Ignite Creation Date:
2024-05-05 @ 11:47 AM
Last Modification Date:
2024-10-26 @ 9:13 AM
Study NCT ID:
NCT00132782
Status:
COMPLETED
Last Update Posted:
2014-03-04
First Post:
2005-08-19
Brief Title:
Relationship Between Functional Health Status and Ventricular Performance After Fontan--Pediatric Heart Network
Sponsor:
Carelon Research
Organization:
Carelon Research
Study Overview
Official Title:
Relationship Between Functional Health Status and Ventricular Performance After Fontan A Trial Conducted by the Pediatric Heart Network
Status:
COMPLETED
Status Verified Date:
2009-02
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:
The purpose of this cross-sectional study was to determine the interrelationships between health status and measures of cardiac performance in children 6 to 18 years of age with congenital heart disease who have undergone a Fontan procedure as surgical treatment for functional single ventricle The goal was to develop a data set that will permit identification of a clinically relevant endpoint for subsequent trials of medical management of the Fontan patient
Detailed Description:
BACKGROUND
Children born with one functional ventricle and who undergo a Fontan procedure have a higher incidence of late complications than other congenital heart patients While the Fontan procedure results in restoring near-normal systemic oxygen saturation there are recognized problems and little information about the overall health status functional status and ventricular performance in these children
DESIGN NARRATIVE
This cross-sectional observational study included children 6-18 years of age who had undergone a Fontan procedure for a congenital cardiac defect Prospective data collection for each patient occured within a 3 month time period and included cardiac MRI echocardiography serology and exercise testing Historical clinical and surgical data as well as parent and child self reports of health status was collected
Children born with one functional ventricle and who undergo a Fontan procedure have a higher incidence of late complications than other congenital heart patients While the Fontan procedure results in restoring near-normal systemic oxygen saturation there are recognized problems and little information about the overall health status functional status and ventricular performance in these children
DESIGN NARRATIVE
This cross-sectional observational study included children 6-18 years of age who had undergone a Fontan procedure for a congenital cardiac defect Prospective data collection for each patient occured within a 3 month time period and included cardiac MRI echocardiography serology and exercise testing Historical clinical and surgical data as well as parent and child self reports of health status was collected
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| U01HL068270 | NIH | None | httpsreporternihgovquickSearchU01HL068270 |