Ignite Creation Date:
2025-12-25 @ 1:45 AM
Ignite Modification Date:
2026-02-22 @ 7:22 PM
Study NCT ID:
NCT03667794
Status:
COMPLETED
Last Update Posted:
2018-09-14
First Post:
2018-09-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Evaluation of Novel Lung Function Parameters in Patients With Pulmonary Hypertension (PH)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}], 'ancestors': [{'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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010993', 'term': 'Plethysmography, Whole Body'}], 'ancestors': [{'id': 'D010991', 'term': 'Plethysmography'}, {'id': 'D003935', 'term': 'Diagnostic Techniques, Cardiovascular'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D012129', 'term': 'Respiratory Function Tests'}, {'id': 'D003948', 'term': 'Diagnostic Techniques, Respiratory System'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'CROSS_SECTIONAL', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 75}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-07-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-12', 'studyFirstSubmitDate': '2018-09-06', 'studyFirstSubmitQcDate': '2018-09-10', 'lastUpdatePostDateStruct': {'date': '2018-09-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-09-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-07-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'LCI', 'timeFrame': '30 minutes', 'description': 'between-group difference in lung clearance index (LCI)'}, {'measure': 'D5-20', 'timeFrame': '30 minutes', 'description': 'between-group difference in frequency dependence of resistance (D5-20)'}], 'secondaryOutcomes': [{'measure': 'Discrimination small airway resistance', 'timeFrame': '30 minutes', 'description': 'Evaluation of discriminative capability of impulse oscillometry'}, {'measure': 'Discrimination ventilation heterogeneity', 'timeFrame': '30 minutes', 'description': 'Evaluation of discriminative capability of multiple breath washout'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Hypertension']}, 'descriptionModule': {'briefSummary': 'Little is known about affection of small airways in patients with pulmonary hypertension as well as the ideal diagnostic approach. The investigators therefore aimed to evaluate novel or not widely used lung function tests for the evaluation of airway function in patients with PH.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '99 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'PH group: known or first diagnosis of PH\n\nHealthy controls: normal lung function testing including whole-body plethysmography and transfer factor, no previously diagnosed pulmonary disease as well as no respiratory symptoms.\n\nNon-healthy controls: stable pulmonary comorbidities including COPD, sarcoidosis, asthma, or fibrosis as well as non-pulmonary comorbidities.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* known or first diagnosis of PH\n\nExclusion Criteria:\n\n* inability to perform lung function testing\n* unable or unwilling to participate'}, 'identificationModule': {'nctId': 'NCT03667794', 'briefTitle': 'Evaluation of Novel Lung Function Parameters in Patients With Pulmonary Hypertension (PH)', 'organization': {'class': 'OTHER', 'fullName': 'Universitätsmedizin Mannheim'}, 'officialTitle': 'Evaluation of Novel Lung Function Parameters in Patients With Pulmonary Hypertension (PH)', 'orgStudyIdInfo': {'id': 'MBW-PH'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'PH patients', 'description': 'Patients with known or first diagnosis of PH', 'interventionNames': ['Diagnostic Test: body plethysmography', 'Diagnostic Test: impulse oscillometry', 'Diagnostic Test: multiple breath washout']}, {'label': 'healthy controls', 'description': 'Healthy controls had normal lung function testing including whole-body plethysmography and transfer factor, no previously diagnosed pulmonary disease as well as no respiratory symptoms.', 'interventionNames': ['Diagnostic Test: body plethysmography', 'Diagnostic Test: impulse oscillometry', 'Diagnostic Test: multiple breath washout']}, {'label': 'non-healthy controls', 'description': 'Non-healthy controls were allowed to have stable pulmonary comorbidities including chronic obstructive pulmonary disease (COPD), sarcoidosis, asthma, or fibrosis as well as non-pulmonary comorbidities.', 'interventionNames': ['Diagnostic Test: body plethysmography', 'Diagnostic Test: impulse oscillometry', 'Diagnostic Test: multiple breath washout']}], 'interventions': [{'name': 'body plethysmography', 'type': 'DIAGNOSTIC_TEST', 'description': 'measurement of conventional lung function parameters', 'armGroupLabels': ['PH patients', 'healthy controls', 'non-healthy controls']}, {'name': 'impulse oscillometry', 'type': 'DIAGNOSTIC_TEST', 'description': 'measurement of central and peripheral airway resistance', 'armGroupLabels': ['PH patients', 'healthy controls', 'non-healthy controls']}, {'name': 'multiple breath washout', 'type': 'DIAGNOSTIC_TEST', 'description': 'measurement of ventilation heterogeneity', 'armGroupLabels': ['PH patients', 'healthy controls', 'non-healthy controls']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Frederik Trinkmann, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitätsmedizin Mannheim'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitätsmedizin Mannheim', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Dr. Frederik Trinkmann', 'investigatorAffiliation': 'Universitätsmedizin Mannheim'}}}}