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OpenTrials
Completed

NCT Number: NCT03923413

Endothelial Function and Circulating Microparticle in Patients Under LVAD Support

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.

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Key information

Conditions

End Stage Heart Failure

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Heinrich-Heine-University, Div. of Cardiology, Pulmonary Disease and Vascular Medicine

Düsseldorf, North Rhine-Westphalia, 40225, Germany

About this study

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.

Who can participate

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

  • current thrombembolic or bleeding event

Treatment and study plan

Blood Samples

Other

Blood samples for MP evaluation

Primary outcomes

  1. Occurrence of thrombemboic events during 12 month

    Time frame: 12 month

Secondary outcomes

  1. Endothelial function

    Time frame: Baseline

    Flow mediated dilatation measured by ultrasound

  2. Level of circulating mircoparticles

    Time frame: Baseline

    measured and discriminated by FACS and ELISA

  3. microparticle induced thrombin generation

    Time frame: Baseline

    measured and discriminated by FACS and ELISA

Sponsors and collaborators

Lead sponsor

Heinrich-Heine University, Duesseldorf

Other

Registry information

Acronym: MP-LVAD

Important dates

Study start
2017
Primary completion
2019
Study completion
2019
First posted
Apr 22, 2019
Registry last updated
Jun 21, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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