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

Arrhythmia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00132782
• Other study ID #: 242
• Secondary ID: U01HL068270
• Status: Completed
• Phase: N/A
• First received: August 19, 2005
• Last updated: March 3, 2014
• Start date: March 2003
• Est. completion date: April 2004

Study information

• Verified date: February 2009
• Source: New England Research Institutes
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Federal Government
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 546
• Est. completion date: April 2004
• Est. primary completion date: April 2004
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 6 Years to 18 Years

Eligibility

Inclusion Criteria

• Age 6 through 18 years at the time of enrollment.

• Fontan surgery of any type at least 6 months prior to the time of testing.

• Agreement and ability to have all of the following testing completed:

1. An echocardiogram at the study center,

2. Parent health status questionnaire, and

3. Blood testing.

• Planned or ongoing cardiac care at the study center that will allow completion of study testing within 3 months of study enrollment.

• Informed consent of a parent or guardian, and assent of the study participant if he/she is able to provide it, according to institutional guidelines.

Exclusion Criteria

• Non-cardiac medical or psychiatric disorder that would prevent successful completion of planned study testing or would invalidate the results of study testing.

• Ongoing or planned participation in another research protocol that would either prevent successful completion of planned study testing or invalidate the results of study testing.

• Lack of reading fluency by the primary caregiver in both English and Spanish, languages for which the parental report health status questionnaire has been validated.

• Pregnancy at the time of enrollment or pregnancy planned prior to completion of study testing.

Study Design

Observational Model: Case-Crossover, Time Perspective: Prospective

Related Conditions & MeSH terms

• Arrhythmia
• Congenital Abnormalities
• Defect, Congenital Heart
• Heart Defects, Congenital

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
New England Research Institutes	National Heart, Lung, and Blood Institute (NHLBI), Pediatric Heart Network