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

December 20, 2005
July 5, 2011
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Complete list of historical versions of study NCT00268047 on ClinicalTrials.gov Archive Site
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Pulmonary Resistance in Fontan Who Have Undergone Heart Transplantation
Retrospective Assessment of Pulmonary Vascular Resistance in Fontan Patients Who Have Undergone Orthotopic Heart Transplantation

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.

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
Observational
Time Perspective: Retrospective
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Non-Probability Sample

retro chart review

Congenital Disorders
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
50
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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
Both
up to 21 Years
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT00268047
03-068
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Kirk R Kanter, MD, Children's Healthcare of Atlanta
Children's Healthcare of Atlanta
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Principal Investigator: Kirk R. Kanter, MD Emory Univ. SOM Cardiothoracic Surgery at Children's Healthcare of Atlanta
Children's Healthcare of Atlanta
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP