Cardioprotection in AML
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity of Virginia
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
Signed informed consent obtained prior to conducting any study-specific screening procedures.
Willing and able to understand the nature of this study and to comply with both the study as well as follow-up procedures for the duration of the study.
Age ≥ 18 years old with newly-diagnosed Acute Myeloid Leukemia (AML)
ECOG performance status must be ≤ 2
Disqualifiers
Ongoing use of any beta blocker, ACEi, or angiotensin II receptor agonist (ARB) at the time of pre-enrollment screening.
Uncontrolled, intercurrent illnesses including but not limited to symptomatic unstable angina pectoris, cardiac arrhythmias not well controlled with medications, myocardial infarction in the 6 months preceding registration or psychiatric illness/social situations that would limit compliance with study requirements as determined by the study personnel, all at the discretion of the treating oncologist.
Patient receiving concurrent investigational agents, or those who have received an investigational agent within one week of registration.
The side effects of the drug are well studied and well known AND
Trial design
Design model
Parallel
Treatments tested in this trial
Cardioprotection
DrugPreventive beta blocker (metoprolol or carvedilol) and an ACE inhibitor (lisinopril)
Treatment groups
70 Participants
are divided into 2 treatment groupsGroup A: Treatment arm (beta blocker and ACE inhibitor)Experimental treatment 1 intervention
Group B: Standard Clinical CareNo intervention 0 interventions
Trial outcomes
Primary outcomes
1
Left ventricular ejection fraction (LVEF)
As determined by echocardiogram
Time frame
Baseline through 90 days after first day of last cycle of anthracycline (usually up to 6 months later)Secondary outcomes
1
Congestive heart failure
As diagnosed by treating physician
Time frame
Baseline through 90 days after first day of last cycle of anthracycline (usually up to 6 months later)2
Changes in quality of life
As measured by the FACT-Leu questionnaire
Time frame
Baseline through 90 days after first day of last cycle of anthracycline (usually up to 6 months later)3
Global longitudinal strain
As measured by echocardiogram
Time frame
Baseline through 90 days after first day of last cycle of anthracycline (usually up to 6 months later)4
Troponin levels
Frequency of elevation in troponin and average troponin
Time frame
Baseline through 90 days after first day of last cycle of anthracycline (usually up to 6 months later)Sponsors and contacts
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Source ClinicalTrials.gov