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Endothelial Function and Circulating Microparticle in Patients Under LVAD Support

Endothelial Function and Circulating Microparticle in Patients Under LVAD Support

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03923413
Acronym
MP-LVAD
Enrollment
65
Registered
2019-04-22
Start date
2017-05-01
Completion date
2019-05-31
Last updated
2019-06-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

End Stage Heart Failure

Keywords

circulating MP, FMD, LVAD, endothelial function, endothelial integrity

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.

Interventions

OTHERBlood samples

Blood samples for MP evaluation

Sponsors

Heinrich-Heine University, Duesseldorf
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum

Inclusion criteria

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

Exclusion criteria

* current thrombembolic or bleeding event

Design outcomes

Primary

MeasureTime frame
Occurrence of thrombemboic events during 12 month12 month

Secondary

MeasureTime frameDescription
Endothelial functionBaselineFlow mediated dilatation measured by ultrasound
Level of circulating mircoparticlesBaselinemeasured and discriminated by FACS and ELISA
microparticle induced thrombin generationBaselinemeasured and discriminated by FACS and ELISA

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026