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临床试验/NCT03923413
NCT03923413
已完成
不适用

Endothelial Function and Circulating Microparticle in Patients Under LVAD Support

Heinrich-Heine University, Duesseldorf1 个研究点 分布在 1 个国家目标入组 65 人2017年5月1日

概览

阶段
不适用
干预措施
未指定
疾病 / 适应症
End Stage Heart Failure
发起方
Heinrich-Heine University, Duesseldorf
入组人数
65
试验地点
1
主要终点
Occurrence of thrombemboic events during 12 month
状态
已完成
最后更新
6年前

概览

简要总结

The aims of this project are 1) to evaluate whether circulating micraparticals (MPs) in patients with LVAD impair endothelial function and 2) to assess the procoagulative activity of circulating MPs in patients with LVAD in a prospective longitudinal study of patients undergoing LVAD implantation, 3) to analyze these parameters in the context of thromboembolic events.

详细描述

Continuous-flow left ventricular assist devices (LVADs) have arised as a vital therapeutic option in end stage heart failure not merely as bridge-to transplant but also as destination therapy. LVADs are associated with impaired endothelial function as well as with a dysbalance of coagulation leading to both, excessive bleeding and thromboembolic events, respectively. Microparticles (MPs) are shed membrane particles budded into the circulation and considered as a marker of compromised endothelial integrity and enhanced procoagulation levels. In addition, MPs have been suggested to play an active role in the induction of endothelial dysfunction and coagulation. First studies demonstrated increased level of MPs in patients with LVAD. Whether circulating MPs contribute to impaired endothelial function and enhanced coagulation in patients with LVAD and thereby promote thrombotic complications is unknown. The aims of this project are 1) to evaluate whether circulating MPs in patients with LVAD impair endothelial function and 2) to assess the procoagulative activity of circulating MPs in patients with LVAD in a prospective longitudinal study of patients undergoing LVAD implantation, 3) to analyze these parameters in the context of thromboembolic events.

注册库
clinicaltrials.gov
开始日期
2017年5月1日
结束日期
2019年5月31日
最后更新
6年前
研究类型
Observational
性别
All

研究者

发起方
Heinrich-Heine University, Duesseldorf
责任方
Principal Investigator
主要研究者

Klinik für Kardiologie, Pneumologie und Angiologie

Dr.med. Patrick Horn, Principle Investigator

Heinrich-Heine University, Duesseldorf

入排标准

入选标准

  • Inclusion Criteria: chronic heart failure INTERMASC 5-7 or
  • Patients on LVAD support

排除标准

  • current thrombembolic or bleeding event

结局指标

主要结局

Occurrence of thrombemboic events during 12 month

时间窗: 12 month

次要结局

  • Level of circulating mircoparticles(Baseline)
  • Endothelial function(Baseline)
  • microparticle induced thrombin generation(Baseline)

研究点 (1)

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