Endothelial Function and Circulating Microparticle in Patients Under LVAD Support

End Stage Heart Failure Clinical Trial

— MP-LVAD  

Official title:

Endothelial Function and Circulating Microparticle in Patients Under LVAD Support

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03923413
• Other study ID #: 14-018
• Status: Completed
• Start date: May 1, 2017
• Est. completion date: May 31, 2019

Study information

• Verified date: June 2019
• Source: Heinrich-Heine University, Duesseldorf
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 65
• Est. completion date: May 31, 2019
• Est. primary completion date: May 31, 2019
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Inclusion Criteria: chronic heart failure INTERMASC 5-7 or

• Patients on LVAD support

Exclusion Criteria:

• current thrombembolic or bleeding event

Related Conditions & MeSH terms

• End Stage Heart Failure
• Heart Failure

Intervention

Other:
• Blood samples
Blood samples for MP evaluation

Locations

Country	Name	City	State
Germany	Heinrich-Heine-University, Div. of Cardiology, Pulmonary Disease and Vascular Medicine	Dusseldorf	NRW

Sponsors (1)

Lead Sponsor	Collaborator
Heinrich-Heine University, Duesseldorf

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Occurrence of thrombemboic events during 12 month		12 month
Secondary	Endothelial function	Flow mediated dilatation measured by ultrasound	Baseline
Secondary	Level of circulating mircoparticles	measured and discriminated by FACS and ELISA	Baseline
Secondary	microparticle induced thrombin generation	measured and discriminated by FACS and ELISA	Baseline