This trial is active, not recruiting.

Condition congenital disorders
Sponsor Children's Healthcare of Atlanta
Start date January 1996
Trial size 70 participants
Trial identifier NCT00266903, 05-118


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Time perspective retrospective

Eligibility Criteria

Male or female participants at least 18 years old.

Inclusion Criteria: - Congenital heart disease (unoperated, palliated or repaired) Eisenmenger's syndrome Age 18 to 80 Exclusion Criteria: - Those who do not meet inclusion criteria

Additional Information

Official title Treatment of Eisenmenger's Syndrome in Adults With Congenital Heart Disease With Pulmonary Arterial Vasodilators
Principal investigator Wendy M. Book, MD
Description 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.
Trial information was received from ClinicalTrials.gov and was last updated in March 2012.
Information provided to ClinicalTrials.gov by Children's Healthcare of Atlanta.