Endothelial Function and Circulating Microparticle in Patients Under LVAD Support

Study Overview
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Brief Summary
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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
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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.

Official Title
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Endothelial Function and Circulating Microparticle in Patients Under LVAD Support

Conditions
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End Stage Heart Failure

Intervention / Treatment
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* Other: Blood samples


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Inclusion Criteria: chronic heart failure INTERMASC 5-7 or Patients on LVAD support Exclusion Criteria: current thrombembolic or bleeding event

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| patients with chronic heart failure without LVAD support<br>patients with chronic heart failure without LVAD support | Other: Blood samples<br>* Blood samples for MP evaluation<br>|
| patients with end-stage heart failure with LVAD support<br>patients with end-stage heart failure with LVAD support | Other: Blood samples<br>* Blood samples for MP evaluation<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of thrombemboic events during 12 month |  | 12 month | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Endothelial function | Flow mediated dilatation measured by ultrasound | Baseline | 
| Level of circulating mircoparticles | measured and discriminated by FACS and ELISA | Baseline | 
| microparticle induced thrombin generation | measured and discriminated by FACS and ELISA | Baseline | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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circulating MP, FMD, LVAD, endothelial function, endothelial integrity