196 Participants Needed

Carvedilol for Preventing Heart Failure in Childhood Cancer Survivors

Recruiting at 94 trial locations
Prior Safety DataThis treatment has passed at least one previous human trial
Approved in 4 JurisdictionsThis treatment is already approved in other countries

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Who Is on the Research Team?

SH

Saro H Armenian

Principal Investigator

Children's Oncology Group

Are You a Good Fit for This Trial?

This trial is for childhood cancer survivors who are now at risk of heart failure due to high-dose anthracycline chemotherapy. Participants must weigh at least 40 Kg, have been diagnosed with cancer before age 22, finished treatment at least 2 years ago, and received a certain amount of anthracycline without dexrazoxane protection.

Inclusion Criteria

I received a high dose of a specific chemotherapy drug for cancer treated before I was 22.
I was diagnosed with cancer before turning 22.
I weigh at least 40 kg.
See 1 more

Exclusion Criteria

Your blood doesn't have enough red cells.
I don't have stomach or liver problems affecting medication absorption.
My hormone-related condition is not controlled by medication.
See 20 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive low-dose carvedilol or placebo orally once or twice daily for 24 months

24 months
Regular visits at baseline, 6 months, 12 months, 18 months, and 24 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

3 years

What Are the Treatments Tested in This Trial?

Interventions

  • Carvedilol
Trial Overview The study tests if low-dose Carvedilol can prevent heart failure in those exposed to high doses of anthracyclines during childhood cancer treatment. It includes lab biomarker analysis, pharmacogenomic and pharmacological studies, placebo comparison, quality-of-life assessment, and questionnaires.
How Is the Trial Designed?
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Arm I (carvedilol)Experimental Treatment6 Interventions
Group II: Arm II (placebo)Placebo Group6 Interventions

Carvedilol is already approved in United States, European Union, Canada, Japan for the following indications:

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Approved in United States as Coreg for:
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Approved in European Union as Dilatrend for:
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Approved in Canada as Eucardic for:
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Approved in Japan as Carloc for:

Find a Clinic Near You

Who Is Running the Clinical Trial?

Children's Oncology Group

Lead Sponsor

Trials
467
Recruited
241,000+

National Cancer Institute (NCI)

Collaborator

Trials
14,080
Recruited
41,180,000+
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