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Carvedilol in Preventing Heart Failure in Childhood Cancer Survivors

NCT02717507 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 196

Last updated 2025-04-23

Study results available
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Summary

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.

Conditions

  • Hematopoietic and Lymphoid Cell Neoplasm
  • Malignant Solid Neoplasm

Interventions

DRUG

Carvedilol

Given PO

OTHER

Laboratory Biomarker Analysis

Correlative studies

OTHER

Pharmacogenomic Study

Correlative studies

OTHER

Pharmacological Study

Correlative studies

OTHER

Placebo Administration

Given PO

OTHER

Quality-of-Life Assessment

Ancillary studies

OTHER

Questionnaire Administration

Ancillary studies

Sponsors & Collaborators

  • National Cancer Institute (NCI)

    collaborator NIH

  • Children's Oncology Group

    lead NETWORK

Principal Investigators

  • Saro H Armenian · Children's Oncology Group

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
DOUBLE
Model
PARALLEL

Eligibility

Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2016-04-04
Primary Completion
2022-06-30
Completion
2025-03-31
FDA Drug
Yes

Countries

  • United States
  • Australia
  • Canada
  • New Zealand

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02717507 on ClinicalTrials.gov