Pulmonary Resistance in Fontan Who Have Undergone Heart Transplantation

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00268047
Recruitment Status : Terminated
First Posted : December 22, 2005
Last Update Posted : July 6, 2011
Information provided by:
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.

Condition or disease
Congenital Disorders

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 Type : Observational
Actual Enrollment : 50 participants
Time Perspective: Retrospective
Official Title: Retrospective Assessment of Pulmonary Vascular Resistance in Fontan Patients Who Have Undergone Orthotopic Heart Transplantation

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Information from the National Library of Medicine

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Ages Eligible for Study:   up to 21 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
retro chart review

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00268047

United States, Georgia
Children's Healthcare of Atlanta
Atlanta, Georgia, United States, 30322
Sponsors and Collaborators
Children's Healthcare of Atlanta
Principal Investigator: Kirk R. Kanter, MD Emory Univ. SOM Cardiothoracic Surgery at Children's Healthcare of Atlanta

Responsible Party: Kirk R Kanter, MD, Children's Healthcare of Atlanta Identifier: NCT00268047     History of Changes
Other Study ID Numbers: 03-068
First Posted: December 22, 2005    Key Record Dates
Last Update Posted: July 6, 2011
Last Verified: July 2011

Keywords provided by Children's Healthcare of Atlanta:
pulmonary vascular resistance in Fontan patients