Carvedilol in Preventing Heart Failure in Childhood Cancer Survivors

Overview

  • Study type

    Interventional
  • Study phase

    II
  • Study IDs

  • Describes the nature of a clinical study. Types include:

    • Observational study — observes people and measures outcomes without affecting results.
    • Interventional study (clinical trial) — studies new tests, treatments, drugs, surgical procedures or devices.
    • Medical records research — uses historical information collected from medical records of large groups of people to study how diseases progress and which treatments and surgeries work best.
  • During the early phases (phases 1 and 2), researchers assess safety, side effects, optimal dosages and risks/benefits. In the later phase (phase 3), researchers study whether the treatment works better than the current standard therapy. They also compare the safety of the new treatment with that of current treatments. Phase 3 trials include large numbers of people to make sure that the result is valid. There are also less common very early (phase 0) and later (phase 4) phases. Phase 0 trials are small trials that help researchers decide if a new agent should be tested in a phase 1 trial. Phase 4 trials look at long-term safety and effectiveness, after a new treatment has been approved and is on the market.

  • Site IRB
    • Rochester, Minnesota: 16-005704
    NCT ID: NCT02717507
    Sponsor Protocol Number: ALTE1621

About this study

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.

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. If you need assistance understanding the eligibility criteria, please contact the study team.

See eligibility criteria

Inclusion Criteria:

  • Males must weigh >55 Kg
  • Females must weigh >50 Kg
  • Patient must have had a cancer diagnosis < 21 years of age, irrespective of current age
  • Patient must have a lifetime cumulative anthracycline dose: >= 300 mg/m^2 DOXOrubicin equivalent without the protection of dexrazoxane (zinecard) therapy
  • 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
  • Shortening fraction of < 25% by echocardiogram
  • 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 atrioventricular 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
  • Significant hepatic (serum aspartate aminotransferase [AST] and/or alanine aminotransferase [ALT] > 3 time 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
  • Insulin dependent diabetes mellitus
  • Anemia (hematocrit < 28%)
  • Use of select cytochrome P450, family 2, subfamily D, polypeptide 6 (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 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

Participating Mayo Clinic locations

Study statuses change often. Please contact us for help.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Carola A Arndt, M.D.

Open for enrollment

Contact information:

Cancer Center Clinical Trials Referral Office

855-776-0015

Additional contact information

Cancer-related trials contact form

Phone: 855-776-0015 (toll-free)

International patient clinical studies questions