跳至主要内容
临床试验/NCT03279029
NCT03279029暂停不适用

Aortic Valve Regurgitation Acquired After Left Ventricular Assist Device Implantation: an Outstanding in Vivo Model of Valvular Heart Diseases

Assistance Publique Hopitaux De Marseille2 个研究点 分布在 1 个国家目标入组 15 人开始时间: 2017年9月14日最近更新:
适应症

试验速览

阶段
不适用
状态
暂停
入组人数
15
试验地点
2
主要终点
blood sample

研究概览

简要总结

To investigate histological structure and molecular changes involved on the onset of AVD after left ventricular assist device (LVAD) implantation and to compare them with those of patients operated on for severe aortic regurgitation.

Methods: Bridge-to-transplant patients with AVD post-LVAD implantation are included. Patients operated on for severe aortic regurgitation are included as control. Clinical and TTE data are compiled. Samples of aortic valve are collected at the time of the intervention. RNA-sequencing analysis is performed in LVAD patients and variations of gene expression are validated by real time qPCR in both. Blood sampling are performed pre-operatively and at one-month follow up to assess the plasma level of previously identified gene modulators. In-vitro studies exposing VICs and VECs to several mechanical stimuli are performed for validation.

Conclusion(s) Taking together, the in-vivo and in-vitro models would provide important information for the understanding of valve remodeling and disease. ECM gene modulators could represent pertinent molecular targets to stop the progression of AVD

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

入选标准

  • Patients with long-term left-ventricular assistance awaiting transplant
  • Patients with severe aortic surgical spring deficiency
  • Major Patient

排除标准

  • Minor Patient
  • Pregnant or nursing women
  • Major under guardianship
  • People in emergencies
  • Persons not covered by the social security scheme

结局指标

主要结局

blood sample

时间窗: 24 months

RNA-sequencing analysis

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 (2)

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