An observational study in Congenital Disorders, sponsored by Children's Healthcare of Atlanta. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2014-12-02.
Sponsored by Children's Healthcare of Atlanta · Observational
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.
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.
23 studies on the registry are indexed under Eisenmenger Complex; 5 are open to participants now.
Browse Eisenmenger Complex studies →Children's Healthcare of Atlanta is the lead sponsor of 97 studies on the registry; 6 are open to participants now.
Compared within Eisenmenger Complex, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Congenital, Hereditary, and Neonatal Diseases and Abnormalities. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Congenital heart disease (unoperated, palliated or repaired) Eisenmenger's syndrome Age 18 to 80
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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
Our study demonstrates that endothelin receptor blockers can be used to improve exercise tolerance, oxygenation, and functional status in adults with Eisenmenger syndrome without adverse effects. The role of newer treatment modalities such as prostacyclins, PDE inhibitors, and nitric oxide remain promising and their role needs to be investigated to help improve quality of life and life expectancy in these patients.
Time frame: 12 years
The record gives a start of Jan 1996, a primary completion of Jan 2008 and a completion of Jan 2008. It does not say whether these dates are actual or estimated.
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This study is completed, as verified in Nov 2014. You cannot join it, but the record below documents what was studied.
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Children's Healthcare of Atlanta