Ignite Creation Date:
2025-12-25 @ 3:01 AM
Ignite Modification Date:
2025-12-30 @ 6:13 PM
Study NCT ID:
NCT07082933
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-07-24
First Post:
2025-07-16
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Long-term Survival and Influencing Factors of Patients With Pulmonary Arterial Hypertension and Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D000081029', 'term': 'Pulmonary Arterial Hypertension'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D006976', 'term': 'Hypertension, Pulmonary'}, {'id': 'D008171', 'term': 'Lung Diseases'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'RETROSPECTIVE', 'observationalModel': 'OTHER'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 5000}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-08-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2027-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-07-16', 'studyFirstSubmitDate': '2025-07-16', 'studyFirstSubmitQcDate': '2025-07-16', 'lastUpdatePostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-07-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2027-08-01', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Brain natriuretic peptide', 'timeFrame': 'baseline'}, {'measure': 'blood glucose', 'timeFrame': 'baseline'}], 'primaryOutcomes': [{'measure': 'Overall Survival', 'timeFrame': '10 years', 'description': 'Time from diagnosis of pulmonary hypertension to death'}], 'secondaryOutcomes': [{'measure': 'Pulmonary Artery Pressure(PAP)', 'timeFrame': 'baseline'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Pulmonary arterial hypertension', 'Diabetes', 'Mortality'], 'conditions': ['Pulmonary Arterial Hypertension (PAH)']}, 'descriptionModule': {'briefSummary': 'This is a multicenter retrospective cohort study on pulmonary arterial hypertension. It is expected to collect data from no less than 5,000 patients to compare the long-term overall survival of patients with and without diabetes, and analysis the risk factors of the overall survival .'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients diagnosed with pulmonary hypertension', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Individuals aged 18 to 80 years with full capacity for civil conduct.\n* Patients diagnosed with pulmonary hypertension by community-level and/or higher-level medical institutions.\n\nExclusion Criteria:\n\n* Patients with malignant tumors.\n* Other physical conditions judged by the researchers as making the patients ineligible to participate in the clinical study.'}, 'identificationModule': {'nctId': 'NCT07082933', 'briefTitle': 'Long-term Survival and Influencing Factors of Patients With Pulmonary Arterial Hypertension and Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Xijing Hospital'}, 'officialTitle': 'Long-term Survival and Influencing Factors of Patients With Pulmonary Arterial Hypertension and diabetes-a Multicenter Retrospective Cohort Study', 'orgStudyIdInfo': {'id': 'KY-20252240'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'pulmonary arterial hypertension combined with diabetes', 'description': 'patients with pulmonary arterial hypertension and diabetes', 'interventionNames': ['Other: Standard medical treatment']}, {'label': 'pulmonary arterial hypertension without comorbid diabetes', 'description': 'pulmonary arterial hypertension without comorbid diabetes', 'interventionNames': ['Other: Standard medical treatment']}], 'interventions': [{'name': 'Standard medical treatment', 'type': 'OTHER', 'description': 'Standard medical treatment', 'armGroupLabels': ['pulmonary arterial hypertension combined with diabetes', 'pulmonary arterial hypertension without comorbid diabetes']}]}, 'contactsLocationsModule': {'centralContacts': [{'name': 'Yue Zhang, Doctor', 'role': 'CONTACT', 'email': 'zhangy718@foxmail.com', 'phone': '0086+13022957751'}], 'overallOfficials': [{'name': 'Yue Zhang, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Department of Health Management, Xijing Hospital, Air Force Medical University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Xijing Hospital', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}