Ignite Creation Date:
2025-12-24 @ 9:40 PM
Ignite Modification Date:
2026-01-01 @ 10:06 AM
Study NCT ID:
NCT01948232
Status:
WITHDRAWN
Last Update Posted:
2015-10-06
First Post:
2013-09-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pilot Study of Perindopril in Childhood Cancer Survivors
Sponsor:
The Hospital for Sick Children
Organization:
Study Overview
Official Title:
A Phase II Open Label Pilot Study of the Angiotensin-converting Enzyme Inhibitor, Perindopril, in Pediatric Cancer Survivors With Evidence of Early Cardiac Remodelling or Dysfunction.
Status:
WITHDRAWN
Status Verified Date:
2015-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
no participants enrolled
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The purpose of this study is to evaluate the feasibility of conducting a medical intervention trial in childhood cancer survivors with early echocardiographic evidence of cardiac remodeling.
Detailed Description:
Anthracycline cardiotoxicity is characterized by ventricular remodeling and progressive cardiac dysfunction. Since ventricular remodeling in other types of heart failure can be treated effectively with an angiotensin-converting enzyme inhibitor (ACEi), these agents would appear a logical therapy in children with anthracycline-induced heart failure. Previous experience with ACEi in childhood cancer survivors has shown mixed results, possibly due to the fact that treatment is initiated too late in the natural history of the disease. Providing treatment in childhood cancer survivors with early signs of cardiac remodeling may be more effective than treating children who have global dysfunction. The benefits of early intervention are unclear, so it is unclear whether CCS and their parents will be willing to receive treatment where the target outcome (prevention of decreased global function or congestive heart failure) may not occur for years after the intervention. Assessing the feasibility of this pre-emptive approach is the primary aim of the study.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: