NCT00268047

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
50

participants targeted

Target at P25-P50 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 20, 2005

Completed
2 days until next milestone

First Posted

Study publicly available on registry

December 22, 2005

Completed
Last Updated

July 6, 2011

Status Verified

July 1, 2011

First QC Date

December 20, 2005

Last Update Submit

July 5, 2011

Conditions

Congenital Disorders

Keywords

pediatriccardiacsurgerytransplantationpulmonary vascular resistance in Fontan patients

Eligibility Criteria

AgeUp to 21 Years
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64)
Sampling MethodNon-Probability Sample
Study Population

retro chart review

You may qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Children's Healthcare of Atlanta

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Conditions

Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Study Officials

  • Kirk R. Kanter, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

December 20, 2005

First Posted

December 22, 2005

Last Updated

July 6, 2011

Record last verified: 2011-07

Locations

US(1)