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

March 3, 2014 updated by: HealthCore-NERI

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

546

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects must have had Fontan surgery of any type at least 6 months prior to the time of testing

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Case-Crossover
  • Time Perspectives: Prospective

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

HealthCore-NERI

Collaborators

National Heart, Lung, and Blood Institute (NHLBI)
Pediatric Heart Network

Investigators

  • Principal Investigator: Lynn Sleeper, ScD, HealthCore-NERI

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2003

Primary Completion (Actual)

April 1, 2004

Study Completion (Actual)

April 1, 2004

Study Registration Dates

First Submitted

August 19, 2005

First Submitted That Met QC Criteria

August 19, 2005

First Posted (Estimate)

August 22, 2005

Study Record Updates

Last Update Posted (Estimate)

March 4, 2014

Last Update Submitted That Met QC Criteria

March 3, 2014

Last Verified

February 1, 2009

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 242
  • U01HL068270 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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