Ignite Creation Date:
2025-12-25 @ 12:28 AM
Ignite Modification Date:
2025-12-25 @ 10:35 PM
Study NCT ID:
NCT04654767
Status:
RECRUITING
Last Update Posted:
2024-04-16
First Post:
2020-11-25
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Inflammatory Profiling in Chronic Lung Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}], 'ancestors': [{'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood samples, explant lung tissue'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 60}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2021-12-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2025-06-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-04-15', 'studyFirstSubmitDate': '2020-11-25', 'studyFirstSubmitQcDate': '2020-12-03', 'lastUpdatePostDateStruct': {'date': '2024-04-16', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Analysis of inflammatory cell profile', 'timeFrame': 'within 36 months', 'description': 'The number of leukocytes (CD45+ cells) and derivatives (percentage lymphocytes, monocytes and neutrophils) will be measured by flow cytometry in explanted lung tissue and blood of patients with CLD-PH and controls.\n\nValues will be reported as %CD45+ and %total cells.'}], 'secondaryOutcomes': [{'measure': 'Degree of pulmonary vascular disease', 'timeFrame': 'within 36 months', 'description': 'Pulmonary vascular disease will be assessed by associated clinical data (mPAP (mmHg), PVR (WU))\n\n1. CLD without PH (mPAP \\<21 mmHg, or mPAP 21-24 mmHg with pulmonary vascular resistance (PVR) \\<3 Wood Units (WU)).\n2. CLD with PH (mPAP 21-24 mmHg with PVR ≥3 WU, or mPAP 25-34 mmHg) (CLD-PH).\n3. CLD with severe PH (mPAP ≥35 mmHg, or mPAP ≥25 mmHg with low cardiac index (\\<2.0 L·min-1·m-2)) (CLD-severe PH).'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Vascular Diseases', 'Lung Diseases', 'Respiratory Tract Diseases'], 'conditions': ['Pulmonary Hypertension']}, 'descriptionModule': {'briefSummary': 'The aim of this study is to investigate the underlying inflammatory profile in patients with chronic lung disease and determine the association pulmonary hypertension.', 'detailedDescription': 'Chronic lung diseases (CLD), such as chronic obstructive pulmonary disease (COPD) and idiopathic pulmonary fibrosis (IPF) are often complicated by the presence of pulmonary hypertension (PH), where even a mild elevation of blood pressure in the pulmonary arteries is associated with an even poorer prognosis. In this study, we will investigate whether similarities exist in the inflammatory profile that could potentially underlie all forms of pulmonary hypertension. Inflammatory data will be generated using flow cytometry, expression profiling and histological analysis and compared to the associated clinical data.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Subjects undergoing lung transplantation at the Medical University of Vienna', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients undergoing lung transplant with COPD or IPF, with associated PH\n* Signed informed consent\n\nExclusion Criteria:\n\n* patients without written informed consent\n* Signs of any infection such as pneumonia, pulmonary tuberculosis or infections with pleural effusions.'}, 'identificationModule': {'nctId': 'NCT04654767', 'briefTitle': 'Inflammatory Profiling in Chronic Lung Disease', 'organization': {'class': 'OTHER', 'fullName': 'Ludwig Boltzmann Institute for Lung Vascular Research'}, 'officialTitle': 'Inflammatory Profiling in Chronic Lung Disease', 'orgStudyIdInfo': {'id': 'LBILVR-KLI 884-B'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'COPD-PH group', 'description': 'Patients with confirmed COPD and pulmonary hypertension', 'interventionNames': ['Other: Tissue sampling']}, {'label': 'IPF-PH', 'description': 'Patients with confirmed pulmonary fibrosis and pulmonary hypertension', 'interventionNames': ['Other: Tissue sampling']}, {'label': 'Control group', 'description': 'Control group without diagnosed COPD, IPF, or pulmonary hypertension', 'interventionNames': ['Other: Tissue sampling']}], 'interventions': [{'name': 'Tissue sampling', 'type': 'OTHER', 'description': 'Blood collection via venipuncture into citrate- or ethylenediaminetetraacetic (EDTA)-containing vacutainer tubes and into serum tubes. Explant lung tissue obtained from patients that underwent lung transplantation.\n\nNon-transplanted donor lungs that had been harvested for transplantation, but not implanted because of size-reduction serve as controls.', 'armGroupLabels': ['COPD-PH group', 'Control group', 'IPF-PH']}]}, 'contactsLocationsModule': {'locations': [{'zip': '1090', 'city': 'Vienna', 'status': 'RECRUITING', 'country': 'Austria', 'contacts': [{'name': 'Walter Klepetko, Prof', 'role': 'CONTACT', 'email': 'walter.klepetko@meduniwien.ac.at', 'phone': '0043140400', 'phoneExt': '56440'}, {'name': 'Elisabeth Gschwandtner, Dr', 'role': 'CONTACT', 'email': 'elisabeth.gschwandtner@meduniwien.ac.at', 'phone': '0043140400', 'phoneExt': '56440'}], 'facility': 'Division of Thoracic Surgery, Department of Surgery, Medical University of Vienna', 'geoPoint': {'lat': 48.20849, 'lon': 16.37208}}], 'centralContacts': [{'name': 'Leigh Marsh', 'role': 'CONTACT', 'email': 'leigh.marsh@lvr.lbg.ac.at', 'phone': '+4331638572911'}], 'overallOfficials': [{'name': 'Leigh Marsh', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Ludwig Boltzmann Institute for Lung Vascular Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Ludwig Boltzmann Institute for Lung Vascular Research', 'class': 'OTHER'}, 'collaborators': [{'name': 'Medical University of Graz', 'class': 'OTHER'}, {'name': 'Medical University of Vienna', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}