Ignite Creation Date:
2025-12-26 @ 1:18 PM
Ignite Modification Date:
2026-03-08 @ 3:15 AM
Study NCT ID:
NCT03484806
Status:
COMPLETED
Last Update Posted:
2022-04-13
First Post:
2018-03-26
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The China Valvular Heart Disease Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006349', 'term': 'Heart Valve Diseases'}], 'ancestors': [{'id': 'D006331', 'term': 'Heart Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 13917}, 'targetDuration': '2 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2018-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-04', 'completionDateStruct': {'date': '2020-10-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2022-04-06', 'studyFirstSubmitDate': '2018-03-26', 'studyFirstSubmitQcDate': '2018-03-26', 'lastUpdatePostDateStruct': {'date': '2022-04-13', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-04-02', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-09-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'all-cause mortality', 'timeFrame': '2years'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Valvular Heart Disease']}, 'referencesModule': {'references': [{'pmid': '40097371', 'type': 'DERIVED', 'citation': 'Hu X, Ye Y, Li Z, Liu Q, Zhao Z, Zhou Z, Wang W, Yu Z, Zhang H, Duan Z, Wang B, Zhang B, Lv J, Guo S, Zhao Y, Gao R, Xu H, Wu Y; China-VHD Study Collaborators. Primary regional disparities in clinical characteristics, treatments, and outcomes of a typically designed study of valvular heart disease at 46 tertiary hospitals in China: Insights from the China-VHD Study. Chin Med J (Engl). 2025 Apr 20;138(8):937-946. doi: 10.1097/CM9.0000000000003570. Epub 2025 Mar 18.'}, {'pmid': '35111828', 'type': 'DERIVED', 'citation': 'Zhao Q, Zhang B, Ye Y, Li Z, Liu Q, Zhao R, Zhao Z, Wang W, Yu Z, Zhang H, Duan Z, Wang B, Lv J, Guo S, Zhao Y, Gao R, Xu H, Wu Y. Prognostic Impact of Left Ventricular Ejection Fraction in Patients With Moderate Aortic Regurgitation: Potential Implications for Treatment Decision-Making. Front Cardiovasc Med. 2022 Jan 17;8:800961. doi: 10.3389/fcvm.2021.800961. eCollection 2021.'}]}, 'descriptionModule': {'briefSummary': 'This is a observational、multicenter, prospective cohort study for adults with significant VHD. The purposes of this study were to evaluate the etiology、clinical characteristics、treatment modalities, and outcomes of patients with VHD；also to set up registration system of adult VHD in China, to build a database of Chinese adult VHD, to establish a web-based international standard data acquisition system for VHD 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 adult VHD.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'patients over 60 years old with significant VHD', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* patients over 60 years old meet one of the following conditions.\n\n 1. moderate or above valvular heart disease as defined by echocardiography: （1）aortic stenosis, moderate or above, or valve area ≤1.5cm2, or maximal jet velocity ≥3.0m/sec, or mean pressure gradient ≥20mmHg, （2）aortic regurgitation, moderate or above, or jet width ≥25% of left ventricular outflow tract, or regurgitant volume ≥30ml/beat, or regurgitant fraction ≥30%, （3）mitral stenosis, moderate or above, or valve area ≤1.5cm2, （4）mitral regurgitation, moderate or above, or effective regurgitant orifice ≥0.2cm2, or regurgitant volume ≥30ml/beat, or regurgitant fraction ≥30%, （5）tricuspid stenosis, moderate or above, or valve area ≤1.0cm2, （6）tricuspid regurgitation, moderate or above, or central jet area ≥5.0cm2, （7）pulmonic stenosis, moderate or above, or maximal jet velocity \\>4m/sec, （8）pulmonic regurgitation, moderate or above,\n 2. or patients who had undergone any operation on a cardiac valve (percutaneous balloon commissurotomy, valve repair, valve replacement, transcatheter aortic valve implantation),\n 3. or diagnosis of endocarditis as assessed by Duke criteria.\n\nExclusion Criteria:\n\n* Patients cannot be followed up for any reasons. Patients have been enrolled in this study.'}, 'identificationModule': {'nctId': 'NCT03484806', 'acronym': 'China-VHD', 'briefTitle': 'The China Valvular Heart Disease Study', 'organization': {'class': 'OTHER_GOV', 'fullName': 'China National Center for Cardiovascular Diseases'}, 'officialTitle': 'China Registry and Cohort Study of Valvular Heart Disease in Adults', 'orgStudyIdInfo': {'id': '2017-I2M-3-002'}}, 'contactsLocationsModule': {'locations': [{'zip': '100037', 'city': 'Beijing', 'state': 'Beijing Municipality', 'country': 'China', 'facility': 'Fuwai Hospital, National Center for Cardiovascular Diseases，Chinese Academy of Medical Sciences', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'overallOfficials': [{'name': 'yongjian wu, doctor', 'role': 'STUDY_CHAIR', 'affiliation': 'Fuwai Hospital, National Center for Cardiovascular Diseases，Chinese Academy of Medical Sciences'}, {'name': 'haiyan xu, doctor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Fuwai Hospital, National Center for Cardiovascular Diseases，Chinese Academy of Medical Sciences'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'China National Center for Cardiovascular Diseases', 'class': 'OTHER_GOV'}, 'collaborators': [{'name': 'Chinese Academy of Medical Sciences', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'coronary heart disease center', 'investigatorFullName': 'Yongjian Wu', 'investigatorAffiliation': 'China National Center for Cardiovascular Diseases'}}}}