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Tracking Information | |||||
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First Received Date † | December 20, 2005 | ||||
Last Updated Date | May 2, 2007 | ||||
Start Date † | |||||
Current Primary Outcome Measures † | |||||
Original Primary Outcome Measures † | |||||
Change History | Complete list of historical versions of study NCT00268047 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † | |||||
Original Secondary Outcome Measures † | |||||
Descriptive Information | |||||
Brief Title † | Pulmonary Resistance in Fontan Who Have Undergone Heart Transplantation | ||||
Official Title † | Retrospective Assessment of Pulmonary Vascular Resistance in Fontan Patients Who Have Undergone Orthotopic Heart Transplantation | ||||
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. |
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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.
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Study Phase | |||||
Study Type † | Observational | ||||
Study Design † | Natural History, Longitudinal, Defined Population, Retrospective Study | ||||
Condition † | Congenital Disorders | ||||
Intervention † | |||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Terminated | ||||
Enrollment † | 50 | ||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
Exclusion Criteria:
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Gender | Both | ||||
Ages | up to 21 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00268047 | ||||
Responsible Party | |||||
Secondary IDs †† | |||||
Study Sponsor † | Children's Healthcare of Atlanta | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Children's Healthcare of Atlanta | ||||
Verification Date | May 2007 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |