NCT03923413

Endothelial Function and Circulating Microparticle in Patients Under LVAD Support

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 65 (actual)
• Sponsor: Heinrich-Heine University, Duesseldorf · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: —

Summary

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.

Detailed description

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.

Conditions

• End Stage Heart Failure

Interventions

Type	Name	Description
OTHER	Blood samples	Blood samples for MP evaluation

Timeline

• Start date: 2017-05-01
• Primary completion: 2019-05-31
• Completion: 2019-05-31
• First posted: 2019-04-22
• Last updated: 2019-06-21

Locations

1 site across 1 country: Germany