NCT03159923已完成不适用
Cardiac Remodeling and Prognosis in Secondar Tricuspid Regurgitation
Rennes University Hospital17 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2017年1月19日最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 200
- 试验地点
- 17
- 主要终点
- Composite criteria : cardiovascular death or unscheduled hospitalizations due to cardiovascular event.
研究概览
简要总结
The aim of this study is to improve the definition of the two main types of secondary tricuspid regurgitation.
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
- •Any patients ≥ 18 years old, with moderate to severe tricuspid regurgitation (≥ 2/4), agreeing to participate ;
- •The patients included can be ambulatory patients or stabilized hospitalised patients (meaning patient clinicaly stable, not decompensated, and whose normovolemia has been checked).
- •Non opposition of the patient
排除标准
- •Patient whose accoustic window is judged by the operator as incompatible with a precise evaluation of the tricuspid regurgitation or anatomy of the right cavity ;
- •TR < grade 2 ;
- •TR secondary to primary pulmonary hypertension or congenital cardiopathy ;
- •Primary tricuspid regurgitation (due to rheumatic heart disease, medication - included benfluorex, due to endocarditis, valvular prolapse, carcinoid syndrom or a cardiac stimulation lead ...) ;
- •Significant left heart valvulopathy (Mitral regurgitation > grade 2, Aortic insufficiency > grade 2, Mitral stenosis < 2 cm², Aortic stenosis < 1.5 cm²). A valvulopathy sucessfully operated isn't considered as an exclusion criteria;
- •Cardiopathy with significative systolic dysfunction (FE< 40%) ;
- •Patients whose life expectantcy is less than 1 year due to a pathology independent of the TR (neoplasic process for example) ;
- •Patient under judicial protection.
结局指标
主要结局
Composite criteria : cardiovascular death or unscheduled hospitalizations due to cardiovascular event.
时间窗: through study completion, an average of 1 year
次要结局
未报告次要终点
研究者
研究点 (17)
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