Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-26 @ 1:35 AM
Study NCT ID:
NCT01976533
Status:
UNKNOWN
Last Update Posted:
2015-12-24
First Post:
2013-10-29
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Eisenmenger Syndrome in the Nordic Countries
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004541', 'term': 'Eisenmenger Complex'}], 'ancestors': [{'id': 'D006330', 'term': 'Heart Defects, Congenital'}, {'id': 'D018376', 'term': 'Cardiovascular Abnormalities'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D000013', 'term': 'Congenital Abnormalities'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 714}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2012-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2016-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-12-23', 'studyFirstSubmitDate': '2013-10-29', 'studyFirstSubmitQcDate': '2013-10-29', 'lastUpdatePostDateStruct': {'date': '2015-12-24', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-11-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All cause mortality', 'timeFrame': '10 years'}]}, 'oversightModule': {'oversightHasDmc': True}, 'conditionsModule': {'conditions': ['Eisenmenger Syndrome']}, 'descriptionModule': {'briefSummary': "This is a historical cohort study with retrospective collection of data comprising all Nordic patient's diagnosed with Eisenmengers syndrome in the period 1977 through 2011. The goal is to determine prognostic factors for mortality and morbidity.", 'detailedDescription': 'The following variables are obtained from national registries for each individual fulfilling the inclusion criteria:\n\n* Personal data: Gender, day of birth, vital status (dead/alive), date of death, cause of death, all cause hospitalization days\n* Specific cardiac malformation diagnosis\n* Heart-lung transplantation.\n* Social data: Highest educational level, marital status, employment status (Denmark only)\n\nPrimary endpoints\n\n* Incidence and prevalence of Eisenmenger Syndrome\n* All-cause mortality\n* All-cause morbidity (hospitalization for any cause)\n* Heart-lung transplantation\n* Advanced treatment\n* Mortality with AT\n* Highest educational level\n* Personal income\n* Marital status\n* Job status'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Nordic patients with Eisnemnger syndrome', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Eisenmenger syndrome\n\nExclusion Criteria:\n\n\\-'}, 'identificationModule': {'nctId': 'NCT01976533', 'briefTitle': 'Eisenmenger Syndrome in the Nordic Countries', 'organization': {'class': 'OTHER', 'fullName': 'Rigshospitalet, Denmark'}, 'officialTitle': 'Eisenmenger Syndrome in the Nordic Countries: Advanced Treatment and Mortality 1977-2012', 'orgStudyIdInfo': {'id': '3-3013-144/1/'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Advanced therapy, Heart-lung transplantation, dead'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Copenhagen', 'country': 'Denmark', 'facility': 'Dept. Cardiology B, Rigshospitalet', 'geoPoint': {'lat': 55.67594, 'lon': 12.56553}}, {'city': 'Various', 'country': 'Finland', 'facility': 'Centers for Adult Congenital Heart Disease'}, {'city': 'Various', 'country': 'Norway', 'facility': 'Centers for Adult Congenital Heart Disease'}, {'city': 'Various', 'country': 'Sweden', 'facility': 'Centers for adult congenital heart disease'}], 'overallOfficials': [{'name': 'Lars Soendergaard, MD, DMSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Rigshospitalet, Denmark'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rigshospitalet, Denmark', 'class': 'OTHER'}, 'collaborators': [{'name': 'Lund University Hospital', 'class': 'OTHER'}, {'name': 'Rikshospitalet University Hospital', 'class': 'OTHER'}, {'name': 'Hospital for Children and Adolescents, Finland', 'class': 'OTHER'}, {'name': 'Actelion', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD', 'investigatorFullName': 'Cristel Sørensen', 'investigatorAffiliation': 'Rigshospitalet, Denmark'}}}}