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临床试验/NCT04268160
NCT04268160撤回不适用

Glutathione Peroxidase Activity in Subjects With Aortic Stenosis Undergoing Transcatheter Aortic Valve Replacement.

University of Florida1 个研究点 分布在 1 个国家开始时间: 2020年11月最近更新:
适应症

试验速览

阶段
不适用
状态
撤回
试验地点
1
主要终点
Level of GPx in blood samples

研究概览

简要总结

The aim of this project is to investigate the association of glutathione peroxidase (GPx) and severe aortic stenosis (AS), as well as the impact of transcatheter aortic valve replacement (TAVR) on GPx activity post-procedure. The burden of oxidative stress will be determined by the measurement of GPx, superoxide dismutase (SOD) and lipoprotein A (Lp(a)). We hypothesize GPx activity is reduced in participants with severe AS vs control groups and GPx activity is to increase after TAVR is performed.

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

入选标准

  • Age >18 years
  • Patients with severe AS including participants with low flow, low gradient severe AS and paradoxical severe AS
  • Patients meeting criteria for TAVR procedure

排除标准

  • Previous aortic valve replacement (surgical or TAVR)
  • Participants undergoing chemotherapy
  • End stage liver disease/cirrhosis (liver produces GSH)

结局指标

主要结局

Level of GPx in blood samples

时间窗: Baseline up to 6 months

Glutathione peroxidase activity levels measured from whole blood in U/L units in participants with severe aortic stenosis after transcatheter valve replacement compared with the matched population

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (1)

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