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Registration and Cohort Study of Valvular Heart Disease in Adults in China (China-VHD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03484806
Recruitment Status : Recruiting
First Posted : April 2, 2018
Last Update Posted : February 15, 2019
Sponsor:
Collaborator:
Chinese Academy of Medical Sciences
Information provided by (Responsible Party):
Yongjian Wu, China National Center for Cardiovascular Diseases

Brief Summary:
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.

Condition or disease
Valvular Heart Disease

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Study Type : Observational [Patient Registry]
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 2 Years
Official Title: China Registry and Cohort Study of Valvular Heart Disease in Adults
Actual Study Start Date : April 1, 2018
Estimated Primary Completion Date : September 1, 2020
Estimated Study Completion Date : October 1, 2020

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. all-cause mortality [ Time Frame: 2years ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
patients over 60 years old with significant VHD
Criteria

Inclusion Criteria:

  • patients over 60 years old meet one of the following conditions.

    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,
    2. or patients who had undergone any operation on a cardiac valve (percutaneous balloon commissurotomy, valve repair, valve replacement, transcatheter aortic valve implantation),
    3. or diagnosis of endocarditis as assessed by Duke criteria.

Exclusion Criteria:

  • Patients cannot be followed up for any reasons. Patients have been enrolled in this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03484806


Contacts
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Contact: haiyan xu, doctor +86 13681012249 xuhaiyan@fuwaihospital.org
Contact: yunqing ye, master +86 13699282532 judia8510@163.com

Locations
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China, Beijing
Fuwai Hospital, National Center for Cardiovascular Diseases,Chinese Academy of Medical Sciences Recruiting
Beijing, Beijing, China, 100037
Contact: haiyan xu, doctor    +86 13681012249    xuhaiyan@fuwaihospital.org   
Contact: yongjian wu, doctor    +86 13701387189    fuwaihospital@hotmail.com   
Sponsors and Collaborators
China National Center for Cardiovascular Diseases
Chinese Academy of Medical Sciences
Investigators
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Study Chair: yongjian wu, doctor Fuwai Hospital, National Center for Cardiovascular Diseases,Chinese Academy of Medical Sciences
Principal Investigator: haiyan xu, doctor Fuwai Hospital, National Center for Cardiovascular Diseases,Chinese Academy of Medical Sciences

Additional Information:

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Responsible Party: Yongjian Wu, coronary heart disease center, China National Center for Cardiovascular Diseases
ClinicalTrials.gov Identifier: NCT03484806     History of Changes
Other Study ID Numbers: 2017-I2M-3-002
First Posted: April 2, 2018    Key Record Dates
Last Update Posted: February 15, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Heart Diseases
Heart Valve Diseases
Cardiovascular Diseases