Aortic Stenosis: Determinants and Prognostic Value of Preoperative Left Ventricular Remodeling After Valvular Replacement (AS-INTERVENTION)
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 发起方
- 入组人数
- 440
- 试验地点
- 1
- 主要终点
- Occurrence of clinical events according to left ventricular remodeling
研究概览
简要总结
Aortic stenosis (AS) is the most frequent valvulopathy in Western countries. The prevalence of AS is constantly increasing due to the aging of the population. Although significant progress has been made in understanding the pathophysiological mechanisms underlying the onset and progression of AS, there is no medical treatment to slow or prevent its progression. The only treatment available is Aortic Valve Replacement (AVR) performed by surgery or by catheterization (TAVI).
AS is associated with an increase of post-load which leads the left ventricular myocardium to hypertrophy. Associated with hypertrophy, myocardial fibrosis will gradually develop. Despite interesting data, many unknowns persist and remain to be identified.
The aim of the study is to characterize prospectively the left ventricular remodeling and assess its changes after AVR and within 1 year in 500 patients using clinical, biological, echocardiographic and MRI parameters.
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
- •Aortic stenosis
- •Indication of Aortic Valve Replacement (Surgery or TAVI)
排除标准
- •Rheumatismal or congenital aortic stenosis
- •Aortic insufficiency (grade >= 2/4)
- •Associated valvulopathy (grade >= 2/4)
- •Myocardial infarction antecedent
- •Severe renal failure
- •Cardiac surgery (Aorta abdominal) antecedent
- •Complex congenital cardiopathy
结局指标
主要结局
Occurrence of clinical events according to left ventricular remodeling
时间窗: Year 4
Echocardiography and MRI
次要结局
- Evolution of left ventricular remodeling after aortic valvular replacement(Year 1)
- Prognostic value of fibrosis(Year 1)
- Prognostic value of biomarkers(Year 1)
- Prognostic value of persistence and type of left ventricular remodeling(Year 1)