Ignite Creation Date:
2025-12-25 @ 12:40 AM
Ignite Modification Date:
2025-12-25 @ 10:51 PM
Study NCT ID:
NCT05368467
Status:
RECRUITING
Last Update Posted:
2025-06-26
First Post:
2022-05-05
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
National Registry and Cohort Study of Pulmonary Vascular Disease
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081029', 'term': 'Pulmonary Arterial Hypertension'}], 'ancestors': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D019468', 'term': 'Disease Management'}], 'ancestors': [{'id': 'D010346', 'term': 'Patient Care Management'}, {'id': 'D006298', 'term': 'Health Services Administration'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 1000}, 'targetDuration': '5 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2022-03-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2028-12-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-06-25', 'studyFirstSubmitDate': '2022-05-05', 'studyFirstSubmitQcDate': '2022-05-05', 'lastUpdatePostDateStruct': {'date': '2025-06-26', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-05-10', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2028-12-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'All-cause Death', 'timeFrame': '5 years'}], 'secondaryOutcomes': [{'measure': 'Number of Participants with Clinical Worsening', 'timeFrame': '5 years', 'description': 'Clinical worsening during follow-up was defined as worsening PAH or atrial septostomy or listing for lung transplantation or all-cause death. Worsening PAH required the presence of worsening PAH symptoms and a decrease in 6-minute walk distance greater than 15% from baseline and the requirement for additional PAH treatments (all three conditions had to be present).'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Pulmonary Arterial Hypertension']}, 'descriptionModule': {'briefSummary': 'This is a observational、multicenter, prospective cohort study for patients with pulmonary hypertension (PH). The purposes of this study were to evaluate the etiology、clinical characteristics、treatment modalities, and outcomes of patients with PH；also to set up registration system of PH in China, to build a database of Chinese PH, to establish a web-based international standard data acquisition system for PH and a multicenter clinical research platform. The results of the study will provide a basis for the future national health policy for prevention and treatment of PH.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with Pulmonary Hypertension from China based PH centers.', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Newly diagnosed or previously diagnosed patients with PH.\n* Documentation of mean pulmonary arterial pressure (mPAP) \\>20 mm Hg by right heart catheterization, performed at any time prior to study enrollment.\n\nExclusion Criteria:\n\n* Have not had documentation of hemodynamic criteria for PH by right heart catheterization at some time preceding study entry and following development of symptoms associated with PH.\n* Do not meet the required hemodynamic criteria for entry into the study.'}, 'identificationModule': {'nctId': 'NCT05368467', 'acronym': 'NCPVD', 'briefTitle': 'National Registry and Cohort Study of Pulmonary Vascular Disease', 'organization': {'class': 'OTHER', 'fullName': 'Nanjing First Hospital, Nanjing Medical University'}, 'officialTitle': 'National Registry and Cohort Study of Pulmonary Vascular Disease', 'orgStudyIdInfo': {'id': 'NMU20220505'}}, 'armsInterventionsModule': {'armGroups': [{'label': '1', 'description': 'All consecutive consenting patients diagnosed with PH according to specific hemodynamic criteria at participating institutions.', 'interventionNames': ['Combination Product: The clinical course and disease management']}], 'interventions': [{'name': 'The clinical course and disease management', 'type': 'COMBINATION_PRODUCT', 'description': 'The clinical course and disease management of pulmonary hypertension patients', 'armGroupLabels': ['1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Caojing Zhang', 'role': 'CONTACT'}], 'facility': 'Guangdong Provincial Peoples Hospital', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '210006', 'city': 'Nanjing', 'state': 'Jiangsu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Shaoliang Chen, MD', 'role': 'CONTACT', 'email': 'chmengx@126.com', 'phone': '+86 13605157029'}, {'name': 'Shaoliang Chen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Nanjing First Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Tianjin', 'state': 'Tianjin Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Zhenweng Yang', 'role': 'CONTACT'}], 'facility': 'General Hospital of Tianjin Medical University', 'geoPoint': {'lat': 39.14222, 'lon': 117.17667}}, {'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Hong Gu', 'role': 'CONTACT'}], 'facility': 'Beijing Anzhen Hospital of Capital Medical University', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Beijing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'zhenguo zhai', 'role': 'CONTACT'}], 'facility': 'China-japan Friendship Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'city': 'Changsha', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jiang, Li', 'role': 'CONTACT'}], 'facility': 'Xiangya Second Hospital, Central South University', 'geoPoint': {'lat': 28.19874, 'lon': 112.97087}}, {'city': 'Chendu', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yucheng, Chen', 'role': 'CONTACT'}], 'facility': 'West China Hospital, Sichuan University', 'geoPoint': {'lat': 30.92504, 'lon': 121.03163}}, {'city': 'Nanjing', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Jiaxin Ye', 'role': 'CONTACT'}], 'facility': 'Nanjing Drum Tower Hospital', 'geoPoint': {'lat': 32.06167, 'lon': 118.77778}}, {'city': 'Shenyang', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Qiguang Wang', 'role': 'CONTACT'}], 'facility': 'General Hospital of Northen Theater of Command', 'geoPoint': {'lat': 41.79222, 'lon': 123.43278}}, {'city': 'Wuhan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaomei Guo', 'role': 'CONTACT'}], 'facility': 'Tongji Hospital, Huazhong University of Science and Technology', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': 'Wuhan', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Gangcheng Zhang', 'role': 'CONTACT'}], 'facility': 'Zhongnan Hospital of Wuhan University', 'geoPoint': {'lat': 30.58333, 'lon': 114.26667}}, {'city': "Xi'an", 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Fenling Fan', 'role': 'CONTACT'}], 'facility': "First Affiliated Hospital of Xi'An Jiaotong University", 'geoPoint': {'lat': 34.25833, 'lon': 108.92861}}, {'city': 'Zhengzhou', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Heping Gu', 'role': 'CONTACT'}], 'facility': 'First Hospital of Zhengzhou University', 'geoPoint': {'lat': 34.75778, 'lon': 113.64861}}], 'centralContacts': [{'name': 'Shao-Liang Chen, MD, PhD', 'role': 'CONTACT', 'email': 'chmengx@126.com', 'phone': '+86-25-52271351'}, {'name': 'Jing Kan, MPH', 'role': 'CONTACT', 'email': 'kanjingok@126.com', 'phone': '+86-25-52271398'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Nanjing First Hospital, Nanjing Medical University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Vice President of Nanjing First Hospital, Director of Cardiovascular Department', 'investigatorFullName': 'Shaoliang Chen, MD', 'investigatorAffiliation': 'Nanjing First Hospital, Nanjing Medical University'}}}}