Arrhythmia Clinical Trial
Official title:
Relationship Between Functional Health Status and Ventricular Performance After Fontan (A Trial Conducted by the Pediatric Heart Network)
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 |
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.
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. |
Observational Model: Case-Crossover, Time Perspective: Prospective
Country | Name | City | State |
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n/a |
Lead Sponsor | Collaborator |
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New England Research Institutes | National Heart, Lung, and Blood Institute (NHLBI), Pediatric Heart Network |
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