70 Participants Needed

Cardioprotective Drugs for Acute Myeloid Leukemia

(AML 001 Trial)

KR
CC
TD
CC
AH
Overseen ByAvani Hopkins, RN
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 2 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests if taking beta blockers and ACE inhibitors can prevent heart damage in AML patients receiving daunorubicin chemotherapy. These medications help protect the heart by reducing stress and preventing damage. The study will compare heart health and quality of life between those who take these medications and those who do not.

Will I have to stop taking my current medications?

If you are currently using any beta blockers, ACE inhibitors, or angiotensin II receptor blockers, you will need to stop taking them before joining this trial. The trial does not specify about other medications, so it's best to discuss your current medications with the study team.

Is it safe to use cardioprotective drugs like ACE inhibitors and beta-blockers in humans?

Research shows that ACE inhibitors and beta-blockers are generally safe for humans and can help prevent heart problems caused by certain cancer treatments. They are used to protect heart function and have been studied for their safety in various conditions.12345

How is the cardioprotective drug treatment for acute myeloid leukemia different from other treatments?

This treatment is unique because it uses beta blockers and ACE inhibitors, which are typically used to protect the heart from damage, to prevent heart problems caused by chemotherapy in acute myeloid leukemia patients. Unlike traditional cancer treatments that focus solely on attacking cancer cells, this approach aims to protect the heart from the harmful side effects of chemotherapy.14567

What data supports the effectiveness of cardioprotective drugs for preventing heart damage in patients with acute myeloid leukemia?

Research shows that cardioprotective drugs like beta-blockers and ACE inhibitors can help prevent heart damage caused by certain cancer treatments. These drugs have been found to reduce heart problems in patients receiving chemotherapy, which suggests they might also help protect the heart in acute myeloid leukemia patients.34678

Who Is on the Research Team?

MK

Michael Keng, MD

Principal Investigator

UVA

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

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.
See 6 more

Exclusion 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.
See 11 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Induction Treatment

Participants receive induction therapy for AML, including daunorubicin and potentially beta blocker and ACE inhibitor for cardioprotection

6 weeks
Multiple visits for chemotherapy administration and monitoring

Consolidation Treatment

Continuation of AML treatment and cardioprotective measures, with regular assessments via ECG/EKG and echocardiogram

Up to 6 months
Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of heart function and quality of life

90 days after last anthracycline cycle
Regular follow-up visits

What Are the Treatments Tested in This Trial?

Interventions

  • Cardioprotection
Trial Overview 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.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Active Control
Group I: Treatment arm (beta blocker and ACE inhibitor)Experimental Treatment1 Intervention
Group II: Standard Clinical CareActive Control1 Intervention

Cardioprotection is already approved in United States, European Union for the following indications:

🇺🇸
Approved in United States as Beta blockers and ACE inhibitors for:
🇪🇺
Approved in European Union as Beta blockers and ACE inhibitors for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

University of Virginia

Lead Sponsor

Trials
802
Recruited
1,342,000+

Published Research Related to This Trial

The OVERCOME study is a randomized controlled trial involving 90 patients with acute leukemia or undergoing autologous stem cell transplantation, aimed at assessing the effectiveness of enalapril and carvedilol in preventing left ventricular dysfunction (LVD) caused by chemotherapy.
This study is significant as it is the first to evaluate the combined preventive effects of these medications on LVD in patients receiving intensive chemotherapy, with primary outcomes focused on changes in left ventricular ejection fraction and secondary outcomes including heart failure incidence.
Prevention of chemotherapy-induced left ventricular dysfunction with enalapril and carvedilol: rationale and design of the OVERCOME trial.Bosch, X., Esteve, J., Sitges, M., et al.[2018]
A survey of Canadian hematologists revealed that interruptions in cardiovascular (CV) medications, such as statins and antiplatelets, are common among acute leukemia patients undergoing intensive chemotherapy, which can negatively affect their heart health.
The findings emphasize the importance of collaboration between hematology and cardiology teams, as well as the involvement of multidisciplinary healthcare professionals, to enhance cardiovascular care during leukemia treatment.
Management of cardiovascular health in acute leukemia: a national survey.Durand, M., Lacaria, K., Sidsworth, M., et al.[2020]
A 52-year-old man with acute myeloid leukemia (AML) developed after coronary stenting was successfully treated with a combination of idarubicin and cytarabine, leading to over 6 years of disease-free survival.
The case highlights the importance of using antiplatelet drugs during chemotherapy for patients with coronary heart disease, emphasizing the need for personalized treatment strategies to manage potential adverse effects in complex cases.
New perspectives on treatment strategies for patient with acute myeloid leukemia and complex karyotype abnormalities after percutaneous coronary intervention: A case report.Wang, J., Chen, R., Lin, X., et al.[2022]

Citations

Prevention of chemotherapy-induced left ventricular dysfunction with enalapril and carvedilol: rationale and design of the OVERCOME trial. [2018]
Management of cardiovascular health in acute leukemia: a national survey. [2020]
New perspectives on treatment strategies for patient with acute myeloid leukemia and complex karyotype abnormalities after percutaneous coronary intervention: A case report. [2022]
Effect of Dexrazoxane on Left Ventricular Systolic Function and Treatment Outcomes in Patients With Acute Myeloid Leukemia: A Report From the Children's Oncology Group. [2021]
Prevention of anthracycline-induced cardiotoxicity: a systematic review and meta-analysis. [2021]
Protective Effects of ACEI/ARB on Left Ventricular Function in Anthracycline-Induced Chronic Cardiotoxicity: A Meta-Analysis of Randomized Controlled Trials. [2021]
7.Czech Republicpubmed.ncbi.nlm.nih.gov
[AT1 blockers - comparability with ACE inhibitors]. [2018]
Heart failure from cancer therapy: can we prevent it? [2021]
Unbiased ResultsWe believe in providing patients with all the options.
Your Data Stays Your DataWe only share your information with the clinical trials you're trying to access.
Verified Trials OnlyAll of our trials are run by licensed doctors, researchers, and healthcare companies.
Back to top
Terms of Service·Privacy Policy·Cookies·Security