Status:
COMPLETED
Relationship Between Functional Health Status and Ventricular Performance After Fontan--Pediatric Heart Network
Lead Sponsor:
Carelon Research
Collaborating Sponsors:
National Heart, Lung, and Blood Institute (NHLBI)
Pediatric Heart Network
Conditions:
Defect, Congenital Heart
Arrhythmia
Eligibility:
All Genders
6-18 years
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 disea...
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 proced...
Eligibility Criteria
Inclusion
- 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:
- An echocardiogram at the study center,
- Parent health status questionnaire, and
- 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.
Exclusion
Key Trial Info
Start Date :
March 1 2003
Trial Type :
OBSERVATIONAL
Allocation :
ACTUAL
End Date :
April 1 2004
Estimated Enrollment :
546 Patients enrolled
Trial Details
Trial ID
NCT00132782
Start Date
March 1 2003
End Date
April 1 2004
Last Update
March 4 2014
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