Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2026-01-01 @ 3:32 PM
Study NCT ID:
NCT02594059
Status:
COMPLETED
Last Update Posted:
2021-03-17
First Post:
2015-10-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Assessment of Peripheral Endothelial Function in Idiopathic Pulmonary Fibrosis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011658', 'term': 'Pulmonary Fibrosis'}, {'id': 'D054990', 'term': 'Idiopathic Pulmonary Fibrosis'}], 'ancestors': [{'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D005355', 'term': 'Fibrosis'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 43}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-12-19', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-03', 'completionDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2021-03-16', 'studyFirstSubmitDate': '2015-10-29', 'studyFirstSubmitQcDate': '2015-10-30', 'lastUpdatePostDateStruct': {'date': '2021-03-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2015-11-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2020-07-15', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'measure of reactive hyperemia-peripheral artery tone index', 'timeFrame': 'day 1'}], 'secondaryOutcomes': [{'measure': 'endothelial function', 'timeFrame': '1, 2 and 3 years', 'description': 'measure of reactive hyperemia-peripheral artery tone index'}, {'measure': 'measure of reactive hyperemia-peripheral artery tone index', 'timeFrame': '3 years', 'description': "measure of reactive hyperemia-peripheral artery tone index at IPF exacerbation or PAHT's occurence"}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['endothelial function, idiopathic pulmonary fibrosis'], 'conditions': ['Pulmonary Fibrosis']}, 'descriptionModule': {'briefSummary': 'The aim of the study is to assess the peripheral endothelial function in adult patients with idiopathic pulmonary fibrosis (IPF) and the relationship between the peripheral endothelial function and the severity of the IPF.', 'detailedDescription': 'The primary criteria is the peripheral endothelial function that will be assessed by the measure of flow-mediated dilation (reactive hyperemia-peripheral artery tone index). The pulmonary function will be assessed by the measures of the forced expiratory volume at one second (FEV1), the forced vital capacity (FVC) and the total lung capacity (TLC) and the diffusing capacity of the lung for carbon monoxide (DLCO). The dyspnea will be assessed with the New York Heart Association (NYHA) score. The exercise capacity will be assessed by the 6-min walk test. Pulmonary arterial pressure will be recorded through cardiac echography or catheterization.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '85 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n* IPF according to ATS/ERS 2011's criteria\n* Stable IPF (no reduction of FVC or DLCO of more than 10% and 15% respectively)\n\nExclusion Criteria:\n\n* Patients with a significant disease other than IPF. A significant disease is defined as a disease which, in the opinion of the investigator, may influence the results of the trial.\n* Pregnant or nursing women.\n* Non-pulmonary fibrosis\n* treatment by pulmonary vasodilators that cannot be stopped for 24 hours for the assessment of endothelial function"}, 'identificationModule': {'nctId': 'NCT02594059', 'acronym': 'Endoth-FPI', 'briefTitle': 'Assessment of Peripheral Endothelial Function in Idiopathic Pulmonary Fibrosis', 'organization': {'class': 'OTHER', 'fullName': 'Hopital Foch'}, 'officialTitle': 'Assessment of Peripheral Endothelial Function in Idiopathic Pulmonary Fibrosis', 'orgStudyIdInfo': {'id': '2012/56'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Pulmonary idiopathic fibrosis', 'description': "Patients with pulmonary idiopathic fibrosis according to ATS/ERS 2011's criteria", 'interventionNames': ['Other: endothelial function']}], 'interventions': [{'name': 'endothelial function', 'type': 'OTHER', 'description': 'measure of reactive hyperemia-peripheral artery tone index', 'armGroupLabels': ['Pulmonary idiopathic fibrosis']}]}, 'contactsLocationsModule': {'locations': [{'zip': '75015', 'city': 'Paris', 'country': 'France', 'facility': 'Hopital Europeen Georges Pompidou, dpt of pneumology', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '92150', 'city': 'Suresnes', 'country': 'France', 'facility': 'Hopital Foch', 'geoPoint': {'lat': 48.87143, 'lon': 2.22929}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Hopital Foch', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}