NCT00000547

Brief Summary

To determine if the chronic administration of enalapril, an inhibitor of angiotensin converting enzyme (ACE), reduces progression of cardiac dysfunction in pediatric oncology patients who have received anthracyclines, and who are not currently on digoxin, diuretics, or vasodilators for heart failure.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Timeline
Completed

Started Apr 1994

Typical duration for phase_3 cardiovascular-diseases

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 1994

Completed
5.6 years until next milestone

First Submitted

Initial submission to the registry

October 27, 1999

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 28, 1999

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2001

Completed
Last Updated

July 12, 2016

Status Verified

December 1, 2005

First QC Date

October 27, 1999

Last Update Submit

July 11, 2016

Conditions

Cardiovascular DiseasesHeart DiseasesHeart FailureMyocardial Diseases

Interventions

enalaprilDRUG

Eligibility Criteria

Age1 Year - 17 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Boy and girl pediatric oncology patients, at least two years off treatment, with some cardiac dysfunction, but not congestive heart failure, after receiving anthracyclines. Patients were not on digoxin, diuretics, or vasodilators for heart failure.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Publications (1)

  • Silber JH, Cnaan A, Clark BJ, Paridon SM, Chin AJ, Rychik J, Hogarty AN, Cohen MI, Barber G, Rutkowsky M, Kimball TR, Delaat C, Steinherz LJ, Zhao H, Tartaglione MR. Design and baseline characteristics for the ACE Inhibitor After Anthracycline (AAA) study of cardiac dysfunction in long-term pediatric cancer survivors. Am Heart J. 2001 Oct;142(4):577-85. doi: 10.1067/mhj.2001.118115.

    PMID: 11579345BACKGROUND

MeSH Terms

Conditions

Cardiovascular DiseasesHeart DiseasesHeart FailureCardiomyopathies

Interventions

Enalapril

Intervention Hierarchy (Ancestors)

DipeptidesOligopeptidesPeptidesAmino Acids, Peptides, and Proteins

Study Officials

  • Jeffrey Silber

    Children's Hospital of Philadelphia

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
DOUBLE
Purpose
TREATMENT
Sponsor Type
NIH

Study Record Dates

First Submitted

October 27, 1999

First Posted

October 28, 1999

Study Start

April 1, 1994

Study Completion

February 1, 2001

Last Updated

July 12, 2016

Record last verified: 2005-12