Ignite Creation Date:
2024-05-05 @ 12:10 PM
Last Modification Date:
2024-10-26 @ 9:21 AM
Study NCT ID:
NCT00266903
Status:
COMPLETED
Last Update Posted:
2014-12-02
First Post:
2005-12-19
Brief Title:
Eisenmengers Syndrome in Adults With CHD
Sponsor:
Childrens Healthcare of Atlanta
Organization:
Childrens Healthcare of Atlanta
Study Overview
Official Title:
Treatment of Eisenmengers Syndrome in Adults With Congenital Heart Disease With Pulmonary Arterial Vasodilators
Status:
COMPLETED
Status Verified Date:
2014-11
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
Review the outcome of treatment with endothelin receptor antagonists bosentan or sitaxsetan alone or in combination with Sildenafil a PDE-5 inhibitor in adult patients with pulmonary hypertension due to congenital heart disease
Detailed Description:
The primary objective of this study is to examine medical records of patients with Eisenmengers Syndrome in order to determine the effect of endothelin receptor antagonists alone or in combination with Sildenafil on symptoms of pulmonary hypertension This review will be conducted on Standard of Care procedures such as New York Heart Association NYHA classification six-minute walk exercise capacity pulmonary pressures and oxygens saturations Pulmonary pressures determined by echo or cardiac catheterization will be analyzed where available We hypothesize that patients with congenital heart defects who develop ES will have an improved six-minute walk distance improved pulmonary arterial pressures and improved oxygenation after treatment with endothelin receptor antagonists and other pulmonary vasodilators
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None