Endothelial Function and Circulating Microparticle in Patients Under LVAD Support

Completed

• Conditions: End Stage Heart Failure

• Registration Number: NCT03923413
• Lead Sponsor: Heinrich-Heine University, Duesseldorf

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 Timeline

• Study Start: 2017-05-01
• Study First Submitted: 2019-04-12
• Study First Submitted QC: 2019-04-18
• Study First Posted: 2019-04-22
• Primary Completion: 2019-05-31
• Study Completion: 2019-05-31
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-19
• Last Update Posted: 2019-06-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

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

Exclusion Criteria

• current thrombembolic or bleeding event

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Occurrence of thrombemboic events during 12 month	12 month

Secondary Outcome Measures

Name	Time	Method
Level of circulating mircoparticles	Baseline	measured and discriminated by FACS and ELISA
Endothelial function	Baseline	Flow mediated dilatation measured by ultrasound
microparticle induced thrombin generation	Baseline	measured and discriminated by FACS and ELISA

Trial Locations

Locations (1)

Heinrich-Heine-University, Div. of Cardiology, Pulmonary Disease and Vascular Medicine; 🇩🇪 Dusseldorf, NRW, Germany