Ignite Creation Date:
2025-12-24 @ 10:22 PM
Ignite Modification Date:
2025-12-28 @ 2:13 PM
Study NCT ID:
NCT01387035
Status:
RECRUITING
Last Update Posted:
2022-07-14
First Post:
2011-06-29
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Early Diagnosis of Pulmonary Hypertension in Patients With Inflammatory Rheumatic Connective Tissue Diseases
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003240', 'term': 'Connective Tissue Diseases'}, {'id': 'D006976', 'term': 'Hypertension, Pulmonary'}], 'ancestors': [{'id': 'D017437', 'term': 'Skin and Connective Tissue Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 50}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2010-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-07-12', 'studyFirstSubmitDate': '2011-06-29', 'studyFirstSubmitQcDate': '2011-07-01', 'lastUpdatePostDateStruct': {'date': '2022-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2011-07-04', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2025-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Evaluation of various screening methods for their ability to predict and to confirm PH in scleroderma patients', 'timeFrame': '3 years', 'description': 'Correlate Spiroergometric, lung functional Magnetic Resonance Imaging (MRI) and echocardiographic parameters with invasive hemodynamic findings collected by right heart catheterization: which other non-invasive parameters can be found to detect pulmonary hypertension? Can pulmonary hypertension be detected at rest in the echocardiography? In which patients can only stress-Doppler echocardiography confirm manifest or latent pulmonary hypertension? Is stress-Doppler echocardiography a suitable for early detection of pulmonary hypertension in patients with collagen vascular disease?'}], 'secondaryOutcomes': [{'measure': 'Subdivision of patients with connective tissue disease in different degrees of severity', 'timeFrame': '3 years', 'description': 'Can spiroergometric findings help to subdivide patients with connective tissue diseases into groups according to degrees of severity, and differ the patients based on spiroergometric findings? To what extent is this distinction comparable with the classifications for the "functional classes" (application for PH according to the New York Heart Association (NYHA) classification)'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Connective Tissue Disease', 'Pulmonary Hypertension']}, 'referencesModule': {'references': [{'pmid': '30615302', 'type': 'DERIVED', 'citation': 'Nagel C, Marra AM, Benjamin N, Blank N, Cittadini A, Coghlan G, Distler O, Denton CP, Egenlauf B, Fiehn C, Fischer C, Harutyunova S, Hoeper MM, Lorenz HM, Xanthouli P, Bossone E, Grunig E. Reduced Right Ventricular Output Reserve in Patients With Systemic Sclerosis and Mildly Elevated Pulmonary Artery Pressure. Arthritis Rheumatol. 2019 May;71(5):805-816. doi: 10.1002/art.40814. Epub 2019 Apr 10.'}, {'pmid': '26084934', 'type': 'DERIVED', 'citation': "Nagel C, Henn P, Ehlken N, D'Andrea A, Blank N, Bossone E, Bottger A, Fiehn C, Fischer C, Lorenz HM, Stockl F, Grunig E, Egenlauf B. Stress Doppler echocardiography for early detection of systemic sclerosis-associated pulmonary arterial hypertension. Arthritis Res Ther. 2015 Jun 19;17(1):165. doi: 10.1186/s13075-015-0673-7."}]}, 'descriptionModule': {'briefSummary': 'The purposes of this study are (I), to evaluate various screening methods for their ability to predict and to confirm Pulmonary Hypertension (PH) in scleroderma patients, and (II) to evaluate the incidence of PH (i.e. the number of new cases per year) in scleroderma patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Included are all patients who fulfill the current definition of a collagen vascular disease according to the actual guidelines of the American College of Rheumatology (ACR) and who are 18 years or older.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* consent form\n* men and women\\> 18 years\n* fulfill the current definition of a collagen vascular disease according to the actual guidelines of the American College of Rheumatology (ACR)\n\nExclusion Criteria:\n\n* all contraindications for exercise testing\n* significant restriction of the left ventricle, unstable coronary artery disease and myocardial infarction in the last 6 months\n* patients with other lung diseases (as the pulmonary infestations as part of systemic disease) or related musculoskeletal disorders influencing baseline exercise capacity\n* pregnancy'}, 'identificationModule': {'nctId': 'NCT01387035', 'briefTitle': 'Early Diagnosis of Pulmonary Hypertension in Patients With Inflammatory Rheumatic Connective Tissue Diseases', 'organization': {'class': 'OTHER', 'fullName': 'Heidelberg University'}, 'officialTitle': 'Early Diagnosis of Pulmonary Hypertension in Patients With Inflammatory Rheumatic Connective Tissue Diseases', 'orgStudyIdInfo': {'id': 'S-360/2009'}}, 'contactsLocationsModule': {'locations': [{'zip': '69126', 'city': 'Heidelberg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Christian Nagel, MD', 'role': 'CONTACT', 'email': 'christian.nagel@thoraxklinik-heidelberg.de', 'phone': '+49 6221 396 8063'}, {'name': 'Ekkehard Grünig, Professor', 'role': 'CONTACT', 'email': 'ekkehard.gruenig@thoraxklinik-heidelberg.de', 'phone': '+49 6221 396 8053'}, {'name': 'Christian Nagel, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Center for pulmonary Hypertension, Thoraxclinic Heidelberg', 'geoPoint': {'lat': 49.40768, 'lon': 8.69079}}], 'centralContacts': [{'name': 'Ekkehard Grünig, MD, Prof.', 'role': 'CONTACT', 'email': 'ekkehard.gruenig@med.uni-heidelberg.de', 'phone': '+49 6221 396 8053'}], 'overallOfficials': [{'name': 'Christian Nagel, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Center for pulmonary hypertension, Thoraxclinic Heidelberg'}, {'name': 'Ekkehard Grünig, Professor', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Center for pulmonary hypertension, Thoraxclinic Heidelberg'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Heidelberg University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. med. Ekkehard Grünig', 'investigatorFullName': 'Prof. Dr. med. Ekkehard Gruenig', 'investigatorAffiliation': 'Heidelberg University'}}}}