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
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Condition or disease | Intervention/treatment | Phase |
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Cardiovascular Diseases Heart Diseases Heart Failure Myocardial Diseases | Drug: enalapril | Phase 3 |
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 Type : | Interventional (Clinical Trial) |
Allocation: | Randomized |
Masking: | Double |
Primary Purpose: | Treatment |
Study Start Date : | April 1994 |
Actual Study Completion Date : | February 2001 |


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

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
OverallOfficial: | Jeffrey Silber | Children's Hospital of Philadelphia |
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 |
Cardiovascular Diseases Heart Diseases Cardiomyopathies Enalapril Angiotensin-Converting Enzyme Inhibitors |
Protease Inhibitors Enzyme Inhibitors Molecular Mechanisms of Pharmacological Action Antihypertensive Agents |