A Prospective, Single-center,Registry Study of Chinese Hospitalized Adult Patients With Valvular Heart Disease
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 10,000
- 试验地点
- 1
- 主要终点
- All-cause mortality and disabling strokes
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized patients over 18 years old meet one of the following conditions.
- •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,
- •Patients who had undergone any operation on a cardiac valve (percutaneous balloon commissurotomy, valve repair, valve replacement, transcatheter aortic valve implantation),
- •Diagnosis of endocarditis as assessed by Duke criteria.
排除标准
- •Patients cannot be followed up for any reasons.
- •Patients in critical condition may be die in one year.
- •Patients have been enrolled in this study.
结局指标
主要结局
All-cause mortality and disabling strokes
时间窗: one year
All-cause mortality and disabling strokes
次要结局
- Surgical or transcatheter aortic valve replacement(one year)
- Hospitalization for heart failure(one year)
研究者
Jian'an Wang,MD,PhD
President of Second Affiliated Hospital, School of Medicine, Zhejiang University & Chief of Cardiology
Second Affiliated Hospital, School of Medicine, Zhejiang University