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Clinical Trials/NCT03923413
NCT03923413CompletedNot Applicable

Endothelial Function and Circulating Microparticle in Patients Under LVAD Support

Heinrich-Heine University, Duesseldorf1 site in 1 country65 target enrollmentStarted: May 1, 2017Last updated:
Conditions

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

Sponsor
Heinrich-Heine University, Duesseldorf
Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Klinik für Kardiologie, Pneumologie und Angiologie

Dr.med. Patrick Horn, Principle Investigator

Heinrich-Heine University, Duesseldorf

Study Sites (1)

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