Prognostic Impact of the Evolution of Pulmonary Arterial Hypertension 3 Months After Transcatheter Aortic Valve Implantation
试验速览
- 阶段
- 不适用
- 状态
- 终止
- 发起方
- 入组人数
- 101
- 试验地点
- 2
- 主要终点
- Hospitalization for heart failure or death any cause (composite endpoint)
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. Several studies have shown that pulmonary arterial hypertension (PAH) was common in AS patients referred for TAVI and that it was an independent predictor of mortality after TAVI.
Currently, there is no data in the literature regarding the evolution and prognosis value of PAH measured using right heart catheterization (reference method). PAH could either regress after TAVI or continue to progress despite the treatment of valvulopathy, resulting in a refractory right heart failure that can lead to death.
The hypothesis of this study is that patients with PAH before TAVI procedure and at the 3-month follow-up visit (PAH persistence) have an increased risk of cardiovascular mortality compared to patients with no PAH at 3 months or having a significant reduction of their PAH (PAH regression).
The aim of the study is to evaluate the prognostic impact of the evolution of PAH after TAVI in 424 patients using right heart catheterization.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- None
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 TAVI
排除标准
- •Contra-indication of right heart catheterization
- •Pregnancy
- •Persons deprived of their liberty
结局指标
主要结局
Hospitalization for heart failure or death any cause (composite endpoint)
时间窗: Up to 24 months
Time before the first event (hospitalization or death any cause)
次要结局
- Hospital-free survival for heart failure among the 3 types of PAH (pre-TAVI)(Year 2)
- Prevalence of pre-TAVI PAH(Year 0)
- Prognosis (survival without hospitalization for heart failure) of subjects whose PAH corrected post-TAVI to those who had no pre-TAVI PAH(Month 3)
- Concordance between the PAH measurement techniques: echocardiography and right heart catheterization(Month 3)
- Post-operative evolution of the PAH, according to the type of pre-operative PAH(Year 2)