NCT05920824招募中不适用
Clinical Phenotypes, Risk Factors, & Determinants of Outcome in Functional Mitral and Tricuspid Valve Regurgitation
适应症
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Effective Regurgitant Orifice Area at 1 year
研究概览
简要总结
A prospective, observational cohort study designed to identify clinical phenotypes and evaluate predictors & outcomes of functional mitral and tricuspid valve regurgitation in patients with atrial fibrillation.
Participant will under go:
- Baseline echocardiography
- Cpex Echocardiography
- Blood test: BNP
- 1 year follow up Echocardiography
Participants will be stratified into three subgroups:
- Atrial Functional MR
- Atrial Functional TR
- Mixed MR & TR
详细描述
Rationale
The natural history and risk factors for atrial valve disease are poorly understood and characterised. This study will examine differences between atrial mitral and atrial tricuspid disease and help us understand the natural history of these pathologies.
Study objectives
Primary objective
- Identify & characterise phenotypes in functional mitral and tricuspid valve regurgitation
- Identify risk factors for progression of disease and outcome.
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
- •Informed consent
- •Age of 18 years or older
- •Atrial fibrillation
- •Moderate or severe atrial valve disease
- •Adequate 2D echocardiography views including parasternal long axis, short axis, apical two chamber, apical three chamber and four chamber.
排除标准
- •Unwilling or unable to give consent
- •Left ventricular impairment (ejection fraction < 50%).
- •Primary/organic valve disease
结局指标
主要结局
Effective Regurgitant Orifice Area at 1 year
时间窗: 1 year
Measure the EROA by echocardiography after 1 year
次要结局
- Heart Failure admission within 1 year of recruitment.(1 year)
- Mortality(1 year)
- Functional: New York Heart Association Class, Predicted VO2max (<84%).(1 year)
- Progression of valve disease defined as worsening of mitral or tricuspid regurgitation > 1 grade at 1 year.(1 year)
研究者
研究点 (1)
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