NCT00478296|Completed
Pulmonary Hypertension in Trisomy 21 Patients
Case Report: Resolution of Pulmonary Hypertension With Sildenafil and Bosentan in Patients With Trisomy 21 and Atrial Septal Defect
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Case Report: Resolution of Pulmonary Hypertension With Sildenafil and Bosentan in Patients With Trisomy 21 and Atrial Septal Defect
Sponsor study identifier
observational
1
1 country
1
Study Start
October 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2007
Actual (reported)Study Completion
March 2008
Actual (reported)Evidence has shown poor outcome for adult patients with pre-operative pulmonary hypertension following closure of an atrial septal defect. Life-threatening pulmonary hypertensive crises may occur in these patients when they no longer have an atrial communication to decompress high right heart pressures. This concern has led some to advocate fenestrated patch closure of ASDs in patients with pulmonary hypertension with the prospect of a repeated procedure in order to close the fenestrations at a later date.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
March 2008
Actual (reported)Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
October 2004
Date type not reportedThis date has not been verified as actual or estimated.
February 2007
Actual (reported)May 22, 2007
Actual (reported)May 24, 2007
Actual (reported)March 2008
Actual (reported)This is a case report of one subject with trisomy 21 and a primum atrial septum defect with associated cleft mitral valve who was diagnosed with pulmonary hypertension at 8 days of life.
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Children's Healthcare of Atlanta
Atlanta, Georgia, 30322, United States
Heather M Phelps, DO
Children's Healthcare of Atlanta
1 participants (actual enrollment reported by the registry).
First Submitted
May 22, 2007
First Posted
May 24, 2007
Study Start
October 2004
Date type not reportedThis date has not been verified as actual or estimated.
Primary Completion
February 2007
Actual (reported)Study Completion
March 2008
Actual (reported)Last Updated
March 16, 2012
Record last verified: 2008-01
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