VHD-ZJU: Valvular Heart Disease Registry Study in Second Affiliated Hospital of ZheJiang University
Study Details
Study Description
Brief Summary
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 | Intervention/Treatment | Phase |
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Detailed Description
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.
Study Design
Outcome Measures
Primary Outcome Measures
- All-cause mortality and disabling strokes [one year]
All-cause mortality and disabling strokes
Secondary Outcome Measures
- Hospitalization for heart failure [one year]
Hospitalization for heart failure
- Surgical or transcatheter aortic valve replacement [one year]
Surgical or transcatheter aortic valve replacement
Eligibility Criteria
Criteria
Inclusion Criteria:
Hospitalized patients over 18 years old meet one of the following conditions.
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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,
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Patients who had undergone any operation on a cardiac valve (percutaneous balloon commissurotomy, valve repair, valve replacement, transcatheter aortic valve implantation),
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Diagnosis of endocarditis as assessed by Duke criteria.
Exclusion Criteria:
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Patients cannot be followed up for any reasons.
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Patients in critical condition may be die in one year.
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Patients have been enrolled in this study.
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | 2nd Affiliated Hospital, School of Medicine at Zhejiang University | Hangzhou | Zhejiang | China | 310000 |
Sponsors and Collaborators
- Second Affiliated Hospital, School of Medicine, Zhejiang University
Investigators
- Principal Investigator: Wang Jian-an, MD,PhD, Second Affiliated Hospital Zhejiang University School of Medicine
Study Documents (Full-Text)
None provided.More Information
Additional Information:
Publications
- SAHZJU CT010