Ignite Creation Date:
2025-12-24 @ 10:41 PM
Ignite Modification Date:
2026-01-22 @ 2:32 PM
Study NCT ID:
NCT05458635
Status:
COMPLETED
Last Update Posted:
2022-07-14
First Post:
2022-07-04
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Predictors of Pulmonary Hypertension in Patients With Hypersensitivity Pneumonitis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D000542', 'term': 'Alveolitis, Extrinsic Allergic'}], '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'}, {'id': 'D017563', 'term': 'Lung Diseases, Interstitial'}, {'id': 'D012130', 'term': 'Respiratory Hypersensitivity'}, {'id': 'D006969', 'term': 'Hypersensitivity, Immediate'}, {'id': 'D006967', 'term': 'Hypersensitivity'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'DIAGNOSTIC', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-08-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-07', 'completionDateStruct': {'date': '2021-03-15', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-07-12', 'studyFirstSubmitDate': '2022-07-04', 'studyFirstSubmitQcDate': '2022-07-12', 'lastUpdatePostDateStruct': {'date': '2022-07-14', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-07-14', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-10-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Percentage of pulmonary hypertension in patients with HP', 'timeFrame': '6 months', 'description': 'primary oucome'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Hypertension', 'Hypersensitivity Pneumonitis']}, 'referencesModule': {'references': [{'pmid': '36759788', 'type': 'DERIVED', 'citation': 'Elnady MA, Elkorashy R, Nabil A, Ibrahim EK. Predictors of pulmonary hypertension in patients with hypersensitivity pneumonitis. BMC Pulm Med. 2023 Feb 9;23(1):61. doi: 10.1186/s12890-023-02347-1.'}]}, 'descriptionModule': {'briefSummary': 'Hypersensitivity pneumonitis (HP) is a complex immune mediated disorders caused by repeated inhalation of and sensitization to wide range of antigens including organic particles and chemical compounds, leading to exaggerated immuneresponse. Hypersenstivity pneumonitis is a common form of diffuse parenchymal lung diseases in Egypt .Pulmonary hypertension has been found as a complication of a number of diseases affecting the lung interstitium, including hypersensitivity pneumonitis, with subsequent affection of the life expectancy Rationale of the study: to find predictors for the development of pulmonary hypertension in patients with hypersensitivity pneumonitis', 'detailedDescription': 'Cross sectional study included 60 patients with established diagnosis of HP , work up includes history of exposure, clinical examination, HRCT chest, ABGs,6MWD, desaturation degree , spirometry, echocardiography and right heart catheter in patients with high echo probability of PH.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '29 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* All patients with confirmed diagnosis of Hypersensitivity pneumonitis\n\nExclusion Criteria:\n\n* Other interstitial lung diseases'}, 'identificationModule': {'nctId': 'NCT05458635', 'briefTitle': 'Predictors of Pulmonary Hypertension in Patients With Hypersensitivity Pneumonitis', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Predictors of Pulmonary Hypertension in Patients With Hypersensitivity Pneumonitis', 'orgStudyIdInfo': {'id': 'MS-131-2019'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'HP without Pulmonary hypertion', 'description': 'HRCT chest , pulmonary functions and echocardiography'}, {'type': 'ACTIVE_COMPARATOR', 'label': 'HP with Pulmonary hypertion', 'description': 'HRCT chest , pulmonary functions ,echocardiography and RT heart catheter in high echocardiographic probability of PH', 'interventionNames': ['Procedure: Right heart catheter']}], 'interventions': [{'name': 'Right heart catheter', 'type': 'PROCEDURE', 'description': 'Right heart catheterization was performed for 4 cases with high probability of pulmonary hypertension using multi-lumen swan ganz catheter.', 'armGroupLabels': ['HP with Pulmonary hypertion']}]}, 'contactsLocationsModule': {'locations': [{'zip': '11562', 'city': 'Cairo', 'country': 'Egypt', 'facility': 'Kasr alainy school of medicine', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor of pulmonology', 'investigatorFullName': 'Eman Kamal Ibrahim Hassan', 'investigatorAffiliation': 'Cairo University'}}}}