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Sponsored by: |
Children's Healthcare of Atlanta |
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Information provided by: | Children's Healthcare of Atlanta |
ClinicalTrials.gov Identifier: | NCT00266903 |
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.
Condition |
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Congenital Disorders |
Study Type: | Observational |
Study Design: | Natural History, Longitudinal, Defined Population, Retrospective Study |
Official Title: | Treatment of Eisenmenger's Syndrome in Adults With Congenital Heart Disease With Pulmonary Arterial Vasodilators |
Estimated Enrollment: | 70 |
Study Start Date: | January 1996 |
The primary objective of this study is to examine medical records of patients with Eisenmenger’s 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.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Both |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
United States, Georgia | |
Children's Healthcare of Atlanta | |
Atlanta, Georgia, United States, 30322 |
Principal Investigator: | Wendy M. Book, MD | Emory University SOM |
Study ID Numbers: | 05-118 |
Study First Received: | December 19, 2005 |
Last Updated: | May 22, 2007 |
ClinicalTrials.gov Identifier: | NCT00266903 History of Changes |
Health Authority: | United States: Institutional Review Board |
adult congenital heart disease Eisenmenger's Syndrome |
Bosentan Sitaxsetan Sildenafil |
Eisenmenger Complex Vasodilator Agents Eisenmenger Syndrome Heart Diseases Cardiovascular Abnormalities |
Sildenafil Congenital Abnormalities Heart Defects, Congenital Bosentan |
Eisenmenger Complex Pathologic Processes Disease Heart Diseases Cardiovascular Abnormalities |
Syndrome Cardiovascular Diseases Congenital Abnormalities Heart Defects, Congenital |