Ignite Creation Date:
2025-12-25 @ 4:06 AM
Ignite Modification Date:
2026-01-15 @ 3:03 AM
Study NCT ID:
NCT02778802
Status:
UNKNOWN
Last Update Posted:
2017-01-04
First Post:
2016-05-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pulmonary Hemodynamics in Patients With Severe Emphysema Pre and Post BLVR
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D029424', 'term': 'Pulmonary Disease, Chronic Obstructive'}, {'id': 'D004646', 'term': 'Emphysema'}], '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': 'D008173', 'term': 'Lung Diseases, Obstructive'}, {'id': 'D002908', 'term': 'Chronic Disease'}, {'id': 'D020969', 'term': 'Disease Attributes'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-01', 'completionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-01-01', 'studyFirstSubmitDate': '2016-05-14', 'studyFirstSubmitQcDate': '2016-05-19', 'lastUpdatePostDateStruct': {'date': '2017-01-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-05-20', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-05', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'change in mean Pulmonary artery pressure after ELVR', 'timeFrame': '3months, 6monthes', 'description': 'Right heart cathetrization'}], 'secondaryOutcomes': [{'measure': 'Dysnea Score', 'timeFrame': '3 months,6months', 'description': 'using modified Medical Research Council (mMRC) criteria, with 0 representing dyspnea with strenuous exercise and 4 representing dyspnea with breathlessness when dressing'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Pulmonary Hypertension', 'Emphysema', 'COPD'], 'conditions': ['Pulmonary Hypertension', 'Chronic Obstructive Lung Disease']}, 'descriptionModule': {'briefSummary': 'This study is designed as a prospective study, with the primary endpoint being changes in pulmonary hemodynamic parameters after ELVR in patients with severe emphysema.\n\nSecondary endpoints will be changes in lung function parameters, exercise capacity, and QoL.', 'detailedDescription': "Chronic obstructive pulmonary disease (COPD) continues to be a leading cause of morbidity and is currently the third most common cause of mortality worldwide (1).\n\nIn most patients with severe COPD, chronic airflow limitation, lung emphysema with parenchymal destruction and the development of air bullae also occur (2-3) Pulmonary hypertension (PH) is a common consequence of COPD, although the actual overall prevalence of PH in COPD remains unclear (4). Among COPD patients who were to undergo lung-volume-reduction surgery or lung transplantation, mild PH was observed in 50.2%, moderate PH in 9.8%, and severe PH in 3.7%(5). While in most COPD patients who develop PH, pulmonary arterial pressure is only mildly or moderately elevated, (6) PH has an independent prognostic impact on survival. (6,7) The therapeutic options for COPD patients with severe emphysema are limited. Lung volume reduction surgery (LVRS) has been performed as treatment in selected cases, but the referral of patients has been severely influenced by the marked perioperative morbidity and mortality \\[8\\]. Less invasive techniques have been developed with the aim of improving patients' pulmonary function, symptoms, and quality of life (QoL) \\[9\\]. Among them, the one most commonly used is the endoscopic placement of one way endobronchial valves (EBV) \\[10-12\\]. So far patients with severe emphysema and established PH have been excluded from LVRS as well as from endoscopic lung volume reduction (ELVR) therapy.\n\nWhether bronchoscopic lung volume reduction in COPD patients with silver nitrate or histoacryl influences the severity of PH in patients with severe emphysema and PH has yet to be elucidated.\n\nThis study is designed as a prospective pilot study, with the primary endpoint being changes in pulmonary hemodynamic parameters after ELVR in patients with severe emphysema.\n\nSecondary endpoints will be changes in lung function parameters, exercise capacity, and QoL.\n\nMaterials and Methods This is Prospective descriptive study on 20 COPD Patients with predominant emphysema especially with heterogeneous and upper lobe predominance emphysema admitted in chest department at Kasr al Ainy Hospital. All patients will be on optimal medical treatment for COPD according to Global Initiative for Chronic Obstructive Lung Disease guidelines \\[13\\] All patients will be subjected to the following at base line.\n\n1. full history taking.\n2. full clinical examination.\n3. plain chest x ray.\n4. an electrocardiogram, High resolution computed tomography of the chest.\n5. Pulmonary function tests and ABG.\n6. 6-minute walk test.\n7. 2-D echocardiography at rest\n8. Right heart catheterization (RHC)\n9. Fiberoptic bronchoscopy with application of silver nitrate or histoacryl. The patients will be followed up every month by\n\n1\\. Dyspnea score (using mMRC score) 2. 6-minute walk test. 3. ECG At 3rd Month 2-D echocardiography at rest will be done At 6th Month 2-D echocardiography at rest And RHC will be done ."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '30 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'COPD Patients with predominant emphysema especially with heterogeneous and upper lobe predominance emphysema', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* COPD patients with predominant emphysema especially with heterogeneous and upper lobe predominance emphysema\n\nExclusion Criteria:\n\n1. Airflow limitation with FEV1 \\< 20%.\n2. Patients not candidate for FOB.'}, 'identificationModule': {'nctId': 'NCT02778802', 'briefTitle': 'Pulmonary Hemodynamics in Patients With Severe Emphysema Pre and Post BLVR', 'organization': {'class': 'OTHER', 'fullName': 'Cairo University'}, 'officialTitle': 'Pulmonary Hemodynamics in Patients With Severe Emphysema Pre and Post Bronchoscopic Volume Reduction by Histoacryl or Silver Nitrate (Single Center Experince )', 'orgStudyIdInfo': {'id': 'Cairo2002'}}, 'contactsLocationsModule': {'locations': [{'zip': '14211', 'city': 'Cairo', 'status': 'RECRUITING', 'country': 'Egypt', 'contacts': [{'name': 'Mostafa I Elshazly, MD', 'role': 'CONTACT', 'email': 'elshazly66@hotmail.com', 'phone': '00201001272020'}, {'name': 'Mostafa Elshazly, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Mohamed Alnady, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Karim Mahmoud, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Ahmed Amer, MSc', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Kasr Alaini School of Medicine', 'geoPoint': {'lat': 30.06263, 'lon': 31.24967}}], 'centralContacts': [{'name': 'Mostafa I Elshazly, MD', 'role': 'CONTACT', 'email': 'elshazly66@hotmail.com', 'phone': '00201001272020'}, {'name': 'Ahmed M Abd El-Fattah, MSc', 'role': 'CONTACT', 'email': 'a.house2012@yahoo.com', 'phone': '00201003655626'}], 'overallOfficials': [{'name': 'Mohamed A Elnady, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Professor of pulmonary Medicine ,Cairo University'}, {'name': 'Karim Mahmoud, MD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Lecturer of cardiology ,Cairo University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'YES', 'description': 'Publication in peer reviewed Journal'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Cairo University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of pulmonary Medicine', 'investigatorFullName': 'Mostafa Elshazly', 'investigatorAffiliation': 'Cairo University'}}}}