Nctid:
NCT06613321
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-10-04"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D000006976", "term"=>"Hypertension, Pulmonary"}, {"id"=>"D000006973", "term"=>"Hypertension"}], "ancestors"=>[{"id"=>"D000014652", "term"=>"Vascular Diseases"}, {"id"=>"D000002318", "term"=>"Cardiovascular Diseases"}, {"id"=>"D000008171", "term"=>"Lung Diseases"}, {"id"=>"D000012140", "term"=>"Respiratory Tract Diseases"}], "browseLeaves"=>[{"id"=>"M10024", "name"=>"Hypertension", "asFound"=>"Hypertension", "relevance"=>"HIGH"}, {"id"=>"M11168", "name"=>"Lung Diseases", "relevance"=>"LOW"}, {"id"=>"M11170", "name"=>"Lung Diseases, Obstructive", "relevance"=>"LOW"}, {"id"=>"M23449", "name"=>"Pulmonary Disease, Chronic Obstructive", "relevance"=>"LOW"}, {"id"=>"M10027", "name"=>"Hypertension, Pulmonary", "asFound"=>"Hypertension, Pulmonary", "relevance"=>"HIGH"}, {"id"=>"M7292", "name"=>"Dilatation, Pathologic", "relevance"=>"LOW"}, {"id"=>"M17400", "name"=>"Vascular Diseases", "relevance"=>"LOW"}, {"id"=>"M14977", "name"=>"Respiratory Tract Diseases", "relevance"=>"LOW"}, {"id"=>"T1303", "name"=>"Chronic Graft Versus Host Disease", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Heart and Blood Diseases", "abbrev"=>"BC14"}, {"name"=>"All Conditions", "abbrev"=>"All"}, {"name"=>"Respiratory Tract (Lung and Bronchial) Diseases", "abbrev"=>"BC08"}, {"name"=>"Symptoms and General Pathology", "abbrev"=>"BC23"}, {"name"=>"Rare Diseases", "abbrev"=>"Rare"}]}, "interventionBrowseModule"=>{"meshes"=>[{"id"=>"D000014665", "term"=>"Vasodilator Agents"}], "browseLeaves"=>[{"id"=>"M17412", "name"=>"Vasodilator Agents", "asFound"=>"Blood clot", "relevance"=>"HIGH"}], "browseBranches"=>[{"name"=>"Vasodilator Agents", "abbrev"=>"VaDiAg"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}]}}, "protocolSection"=>{"designModule"=>{"studyType"=>"OBSERVATIONAL", "designInfo"=>{"timePerspective"=>"RETROSPECTIVE", "observationalModel"=>"CASE_CONTROL"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>47}, "patientRegistry"=>false}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2023-08-01", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-09", "completionDateStruct"=>{"date"=>"2024-03-25", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-09-23", "studyFirstSubmitDate"=>"2023-10-09", "studyFirstSubmitQcDate"=>"2024-09-23", "lastUpdatePostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-09-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2024-03-25", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Response to treatment", "timeFrame"=>"3 - 12 months", "description"=>"Response to treatment is defined as an improvement of at least 30 meters in the 6-minute walk test or one NYHA functional class at the first re-evaluation performed at least 3 months after the initiation of vasodilator therapy. These criteria will be compared according to the severity of chest distension."}]}, "oversightModule"=>{"isUsExport"=>false, "oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"keywords"=>["copd", "pulmonary distension", "lung distension disorders", "pulmonary hypertension", "vasodilator therapy"], "conditions"=>["Copd", "Hypertension, Pulmonary", "Hyperdistention"]}, "descriptionModule"=>{"briefSummary"=>"The goal of this retrospective observational study is to evaluate if lung distension disorders can be a predictive factor of bad response to vasodilator therapy in patients with pulmonary hypertension (PH) associated with chronic obstructive pulmonary disease (COPD).\n\nThe study will include all patients from the hospital, followed for pulmonary hypertension associated with COPD under vasodilator therapy between 2015 and 2021.", "detailedDescription"=>"The goal of this retrospective observational study is to evaluate if lung distension disorders can be a predictive factor of bad response to vasodilator therapy in patients with pulmonary hypertension (PH) associated with chronic obstructive pulmonary disease (COPD).\n\nThe study will include all patients from the hospital, followed for PH associated with COPD under vasodilator therapy between 2015 and 2021.\n\nIt will evaluate patients' lung hyperinflation according to the RV/TLC ratio and their response to treatment."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"18 years", "samplingMethod"=>"NON_PROBABILITY_SAMPLE", "studyPopulation"=>"All patients with pulmonary hypertension associated with COPD undergoing vasodilator therapy at Nancy University Hospital (France) from January 1, 2015 to April 1, 2023.", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n* Patients with COPD regardless of severity defined as a FEV1/FVC ratio less than 0.70 and the presence of a risk factor (smoke exposure with at least a 10 pack-year history, or professional exposition) diagnosed with PH according to ESC/ERS 2022 classification and in whom vasodilator therapy has been initiated\n\nExclusion Criteria:\n\n* other known concomitant lung disease (interstitial lung disease, cystic lung disease, mucoviscidosis...)\n* thoracic pathology such as kyphoscoliosis\n* pleural effusion (unless part of pulmonary veno-occlusive disease)\n* a large tumor lung mass\n* EFR missing or uninterpretable because difficult to perform\n* initiation of calcium channel blockers\n* surgical treatment in chronic thrombo-embolic pulmonary hypertension\n* no follow-up evaluation (lost to follow-up or died before reassessment)"}, "identificationModule"=>{"nctId"=>"NCT06613321", "briefTitle"=>"Lung Hyperinflation and Response to Pulmonary Vasodilator Therapy", "organization"=>{"class"=>"OTHER", "fullName"=>"Central Hospital, Nancy, France"}, "officialTitle"=>"Impact of Lung Hyperinflation on the Response to Pulmonary Vasodilator Therapy in Patients with Pulmonary Hypertension (PH) Associated with Chronic Obstructive Pulmonary Disease (COPD).", "orgStudyIdInfo"=>{"id"=>"2023PI014"}}, "armsInterventionsModule"=>{"armGroups"=>[{"label"=>"Patients with increased lung distension", "description"=>"Defined by a residual volume over total lung capacity ratio (RV/TLC ratio) above the median value of all included patients.", "interventionNames"=>["Diagnostic Test: Respiratory function tests before introduction of vasodilator therapy", "Diagnostic Test: 3 month follow up evaluation of response to treatment."]}, {"label"=>"Patients without increased distension disorder", "description"=>"Defined by a residual volume over total lung capacity ratio (RV/TLC ratio) below the median value of all included patients.", "interventionNames"=>["Diagnostic Test: Respiratory function tests before introduction of vasodilator therapy", "Diagnostic Test: 3 month follow up evaluation of response to treatment."]}], "interventions"=>[{"name"=>"Respiratory function tests before introduction of vasodilator therapy", "type"=>"DIAGNOSTIC_TEST", "description"=>"Respiratory function tests before introduction of vasodilator therapy with evaluation of the RV/TLC ratio.", "armGroupLabels"=>["Patients with increased lung distension", "Patients without increased distension disorder"]}, {"name"=>"3 month follow up evaluation of response to treatment.", "type"=>"DIAGNOSTIC_TEST", "description"=>"Follow up of patients at least 3 months after introduction of vasodilator therapy to determine response to treatment or absence of response.", "armGroupLabels"=>["Patients with increased lung distension", "Patients without increased distension disorder"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"54500", "city"=>"Vandoeuvre-les-nancy", "country"=>"France", "facility"=>"CHU Nancy", "geoPoint"=>{"lat"=>48.65, "lon"=>6.18333}}], "overallOfficials"=>[{"name"=>"Ari Chaouat, MD PhD", "role"=>"PRINCIPAL_INVESTIGATOR", "affiliation"=>"Université de Lorraine, Département de Pneumologie, CHRU NANCY"}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Central Hospital, Nancy, France", "class"=>"OTHER"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
