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.

Study Overview

• Status: Terminated
• Conditions: 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
• Enrollment (Actual): 50

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: No older than 21 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

retro chart review

Description

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

Study Plan

How is the study designed?

Collaborators and Investigators

• Sponsor: Children's Healthcare of Atlanta
• Investigators: Principal Investigator: Kirk R. Kanter, MD, Emory Univ. SOM Cardiothoracic Surgery at Children's Healthcare of Atlanta

Study record dates

Study Registration Dates

• First Submitted: December 20, 2005
• First Submitted That Met QC Criteria: December 20, 2005
• First Posted (Estimate): December 22, 2005

Study Record Updates

• Last Update Posted (Estimate): July 6, 2011
• Last Update Submitted That Met QC Criteria: July 5, 2011
• Last Verified: July 1, 2011

More Information

Terms related to this study

• Keywords: pediatric; surgery; transplantation; cardiac; pulmonary vascular resistance in Fontan patients
• Other Study ID Numbers: 03-068