Ignite Creation Date:
2025-12-24 @ 2:44 PM
Ignite Modification Date:
2025-12-25 @ 2:02 PM
Study NCT ID:
NCT06926959
Status:
RECRUITING
Last Update Posted:
2025-04-15
First Post:
2025-03-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Tricuspid RegurgitAtion rIsk modeL Study (TRAIL Study)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D014262', 'term': 'Tricuspid Valve Insufficiency'}], 'ancestors': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}, {'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 3000}, 'targetDuration': '15 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-06-15', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2030-06-15', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-11', 'studyFirstSubmitDate': '2025-03-24', 'studyFirstSubmitQcDate': '2025-04-11', 'lastUpdatePostDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-06-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'all-cause mortality', 'timeFrame': 'Through study completion, an average of 5 years', 'description': 'Death due to any cause after enrollment'}], 'secondaryOutcomes': [{'measure': 'Cardiovascular death', 'timeFrame': 'Through study completion, an average of 5 years', 'description': 'Death caused by cardiac causes'}, {'measure': 'Heart Failure Hospitalization', 'timeFrame': 'Through study completion, an average of 5 years', 'description': 'Hospitalization with the primary reason for admission as acute decompensated HF and administration of intravenous or mechanical heart failure therapies.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Tricuspid Regurgitation', 'all-cause mortality', 'risk factor', 'prediction model'], 'conditions': ['Tricuspid Regurgitation']}, 'descriptionModule': {'briefSummary': 'This study is a multicenter cohort study including patients diagnosed with tricuspid regurgitation during hospitalization. The primary outcome of the study is all-cause death, and the secondary outcome is cardiovascular events. The prognostic risk factors of patients with tricuspid regurgitation are evaluated, and the prognostic models are constructed through the follow-up observation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Adult patients diagnosed with tricuspid regurgitation (TR) during hospitalization were enrolled.', 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged over 18 yrs.\n* Patients diagnosed with tricuspid regurgitation during hospitalization.\n\nExclusion Criteria:\n\n* Patients unable to provide informed consent.'}, 'identificationModule': {'nctId': 'NCT06926959', 'briefTitle': 'Tricuspid RegurgitAtion rIsk modeL Study (TRAIL Study)', 'organization': {'class': 'OTHER', 'fullName': 'Sun Yat-sen University'}, 'officialTitle': 'Tricuspid RegurgitAtion rIsk modeL Study (TRAIL Study)', 'orgStudyIdInfo': {'id': 'TRAIL study'}}, 'contactsLocationsModule': {'locations': [{'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Xiaodong Zhuang', 'role': 'CONTACT', 'email': 'zhuangxd3@mail.sysu.edu.cn', 'phone': '+8613760755035'}], 'facility': 'The First Affiliated Hospital of Sun Yat-sen Univerity', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '510000', 'city': 'Guangzhou', 'state': 'Guangdong', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'Third Affiliated Hospital, Sun Yat-Sun University,', 'geoPoint': {'lat': 23.11667, 'lon': 113.25}}, {'zip': '522000', 'city': 'Jieyang', 'state': 'Guangdong', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': "Jieyang People's Hospital", 'geoPoint': {'lat': 23.5418, 'lon': 116.36581}}, {'zip': '515041', 'city': 'Shantou', 'state': 'Guangdong', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'Second Affiliated Hospital of Shantou University Medical College', 'geoPoint': {'lat': 23.35489, 'lon': 116.67876}}, {'zip': '518000', 'city': 'Shenzhen', 'state': 'Guangdong', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'Eighth Affiliated Hospital, Sun Yat-Sen University', 'geoPoint': {'lat': 22.54554, 'lon': 114.0683}}, {'zip': '524001', 'city': 'Zhanjiang', 'state': 'Guangdong', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': 'Affiliated Hospital of Guangdong Medical University', 'geoPoint': {'lat': 21.23391, 'lon': 110.38749}}, {'zip': '528400', 'city': 'Zhongshan', 'state': 'Guangdong', 'status': 'ACTIVE_NOT_RECRUITING', 'country': 'China', 'facility': "Zhongshan People's Hospital", 'geoPoint': {'lat': 22.52306, 'lon': 113.37912}}], 'centralContacts': [{'name': 'Xiaodong Zhuang', 'role': 'CONTACT', 'email': 'zhuangxd3@mail.sysu.edu.cn', 'phone': '+8613760755035'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Sun Yat-sen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'First Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, {'name': 'Third Affiliated Hospital, Sun Yat-Sen University', 'class': 'OTHER'}, {'name': 'Affiliated Hospital of Guangdong Medical University', 'class': 'OTHER'}, {'name': 'Second Affiliated Hospital of Shantou University Medical College', 'class': 'OTHER'}, {'name': 'Eighth Affiliated Hospital, Sun Yat-sen University', 'class': 'OTHER'}, {'name': "Zhongshan People's Hospital, Guangdong, China", 'class': 'OTHER'}, {'name': "Jieyang People's Hospital", 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Xiao-dong Zhuang', 'investigatorAffiliation': 'Sun Yat-sen University'}}}}