Enalapril After Anthracycline Cardiotoxicity

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ClinicalTrials.gov Identifier: NCT00000547

Recruitment Status : Completed

First Posted : October 28, 1999

Last Update Posted : July 12, 2016

Sponsor:

Information provided by:

National Heart, Lung, and Blood Institute (NHLBI)

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Cardiovascular Diseases Heart Diseases Heart Failure Myocardial Diseases	Drug: enalapril	Phase 3

Detailed Description:

BACKGROUND:

Pediatric oncology patients who have been treated with anthracycline therapy as a part of their chemotherapeutic regimen often subsequently develop left ventricular failure. The optimal medical management is not known. This trial will be the first to provide comprehensive data on a well characterized population regarding the role of afterload reduction using enalapril to treat ventricular dysfunction after anthracycline chemotherapy

DESIGN NARRATIVE:

Randomized, double-blind. Randomization was stratified by total anthracycline dose, follow-up time from treatment, and age at time of treatment. All patients received the following baseline tests: Maximal Cardiac Index (MCI) on cycle ergometry; echocardiogram/Doppler determined left ventricular end systolic wall stress (ESWS); gated nuclear angiography (GNA) to determine left ventricular ejection fraction; Holter monitoring for 24 hour ECG monitoring. Patients were randomized to either enalapril or placebo. Follow-up visits were conducted to ensure compliance and screen for side effects. MCI and ESWS were measured twice yearly, while all four tests were repeated at the conclusion of the trial, after four to five years of treatment. The primary outcome variables were the rate of decline in MCI and the rate of increase in ESWS. Secondary outcomes were the change in left ventricular ejection fraction and the incidence of arrhythmias. A second aim of the study was to develop an algorithm to determine indications for enalapril use if the study succeeded in showing a treatment effect. This required modeling the probability of cardiac dysfunction given patient characteristics at treatment, treatment type, cardiac status during treatment and at follow-up, and the development of cost effectiveness and medical decision making models testing the proposed algorithm.

The study completion date listed in this record was obtained from the "Completed Date" entered in the Query View Report System (QVR).

Study Design

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Study Type :	Interventional (Clinical Trial)
Allocation:	Randomized
Masking:	Double
Primary Purpose:	Treatment
Study Start Date :	April 1994
Actual Study Completion Date :	February 2001

Resource links provided by the National Library of Medicine

Drug Information available for: Enalapril Enalapril maleate Enalaprilat

U.S. FDA Resources

Arms and Interventions

Outcome Measures

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:	1 Year to 17 Years (Child)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	No

Criteria

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.

Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00000547

Sponsors and Collaborators

National Heart, Lung, and Blood Institute (NHLBI)

Investigators

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OverallOfficial:	Jeffrey Silber	Children's Hospital of Philadelphia

More Information

Publications:

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.

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ClinicalTrials.gov Identifier:	NCT00000547
Other Study ID Numbers:	91
First Posted:	October 28, 1999 Key Record Dates
Last Update Posted:	July 12, 2016
Last Verified:	December 2005

Additional relevant MeSH terms:

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Cardiovascular Diseases Heart Diseases Cardiomyopathies Enalapril Angiotensin-Converting Enzyme Inhibitors	Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antihypertensive Agents

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