Pulmonary Resistance in Fontan Who Have Undergone Heart Transplantation

Terminated

• Conditions: Congenital Disorders

• Registration Number: NCT00268047
• Lead Sponsor: Children's Healthcare of Atlanta

Brief Summary

Clinical evidence reveals that some patients who undergo cardiac transplantation exhibit problems with pulmonary vascular resistance as well. In some studies, an increase in pulmonary vascular resistance has been used as an indicator for increased 3-day and 3-month mortality after heart transplantation2. In this study, the investigators would like to look at pulmonary vascular resistance in patients with a surgical history of the Fontan procedure followed by heart transplantation.

Detailed Description

Children born with certain congenital heart diseases such as tricuspid atresia or single ventricle physiology normally undergo the Fontan procedure during their course of treatment. The Fontan procedure however is palliative and some of these children will eventually require heart transplantation. It has been shown in pre-clinical animal models that pulmonary vascular resistance actually increases after having the Fontan procedure however this has not been quantitated in the human population.1

This is a retrospective chart review with the primary objective of examining Fontan patients with pulmonary vascular resistance and who have undergone heart transplantation. We will review 50 charts at Children's Healthcare of Atlanta, Egleston Hospital. Three other United States' sites are participating. All de-identified data will be forwarded to the Great Ormond Street Hospital in London, England for study analysis. In order to ascertain this objective, the following data will be collected.

1. Diagnosis

2. Surgical History

3. Information from Pre-transplant evaluation

4. Post-transplant hemodynamics

5. Post-transplant catheterization results

Study Timeline

• Study First Submitted: 2005-12-20
• Study First Submitted QC: 2005-12-20
• Study First Posted: 2005-12-22
• Status Verified: 2011-07
• Last Update Submitted: 2011-07-05
• Last Update Posted: 2011-07-06

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• patients who have undergone the Fontan procedure
• patients cared for at Children's Healthcare of Atlanta
• Patients who have undergone a heart transplantation at Children's Healthcare of Atlanta

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Exclusion Criteria

• Those patients who do meet inclusion criteria

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Trial Locations

Locations (1)

Children's Healthcare of Atlanta; 🇺🇸 Atlanta, Georgia, United States