Third National Multicenter Registered Cohort Study of Hospitalized Elderly Patients With Valvular Heart Disease Based on the China-DVD Network
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 6,612
- 试验地点
- 1
- 主要终点
- First valve intervention during this hospitalization
研究概览
简要总结
This study aims to conduct a second round of multicenter, prospective registry research targeting elderly patients with valvular heart disease, to understand the current status of interventions for patients with valvular heart disease. To systematically evaluate the distribution of types, clinical characteristics, interventions, and complications of elderly valvular heart disease, and to compare and analyze these with the China-DVD data from 2016, thereby revealing its evolutionary trends. By comprehensively considering various clinical characteristics such as different types of valvular lesions, treatment modalities, patient cardiac function, comorbidities, and blood test indicators, as well as multidimensional factors including psychological and lifestyle aspects, to deeply identify the key determinants influencing the treatment of elderly valvular heart disease patients in China, and thus optimize and improve their individualized comprehensive management pathways.
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
- 60 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Hospitalized patients over 60 years old meet one of the following conditions.
- •1、 moderate or above valvular heart disease as defined by echocardiography: One of the following criteria
- •(1)Mitral stenosis : Valve area ≤1.5 cm², or mean pressure gradient ≥10 mmHg.
- •(2)Mitral regurgitation : Moderate and above regurgitation, or regurgitant jet width ≥ 3 mm, or regurgitant volume per beat ≥ 30 ml, or regurgitant jet area/left atrial area > 20%; or effective regurgitant orifice area (EROA) ≥ 20 mm²
- •(3)Aortic stenosis : Moderate and above, mean pressure gradient ≥ 20 mmHg, or peak jet velocity ≥ 3 m/s, or valve area ≤ 1.5 cm²
- •(4)Aortic regurgitation : Moderate and above regurgitation, or regurgitant jet width ≥ 3 mm, or regurgitant volume per beat ≥ 30 ml, or regurgitant fraction ≥ 30%, or jet width occupying ≥ 25% of the left ventricular outflow tract, or effective regurgitant orifice area (EROA) ≥ 10 mm²
- •(5)Tricuspid stenosis : Moderate and above
- •(6)Tricuspid regurgitation : Moderate and above regurgitation, or jet area ≥ 5 cm²
- •(7)Pulmonary stenosis : Moderate and above
- •(8）Pulmonary regurgitation : Moderate and above regurgitation 2 、Previous history of cardiac valve surgery or interventional therapy (dilation, valvuloplasty, valve replacement) 3、Diagnosed with infective endocarditis
排除标准
- •Patients unwilling to accept registration and follow-up;
- •Patients with mental illness who cannot cooperate with information collection and follow-up Patients have been enrolled in this study.
研究组 & 干预措施
China elderly Valve Disease Study III (China-DVD3 study)
This study aims to conduct a second round of multicenter, prospective registry research targeting elderly patients with valvular heart disease, to understand the current status of interventions for patients with valvular heart disease. To systematically evaluate the distribution of types, clinical characteristics, interventions, and complications of elderly valvular heart disease, and to compare and analyze these with the China-DVD data from 2016, thereby revealing its evolutionary trends. By comprehensively considering various clinical characteristics such as different types of valvular lesions, treatment modalities, patient cardiac function, comorbidities, and blood test indicators, as well as multidimensional factors including psychological and lifestyle aspects, to deeply identify the key determinants influencing the treatment of elderly valvular heart disease patients in China, and thus optimize and improve their individualized comprehensive management pathways.
结局指标
主要结局
First valve intervention during this hospitalization
时间窗: From enrollment to the end of treatment at 12 weeks
Underwent their first internal medicine intervention or surgical procedure during hospitalization for valvular heart disease in this study
次要结局
- 1、Repeat valve intervention 2、Cardiovascular adverse events(From enrollment to the 12-month follow-up endpoint)
研究者
Yongjian Wu, MD, PhD
Director of Coronary Heart Disease Center
China National Center for Cardiovascular Diseases