Cardioprotection in AML

Eligibility Criteria

• 1. Signed informed consent obtained prior to conducting any study-specific screening procedures.
• 2. 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.
• 3. Age ≥ 18 years old with newly-diagnosed Acute Myeloid Leukemia (AML)
• 4. ECOG performance status must be ≤ 2
• 5. 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.
• 6. Adequate organ function as evidenced by the following laboratory findings:
• 1. Total bilirubin ≤ 1.5 x upper limit of normal (ULN) or \< 3 x ULN for patients with Gilbert's Syndrome
• 2. Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤ 2.5 x ULN
• 3. Creatinine clearance \> 60 mL/min
• 7. Ability to take oral medication and a willingness to adhere to the beta blocker and lisinopril regimen
• 8. Echocardiogram demonstrating an ejection fraction ≥ 50% prior to the initiation of induction chemotherapy
• 9. 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.
• 1. Ongoing use of any beta blocker, ACEi, or angiotensin II receptor agonist (ARB) at the time of pre-enrollment screening.
• 2. 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.
• 3. 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
• * The drug is not known to be cardioprotective or cardiotoxic
• 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
• 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.