Endothelial Function and Circulating Microparticle in Patients Under LVAD Support
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 65
- Locations
- 1
- Primary Endpoint
- Occurrence of thrombemboic events during 12 month
Study Overview
Brief 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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Inclusion Criteria: chronic heart failure INTERMASC 5-7 or
- •Patients on LVAD support
Exclusion Criteria
- •current thrombembolic or bleeding event
Outcomes
Primary Outcomes
Occurrence of thrombemboic events during 12 month
Time Frame: 12 month
Secondary Outcomes
- Level of circulating mircoparticles(Baseline)
- Endothelial function(Baseline)
- microparticle induced thrombin generation(Baseline)
Investigators
Klinik für Kardiologie, Pneumologie und Angiologie
Dr.med. Patrick Horn, Principle Investigator
Heinrich-Heine University, Duesseldorf
