Carvedilol in Preventing Heart Failure in Childhood Cancer Survivors

Korábbi kezelés

• Receiving treatment for cardiomyopathy or heart failure
• Sustained or symptomatic ventricular dysrhythmias uncontrolled with drug therapy or implantable device
• Use of an investigational drug or beta adrenergic blockers, including metoprolol, sotalol, within 30 days of enrollment
• Currently using select CYP2D6 inhibitor or inducer medications
• Female patients who are pregnant are not eligible; women of childbearing potential require a negative pregnancy test prior to starting study drug
• 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

Más betegség

• Uncorrected primary obstructive or severe regurgitative valvular disease:
  • Nondilated (restrictive); or
  • Hypertrophic cardiomyopathy; or
  • Significant systemic ventricular outflow obstruction
• Significant conduction defects (i.e. second or third degree atrio-ventricular block or sick sinus syndrome)
• Bradycardia: heart rate < 50 beats per minute (BPM)
• History of drug sensitivity or allergic reaction to alpha or beta-blockers
• History or current clinical evidence of moderate-to-severe obstructive pulmonary disease or reactive airway diseases (i.e. asthma) requiring therapy
• 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
• All institutional, Food and Drug Administration (FDA), and National Cancer Institute (NCI) requirements for human studies must be met

Laborértékek

• 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
• Use of any other blood pressure lowering medication for treatment of hypertension within 30 days of enrollment except calcium channel blockers and diuretics
• Serum aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3 times upper limit of institutional normal
• Uncontrolled diabetes (controlled diabetes per the American Diabetes Association and International Diabetes Center's Glycemic Target Goals is hemoglobin A1C < 7%)

Egyéb

• Low resting systolic blood pressure: < 90 mmHg
• Anemia (hematocrit < 28%)
• Inability to swallow pills
• Lactating females are not eligible unless they have agreed to not breastfeed their infants
• All patients and/or their parents or legal guardians must sign a written informed consent

• 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