NCT00132782

Relationship Between Functional Health Status and Ventricular Performance After Fontan--Pediatric Heart Network

Relationship Between Functional Health Status and Ventricular Performance After Fontan (A Trial Conducted by the Pediatric Heart Network)

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 546 (actual)
• Sponsor: Carelon Research · Academic / Other
• Sex: All
• Age: 6 Years – 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Defect, Congenital Heart
• Arrhythmia

Timeline

• Start date: 2003-03-01
• Primary completion: 2004-04-01
• Completion: 2004-04-01
• First posted: 2005-08-22
• Last updated: 2014-03-04