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Clinical Trials Search at Vanderbilt-Ingram Cancer Center

Carvedilol in Preventing Heart Failure in Childhood Cancer Survivors

This randomized phase IIb trial studies how well low-dose carvedilol works in preventing heart failure in cancer survivors exposed to high dose anthracyclines for management of childhood cancer. Patients who received high-dose anthracycline chemotherapy are at a much greater risk for developing heart failure compared to survivors who didn’t get any anthracycline chemotherapy. Heart failure happens when the heart muscle has been weakened and can’t pump blood as well as it should. Carvedilol may help lower the risk of cardiovascular complications.
Miscellaneous, Pediatrics
Phase II
Both
Therapy (NOS)
Blinded Drug
Friedman, Debra
National
Vanderbilt University
10-03-2016
Prevention
COGALTE1621
NCT02717507

Eligibility

0 Years
BOTH
NO
Inclusion Criteria:

Males and females must weigh >= 40 Kg

Patient must have had a cancer diagnosis
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
Patient must have completed cancer treatment >= 2 years prior to study enrollment



Exclusion Criteria:

Receiving treatment for cardiomyopathy or heart failure

Ejection fraction of
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
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:
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
Anemia (hematocrit
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

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