Carvedilol in Preventing Heart Failure in Childhood Cancer Survivors

Inclusion Criteria:

Males and females must weigh >= 40 Kg
Patient must have had a cancer diagnosis < 22 years of age, irrespective of current age

Patient must have a lifetime cumulative anthracycline dose of >= 250 mg/m^2 DOXOrubicin equivalent without the protection of dexrazoxane (Zinecard) therapy; the anthracycline dose threshold must be met as part of the treatment of a cancer that was diagnosed at < 22 years of age

Note: Institutional records (e.g., clinic note, treatment summary, chemotherapy roadmap) can be used to document lifetime receipt of anthracycline dose
Patient must have completed cancer treatment >= 2 years prior to study enrollment

Exclusion Criteria:

Receiving treatment for cardiomyopathy or heart failure

Ejection fraction of < 50% (by radionuclide angiogram or echocardiogram) or shortening fraction of < 25% (by echocardiogram)

Note: for instances where both are reported, and one is below the threshold, the site will have the option to re-measure it centrally at the core lab

Uncorrected primary obstructive or severe regurgitative valvular disease:

Nondilated (restrictive); or
Hypertrophic cardiomyopathy; or
Significant systemic ventricular outflow obstruction
Sustained or symptomatic ventricular dysrhythmias uncontrolled with drug therapy or implantable device
Significant conduction defects (i.e. second or third degree atrio-ventricular block or sick sinus syndrome)
Bradycardia: heart rate < 50 beats per minute (BPM)
Use of an investigational drug or beta adrenergic blockers, including metoprolol, sotalol, within 30 days of enrollment
History of drug sensitivity or allergic reaction to alpha or beta-blockers
Low resting systolic blood pressure: < 90 mmHg
Use of any other blood pressure lowering medication for treatment of hypertension within 30 days of enrollment except calcium channel blockers and diuretics
History or current clinical evidence of moderate-to-severe obstructive pulmonary disease or reactive airway diseases (i.e. asthma) requiring therapy
Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3 times upper limit of institutional normal
Gastrointestinal, or biliary disorders that could impair absorption, metabolism, or excretion of orally administered medications
Endocrine disorders (such as primary aldosteronism, pheochromocytoma, hyper- or hypothyroidism) not controlled with medication
Uncontrolled diabetes (controlled diabetes per the American Diabetes Association and International Diabetes Center's Glycemic Target Goals is hemoglobin A1C < 7%)
Anemia (hematocrit < 28%)
Currently using select CYP2D6 inhibitor or inducer medications
Inability to swallow pills
Female patients who are pregnant are not eligible; women of childbearing potential require a negative pregnancy test prior to starting study drug
Lactating females are not eligible unless they have agreed to not breastfeed their infants
Sexually active female patients of reproductive potential are not eligible unless they agree to use an effective contraceptive method during study and for 2 months after stopping the study drug; abstinence is an acceptable method of birth control
All patients and/or their parents or legal guardians must sign a written informed consent
All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met