Pulmonary Resistance in Fontan Who Have Undergone Heart Transplantation - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

December 20, 2005

Last Updated Date

May 2, 2007

Start Date ^†

Current Primary Outcome Measures ^†

Original Primary Outcome Measures ^†

Change History

Complete list of historical versions of study NCT00268047 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Pulmonary Resistance in Fontan Who Have Undergone Heart Transplantation

Official Title ^†

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

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.

Diagnosis
Surgical History
Information from Pre-transplant evaluation
Post-transplant hemodynamics
Post-transplant catheterization results

Study Phase

Study Type ^†

Observational

Study Design ^†

Natural History, Longitudinal, Defined Population, Retrospective Study

Condition ^†

Congenital Disorders

Intervention ^†

Study Arms / Comparison Groups

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Terminated

Enrollment ^†

Completion Date

Primary Completion Date

Eligibility Criteria ^†

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

Gender

Both

Ages

up to 21 Years

Accepts Healthy Volunteers

Contacts ^††

Location Countries ^†

United States

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00268047

Responsible Party

Secondary IDs ^††

Study Sponsor ^†

Children's Healthcare of Atlanta

Collaborators ^††

Investigators ^†

Principal Investigator:

Kirk R. Kanter, MD

Emory Univ. SOM Cardiothoracic Surgery at Children's Healthcare of Atlanta

Information Provided By

Children's Healthcare of Atlanta

Verification Date

May 2007

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.