Carvedilol in Preventing Heart Failure in Childhood Cancer Survivors

Completed · Phase 2 · Has a placebo group

Conditions studied: Hematopoietic and Lymphoid Cell Neoplasm, Malignant Solid Neoplasm

In brief

This 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.

Key facts

Study ID: NCT02717507
Run by: Children's Oncology Group
People needed: 196
Starts: 2016-04-04
Expected to finish: 2025-03-31
Last updated by the study team: 2025-04-23

Who can join

Age: any. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Phoenix Childrens Hospital — Phoenix, Arizona, United States
Arkansas Children's Hospital — Little Rock, Arkansas, United States
Kaiser Permanente Downey Medical Center — Downey, California, United States
City of Hope Comprehensive Cancer Center — Duarte, California, United States
Miller Children's and Women's Hospital Long Beach — Long Beach, California, United States
Children's Hospital Los Angeles — Los Angeles, California, United States
Kaiser Permanente-Oakland — Oakland, California, United States
Children's Hospital of Orange County — Orange, California, United States
University of California Davis Comprehensive Cancer Center — Sacramento, California, United States
Rady Children's Hospital - San Diego — San Diego, California, United States
Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center — Torrance, California, United States
Children's Hospital Colorado — Aurora, Colorado, United States
Rocky Mountain Hospital for Children-Presbyterian Saint Luke's Medical Center — Denver, Colorado, United States
Yale University — New Haven, Connecticut, United States
Alfred I duPont Hospital for Children — Wilmington, Delaware, United States
MedStar Georgetown University Hospital — Washington D.C., District of Columbia, United States
Children's National Medical Center — Washington D.C., District of Columbia, United States
Golisano Children's Hospital of Southwest Florida — Fort Myers, Florida, United States
University of Florida Health Science Center - Gainesville — Gainesville, Florida, United States
Nemours Children's Clinic-Jacksonville — Jacksonville, Florida, United States
AdventHealth Orlando — Orlando, Florida, United States
Nemours Children's Hospital — Orlando, Florida, United States
Nemours Children's Clinic - Pensacola — Pensacola, Florida, United States
Johns Hopkins All Children's Hospital — St. Petersburg, Florida, United States
Children's Hospital of Alabama — Birmingham, Alabama, United States

Full record on ClinicalTrials.gov

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