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Valvular Heart Disease Registry Study in Second Affiliated Hospital of ZheJiang University (VHD-ZJU)

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ClinicalTrials.gov Identifier: NCT03011697
Recruitment Status : Not yet recruiting
First Posted : January 5, 2017
Last Update Posted : January 5, 2017
Sponsor:
Information provided by (Responsible Party):
Second Affiliated Hospital, School of Medicine, Zhejiang University

Brief Summary:
Valvular heart disease (VHD) is becoming more and more frequent with the aging, which has brought a heavy burden to the world. However, the prevalence and prognosis of valvular heart disease are not so clear, especially in the developing countries such as China etc. Because of the slow and progressive nature of VHD, symptoms might not be too severe to be diagnosed on time. Our retrospective survey (Int J Cardiol. 2016 Nov 25) indicated that severe valvular diseases are very common in China. Hence, we design a prospective, observational cohort study to provide contemporary information on the prevalence, characteristics, risk stratification,cost-effective ,treatments and prognosis of Chinese hospitalised adult patients with valvular heart disease.

Condition or disease
Valvular Heart Disease

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Study Type : Observational
Estimated Enrollment : 10000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective, Single-center,Registry Study of Chinese Hospitalized Adult Patients With Valvular Heart Disease
Study Start Date : January 2017
Estimated Primary Completion Date : December 2026
Estimated Study Completion Date : December 2027

Resource links provided by the National Library of Medicine





Primary Outcome Measures :
  1. All-cause mortality and disabling strokes [ Time Frame: one year ]

Secondary Outcome Measures :
  1. Hospitalization for heart failure [ Time Frame: one year ]
  2. Surgical or transcatheter aortic valve replacement [ Time Frame: one year ]


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
10000 hospitalized patients over 18 years old with valvular heart disease will be enrolled consecutively
Criteria

Inclusion Criteria:

Hospitalized patients over 18 years old meet one of the following conditions.

  1. moderate or above valvular heart disease as defined by echocardiography: 1.1 Aortic stenosis, moderate or above, or valve area ≤1.5cm2, or maximal jet velocity ≥3.0m/sec, or mean pressure gradient ≥20mmHg, 1.2 Aortic regurgitation, moderate or above, or jet width ≥25% of left ventricular outflow tract, or regurgitant volume ≥30ml/beat, or regurgitant fraction ≥30%, 1.3 Mitral stenosis, moderate or above, or valve area ≤2.0cm2, 1.4 Mitral regurgitation, moderate or above, or effective regurgitant orifice ≥0.2cm2, or regurgitant volume ≥30ml/beat, or regurgitant fraction ≥30%, 1.5 Tricuspid stenosis, moderate or above, or valve area ≤1.0cm2, 1.6 Tricuspid regurgitation, moderate or above, or central jet area ≥5.0cm2, 1.7 Pulmonic stenosis, moderate or above, or maximal jet velocity >4m/sec, 1.8 Pulmonic regurgitation, moderate or above,
  2. Patients who had undergone any operation on a cardiac valve (percutaneous balloon commissurotomy, valve repair, valve replacement, transcatheter aortic valve implantation),
  3. Diagnosis of endocarditis as assessed by Duke criteria.

Exclusion Criteria:

  1. Patients cannot be followed up for any reasons.
  2. Patients in critical condition may be die in one year.
  3. 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): NCT03011697


Contacts
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Contact: Liu Xianbao, MD +86-13857173887 liuxb2009@hotmail.com
Contact: Wang Jian-an, MD,PhD +86-13805786328 jian_an_wang@yahoo.com

Locations
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China, Zhejiang
2nd Affiliated Hospital, School of Medicine at Zhejiang University Not yet recruiting
Hangzhou, Zhejiang, China, 310000
Contact: Liu Xianbao, MD    +86-13857173887    liuxb2009@hotmail.com   
Contact: Wang Jian-an, MD,PhD    +86-13805786328    jian_an_wang@yahoo.com   
Principal Investigator: Wang Jian-an, MD,PhD         
Sponsors and Collaborators
Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
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Principal Investigator: Wang Jian-an, MD,PhD Second Affiliated Hospital Zhejiang University School of Medicine

Additional Information:
Publications:
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Responsible Party: Second Affiliated Hospital, School of Medicine, Zhejiang University
ClinicalTrials.gov Identifier: NCT03011697     History of Changes
Other Study ID Numbers: SAHZJU CT010
First Posted: January 5, 2017    Key Record Dates
Last Update Posted: January 5, 2017
Last Verified: December 2016

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