Enalapril After Anthracycline Cardiotoxicity

This study has been completed.
Sponsor:
Information provided by:
National Heart, Lung, and Blood Institute (NHLBI)
ClinicalTrials.gov Identifier:
NCT00000547
First received: October 27, 1999
Last updated: January 3, 2006
Last verified: December 2005
  Purpose

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 Intervention Phase
Cardiovascular Diseases
Heart Diseases
Heart Failure
Myocardial Diseases
Drug: enalapril
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Double-Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by National Heart, Lung, and Blood Institute (NHLBI):

Study Start Date: April 1994
Estimated Study Completion Date: February 2001
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.

  Eligibility

Ages Eligible for Study:   1 Year to 17 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00000547

Sponsors and Collaborators
Investigators
Investigator: Jeffrey Silber Children's Hospital of Philadelphia
  More Information

Publications:
ClinicalTrials.gov Identifier: NCT00000547     History of Changes
Other Study ID Numbers: 91
Study First Received: October 27, 1999
Last Updated: January 3, 2006
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Cardiovascular Diseases
Heart Diseases
Heart Failure
Cardiomyopathies
Enalapril
Enalaprilat
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on May 16, 2013