Pulmonary Resistance in Fontan Who Have Undergone Heart Transplantation - Full Text View

Sponsored by:	Children's Healthcare of Atlanta
Information provided by:	Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier:	NCT00268047

Purpose

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.

Condition
Congenital Disorders

MedlinePlus related topics: Heart Transplantation Surgery

U.S. FDA Resources

Study Type:	Observational
Study Design:	Natural History, Longitudinal, Defined Population, Retrospective Study
Official Title:	Retrospective Assessment of Pulmonary Vascular Resistance in Fontan Patients Who Have Undergone Orthotopic Heart Transplantation

Further study details as provided by Children's Healthcare of Atlanta:

Estimated Enrollment:

50

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

Eligibility

Ages Eligible for Study:	up to 21 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

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

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00268047

Locations

United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322

Sponsors and Collaborators

Children's Healthcare of Atlanta

Investigators

Principal Investigator:

Kirk R. Kanter, MD

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

More Information

No publications provided

Study ID Numbers:	03-068
Study First Received:	December 20, 2005
Last Updated:	May 2, 2007
ClinicalTrials.gov Identifier:	NCT00268047 History of Changes
Health Authority:	United States: Food and Drug Administration

Keywords provided by Children's Healthcare of Atlanta:

pediatric
cardiac
surgery
transplantation
pulmonary vascular resistance in Fontan patients

ClinicalTrials.gov processed this record on May 06, 2009