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NCT00268047 Clinical Trial

Pulmonary Resistance in Fontan Who Have Undergone Heart Transplantation

Congenital Disorders Clinical Trial

Official title:
Retrospective Assessment of Pulmonary Vascular Resistance in Fontan Patients Who Have Undergone Orthotopic Heart Transplantation

Clinical Trial Details — Status: Terminated

Administrative data
NCT number NCT00268047
Other study ID # 03-068
Secondary ID
Status Terminated
Phase N/A
First received December 20, 2005
Last updated July 5, 2011

Study information
Verified date July 2011
Source Children's Healthcare of Atlanta
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Observational

Clinical Trial 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.

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

Recruitment information / eligibility
Status Terminated
Enrollment 50
Est. completion date
Est. primary completion date
Accepts healthy volunteers No
Gender Both
Age group N/A to 21 Years
Eligibility 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

Exclusion Criteria:

- Those patients who do meet inclusion criteria

Study Design

Time Perspective: Retrospective

Related Conditions & MeSH terms

Locations
Country Name City State
United States Children's Healthcare of Atlanta Atlanta Georgia

Sponsors (1)
Lead Sponsor Collaborator
Children's Healthcare of Atlanta

Country where clinical trial is conducted

United States, 

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