AMLPhase 2AML 001NCT04977180
Cardioprotection in AML
A Phase 2 study testing Cardioprotection in people with AML and Acute Myeloid Leukemia, run by University of Virginia at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- AML, Acute Myeloid Leukemia
- What is being tested?
- Cardioprotection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Mar 2022to Sep 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
- Planning to receive initial induction therapy containing an anthracycline for AML. Participants may have started initial induction therapy if anthracycline has not yet been administered.
- Adequate organ function as evidenced by the following laboratory findings:
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- Total bilirubin ≤ 1.5 x upper limit of normal (ULN) or < 3 x ULN for patients with Gilbert's Syndrome
- Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
- Creatinine clearance > 60 mL/min
- Ability to take oral medication and a willingness to adhere to the beta blocker and lisinopril regimen
- Echocardiogram demonstrating an ejection fraction ≥ 50% prior to the initiation of induction chemotherapy
- For females of reproductive potential and males: 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.
Who cannot join
- 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.
- Exception - Participants may receive concurrent investigational agents, or have done so within one week of registration if:
- The side effects of the drug are well studied and well known AND
- The drug is not known to be cardioprotective or cardiotoxic
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- 4. Females who are pregnant or lactating.
- 5. Life-threatening illnesses other than AML, uncontrolled medical conditions or organ system dysfunction that, in the investigator's opinion, could compromise the patient's safety or study outcomes.
- 6. Active, untreated and/or severe infections as determined by the treating oncologist.
- 7. History of hematopoietic stem cell transplant (HSCT) with active graft vs host disease, immunosuppression other than low-dose prednisone (≤ 5mg) or calcineurin inhibitors within the four weeks preceding registration
- 8 Moderate or severe mitral or aortic valve disease, as determined by echocardiography
- 9. Congestive heart failure as clinically diagnosed by treating oncologist at the time of presentation for induction chemotherapy, or documented diagnosed by a previous physician.
- 10. History of (repaired or unrepaired) congenital heart disease that precludes recommendation for or administration of additional anthracyclines
- 11. Significant liver disease, including cirrhosis or history of transplant or hepatorenal syndrome)
- 12. Bradycardia (defined as baseline resting heart rate ≤ 60 beats per minute) or third degree atrioventricular heart block at presentation for induction chemotherapy.
- 13. Baseline resting systolic blood pressure < 95mmHg at presentation for induction chemotherapy.
- 14. Documented allergy to beta blockers or ACE inhibitors.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Avani Hopkins, RN contact
United States1 site, 1 recruiting
- Recruiting
University of Virginia
Charlottesville, Virginia, 22903
Cory Caldwell, 434-297-4182, CJC2P@uvahealth.org
Avani Hopkins, AJH7JQE@uvahealth.org
About this study
Official 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
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.
Read the detailed description
Participants will know which group they are assigned to, and if someone in the group not receiving the preventive drugs needs these drugs for their clinical care, they will be able to receive them.
Participants in both groups will receive the standard clinical care medicines and lab tests for their AML. Everyone will have electrocardiograms (also called ECGs or EKGs) and echocardiograms before and at multiple timepoints during the study. They will also have a special blood test to see their levels of troponin, a protein that helps with muscle contractions in your heart. All participants will complete questionnaires at a few timepoints during the study to measure their quality of life. Participants in the preventive beta blocker and ACEi group will take these drugs when they're in the hospital and at home, keeping a diary of when they take it when they're at home.
The hypothesis of the study is that taking a beta blocker and ACEi during initial therapy for AML and through about 90 days after they last take an anthracycline will prevent the development of this heart problem.
- Conditions
- AML, Acute Myeloid Leukemia
- Being tested
- Cardioprotection
- Keywords
- cardioprotection
- Medical subject headings
- Leukemia, Myeloid, Acute
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CardioprotectionDrug
Preventive beta blocker (metoprolol or carvedilol) and an ACE inhibitor (lisinopril)
| Study group | Role | What they receive |
|---|---|---|
| Treatment arm (beta blocker and ACE inhibitor) | Experimental | 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). If participants are unable to tolerate either beta blocker (e.g., heart rate is low at baseline or is lowered to an unsafe level with the beta blocker), no beta blocker may be administered as part of this study treatment. They will also undergo regular assessments via ECG/EKG and echocardiogram, and to measure troponin levels. Receives: Drug: Cardioprotection |
| Standard Clinical Care | No intervention | Participants will receive standard clinical care, but will also undergo regular assessments via ECG/EKG and echocardiogram, and to measure troponin levels |
What is being measured
The primary outcome is the main question the study is designed to answer.
Left ventricular ejection fraction (LVEF)
As determined by echocardiogram
Measured: Baseline through 90 days after first day of last cycle of anthracycline (usually up to 6 months later)
Secondary outcomes (4)
Congestive heart failure
As diagnosed by treating physician
Measured: Baseline through 90 days after first day of last cycle of anthracycline (usually up to 6 months later)
Changes in quality of life
As measured by the FACT-Leu questionnaire
Measured: Baseline through 90 days after first day of last cycle of anthracycline (usually up to 6 months later)
Global longitudinal strain
As measured by echocardiogram
Measured: Baseline through 90 days after first day of last cycle of anthracycline (usually up to 6 months later)
Troponin levels
Frequency of elevation in troponin and average troponin
Measured: Baseline through 90 days after first day of last cycle of anthracycline (usually up to 6 months later)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2021
- Study start4 Mar 2022
- Primary completionMar 2028 (estimated)
- Study completionSep 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AMLStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 70 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Virginia
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Michael Keng, MD, University of Virginia
- Investigators
- Michael Keng, MD, Principal investigator, UVA
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04977180
- Sponsor's protocol ID
- HSR210151
- Acronym
- AML 001
- Status last verified
- Apr 2026
- First submitted
- 19 Jul 2021
- Last updated
- 5 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04977180
- Acronym / sponsor ID
- AML 001 / HSR210151
- Conditions
- AML, Acute Myeloid Leukemia
- Keywords
- cardioprotection
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 70 participants (estimated)
- Lead sponsor
- University of VirginiaUniversity, hospital or other
- Study start
- 4 Mar 2022 (actual)
- Primary completion
- Mar 2028 (estimated)
- Study completion
- Sep 2028 (estimated)
- First posted
- 26 Jul 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Participants will know which group they are assigned to, and if someone in the group not receiving the preventive drugs needs these drugs for their clinical care, they will be able to receive them.
Participants in both groups will receive the standard clinical care medicines and lab tests for their AML. Everyone will have electrocardiograms (also called ECGs or EKGs) and echocardiograms before and at multiple timepoints during the study. They will also have a special blood test to see their levels of troponin, a protein that helps with muscle contractions in your heart. All participants will complete questionnaires at a few timepoints during the study to measure their quality of life. Participants in the preventive beta blocker and ACEi group will take these drugs when they're in the hospital and at home, keeping a diary of when they take it when they're at home.
The hypothesis of the study is that taking a beta blocker and ACEi during initial therapy for AML and through about 90 days after they last take an anthracycline will prevent the development of this heart problem.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment arm (beta blocker and ACE inhibitor) | Experimental | Drug: CardioprotectionParticipants 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). If participants are unable to tolerate either beta blocker (e.g., heart rate is low at baseline or is lowered to an unsafe level with the beta blocker), no beta blocker may be administered as part of this study treatment. They will also undergo regular assessments via ECG/EKG and echocardiogram, and to measure troponin levels. |
| Standard Clinical Care | No intervention | –Participants will receive standard clinical care, but will also undergo regular assessments via ECG/EKG and echocardiogram, and to measure troponin levels |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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
- Planning to receive initial induction therapy containing an anthracycline for AML. Participants may have started initial induction therapy if anthracycline has not yet been administered.
Key exclusion criteria (17 listed)
- 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.
- Exception - Participants may receive concurrent investigational agents, or have done so within one week of registration if:
- The side effects of the drug are well studied and well known AND
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CardioprotectionPreventive beta blocker (metoprolol or carvedilol) and an ACE inhibitor (lisinopril) | Drug | Treatment arm (beta blocker and ACE inhibitor) |
Primary outcome
Left ventricular ejection fraction (LVEF)
Time frame: Baseline through 90 days after first day of last cycle of anthracycline (usually up to 6 months later)
As determined by echocardiogram
4 secondary outcomes
Congestive heart failure
Time frame: Baseline through 90 days after first day of last cycle of anthracycline (usually up to 6 months later)
Changes in quality of life
Time frame: Baseline through 90 days after first day of last cycle of anthracycline (usually up to 6 months later)
Global longitudinal strain
Time frame: Baseline through 90 days after first day of last cycle of anthracycline (usually up to 6 months later)
Troponin levels
Time frame: Baseline through 90 days after first day of last cycle of anthracycline (usually up to 6 months later)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Avani Hopkins, RN contact
Michael Keng, MD principal investigator
UVA
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Cardioprotection in people with AML and Acute Myeloid Leukemia, run by University of Virginia at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 5 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Cory Caldwell, RN (434-297-4182, CJC2P@uvahealth.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Left ventricular ejection fraction (LVEF) (time frame: Baseline through 90 days after first day of last cycle of anthracycline (usually up to 6 months later)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 May 2026.