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ACE Inhibitor and Beta Blocker
Cardioprotective Drugs for Acute Myeloid Leukemia (AML 001 Trial)
Phase 2
Recruiting
Led By Michael Keng
Research Sponsored by University of Virginia
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Agree to abstain from sexual activity or use reliable contraception while undergoing treatment with chemotherapy and/or ACE inhibitors due to the risk of teratogenicity to the fetus for females of reproductive potential and males
ECOG performance status must be ≤ 2
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline through 90 days after first day of last cycle of anthracycline (usually up to 6 months later)
Awards & highlights
AML 001 Trial Summary
This trial is looking at whether giving patients beta blockers and ACE inhibitors during treatment for AML will prevent heart damage.
Who is the study for?
Adults over 18 with newly-diagnosed Acute Myeloid Leukemia (AML) who are about to start or have just started induction therapy without anthracycline can join. They must be able to take oral meds, have good organ function, and an ejection fraction ≥ 50%. Women of childbearing age and men must use contraception. Can't join if already using heart meds like beta blockers or ACEi, have severe illnesses/heart issues, pregnant/lactating women, or those with certain medical conditions.Check my eligibility
What is being tested?
The trial is testing whether taking a beta blocker and ACE inhibitor before starting chemotherapy can prevent heart damage caused by the drug daunorubicin in AML patients. Participants will either receive these drugs as prevention or not. The study measures how often heart damage occurs and monitors overall heart health and quality of life.See study design
What are the potential side effects?
Potential side effects from beta blockers may include fatigue, cold hands/feet, weight gain; while ACE inhibitors might cause coughing, increased blood potassium levels, low blood pressure, dizziness. Side effects vary among individuals.
AML 001 Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I agree to use birth control or abstain from sex during my treatment.
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I can take care of myself and am up and about more than half of my waking hours.
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I am 18 or older and have been recently diagnosed with AML.
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My organ functions are within normal ranges according to recent tests.
AML 001 Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline through 90 days after first day of last cycle of anthracycline (usually up to 6 months later)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through 90 days after first day of last cycle of anthracycline (usually up to 6 months later)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Left ventricular ejection fraction (LVEF)
Secondary outcome measures
Changes in quality of life
Congestive heart failure
Global longitudinal strain
+1 moreAML 001 Trial Design
2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment arm (beta blocker and ACE inhibitor)Experimental Treatment1 Intervention
Participants will receive a beta blocker (either metoprolol or carvedilol) and an ACE inhibitor (lisinopril) at standard doses based on tolerance starting from when they start induction therapy for AML through 90 days after the first day of the last cycle of therapy that includes an anthracycline (whether that is in the induction, re-induction, or consolidation phase of treatment). They will also undergo regular assessments via ECG/EKG and echocardiogram, and to measure troponin levels
Group II: Standard Clinical CareActive Control1 Intervention
Participants will receive standard clinical care, but will also undergo regular assessments via ECG/EKG and echocardiogram, and to measure troponin levels
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Who is running the clinical trial?
University of VirginiaLead Sponsor
757 Previous Clinical Trials
1,245,220 Total Patients Enrolled
Michael KengPrincipal InvestigatorUVA
Michael Keng, MDPrincipal InvestigatorUVA
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been diagnosed with congestive heart failure by my oncologist.I do not have any severe or untreated infections.I have moderate or severe heart valve disease.I agree to use birth control or abstain from sex during my treatment.I can take care of myself and am up and about more than half of my waking hours.I am 18 or older and have been recently diagnosed with AML.I don't have any severe illnesses or uncontrolled conditions that could risk my safety or affect the study.I had a stem cell transplant and am on low-dose prednisone or calcineurin inhibitors.I do not have any uncontrolled illnesses.I am currently taking medication for blood pressure or heart conditions.I am not pregnant or breastfeeding.I am starting or have started treatment for AML that includes an anthracycline.I have a very slow heartbeat or a specific heart block.I have a serious liver condition, such as cirrhosis, or have had a liver transplant.I have a heart condition that prevents me from receiving certain chemotherapy drugs.My organ functions are within normal ranges according to recent tests.I can take pills and will follow the beta blocker and lisinopril plan.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment arm (beta blocker and ACE inhibitor)
- Group 2: Standard Clinical Care
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are there any eligibility criteria to participate in this research endeavor?
"As per the clinicaltrials.gov portal, this trial is currently recruiting participants for enrollment. The experiment was first listed on April 3rd 2022 and its information has been revised most recently on October 10th 2022."
Answered by AI
Is Cardioprotection a viable risk-mitigation strategy for patients?
"The safety rating of Cardioprotection is 2, as it has only undergone Phase 2 clinical trials, thus suggesting some level of risk despite the available data on its security."
Answered by AI
How extensive is the enrollment in this research trial?
"Affirmative. According to information hosted on clinicaltrials.gov, this research program is presently seeking out participants; the posting was initially made available on March 4th 2022 and edited for the last time October 10th 2022. A total of 28 individuals will be recruited from a single medical centre."
Answered by AI
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