CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 196 enrolled
Drug / intervention
Carvedilol +6 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02717507
NCT02717507Phase 2Completed

Pharmacologic Reversal of Ventricular Remodeling in Childhood Cancer Survivors at Risk for Heart Failure (PREVENT-HF): A Phase 2b Randomized Placebo-Controlled (Carvedilol) Trial

Children's Oncology Group·interventional·Posted Mar 23, 2016·Updated Apr 23, 2025

In Brief

A Phase 2 clinical trial evaluating Carvedilol, Laboratory Biomarker Analysis, and 5 other interventions for Hematopoietic and Lymphoid Cell Neoplasm and Malignant Solid Neoplasm. Completed, enrolled 196 participants across 91 sites in 4 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustralia, Canada, New Zealand, United States

Timeline

Phase 2CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 23, 2016
Enrollment StartApr 4, 2016
Primary CompletionJun 30, 2022
Study CompletionMar 31, 2025
TodayJul 2, 2026
Enrollment to primary: 6.2 yearsPosted 10.3 years ago

Interventions

Carvediloldrug

Given PO

Laboratory Biomarker Analysisother

Correlative studies

Pharmacogenomic Studyother

Correlative studies

Pharmacological Studyother

Correlative studies

Placebo Administrationother

Given PO

Quality-of-Life Assessmentother

Ancillary studies

Questionnaire Administrationother

Ancillary studies