart damage in this population. Participants will receive study treatment for as long as they are receiving standard clinical care that includes a drug that increases risk of this heart damage and for about 3 months afterward. Before, during and after study treatment, participants will be asked to complete questionnaires about their quality of life. Before and during study treatment, participants will have frequent electrocardiograms (ECGs/EKGs) and blood tests to look at their heart function. Participants will be followed after they have completed the study treatment for about 6 months. Study-specific tests that are being done beyond standard of care will be provided at no cost to the patient/participant or his/her/their insurance.

Additional information can be found here: https://clinicaltrials.gov/ct2/show/NCT04977180

Compensation

This study does not offer compensation or reimbursement.