Ignite Creation Date:
2025-12-24 @ 7:32 PM
Ignite Modification Date:
2025-12-25 @ 5:14 PM
Study NCT ID:
NCT00266903
Status:
COMPLETED
Last Update Posted:
2014-12-02
First Post:
2005-12-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Eisenmenger's Syndrome in Adults With CHD
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}, {'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D004541', 'term': 'Eisenmenger Complex'}], 'ancestors': [{'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '1996-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2014-11', 'completionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2014-11-26', 'studyFirstSubmitDate': '2005-12-19', 'studyFirstSubmitQcDate': '2005-12-19', 'lastUpdatePostDateStruct': {'date': '2014-12-02', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2005-12-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2008-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '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', 'timeFrame': '12 years', 'description': '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.'}]}, 'conditionsModule': {'keywords': ['adult', 'congenital heart disease', "Eisenmenger's Syndrome", 'Bosentan', 'Sitaxsetan', 'Sildenafil'], 'conditions': ['Congenital Disorders']}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': "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."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Congenital heart disease (unoperated, palliated or repaired) Eisenmenger's syndrome Age 18 to 80", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Congenital heart disease (unoperated, palliated or repaired) Eisenmenger's syndrome Age 18 to 80\n\nExclusion Criteria:\n\n* Those who do not meet inclusion criteria"}, 'identificationModule': {'nctId': 'NCT00266903', 'briefTitle': "Eisenmenger's Syndrome in Adults With CHD", 'organization': {'class': 'OTHER', 'fullName': "Children's Healthcare of Atlanta"}, 'officialTitle': "Treatment of Eisenmenger's Syndrome in Adults With Congenital Heart Disease With Pulmonary Arterial Vasodilators", 'orgStudyIdInfo': {'id': '05-118'}}, 'contactsLocationsModule': {'locations': [{'zip': '30322', 'city': 'Atlanta', 'state': 'Georgia', 'country': 'United States', 'facility': "Children's Healthcare of Atlanta", 'geoPoint': {'lat': 33.749, 'lon': -84.38798}}], 'overallOfficials': [{'name': 'Wendy M. Book, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Emory University SOM'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Children's Healthcare of Atlanta", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}