Pulmonary Resistance in Fontan Who Have Undergone Heart Transplantation

This study has been terminated.
Sponsor:
Information provided by:
Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier:
NCT00268047
First received: December 20, 2005
Last updated: July 5, 2011
Last verified: July 2011
  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

Study Type: Observational
Study Design: Time Perspective: Retrospective
Official Title: Retrospective Assessment of Pulmonary Vascular Resistance in Fontan Patients Who Have Undergone Orthotopic Heart Transplantation

Resource links provided by NLM:


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

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.

  1. Diagnosis
  2. Surgical History
  3. Information from Pre-transplant evaluation
  4. Post-transplant hemodynamics
  5. Post-transplant catheterization results
  Eligibility

Ages Eligible for Study:   up to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

retro chart review

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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

Responsible Party: Kirk R Kanter, MD, Children's Healthcare of Atlanta
ClinicalTrials.gov Identifier: NCT00268047     History of Changes
Other Study ID Numbers: 03-068
Study First Received: December 20, 2005
Last Updated: July 5, 2011
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 July 29, 2014