Ignite Creation Date:
2024-05-05 @ 11:19 AM
Last Modification Date:
2024-10-26 @ 9:01 AM
Study NCT ID:
NCT00000547
Status:
COMPLETED
Last Update Posted:
2016-07-12
First Post:
1999-10-27
Brief Title:
Enalapril After Anthracycline Cardiotoxicity
Sponsor:
National Heart Lung and Blood Institute NHLBI
Organization:
National Heart Lung and Blood Institute NHLBI
Study Overview
Official Title:
None
Status:
COMPLETED
Status Verified Date:
2005-12
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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
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 echocardiogramDoppler 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
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 echocardiogramDoppler 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 Oversight
Has Oversight DMC:
Is a FDA Regulated Drug?:
Is a FDA Regulated Device?:
Is an Unapproved Device?:
Is a PPSD?:
Is a US Export?:
Is an FDA AA801 Violation?: