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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.
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Clinical trial information and results are updated daily from ClinicalTrials.gov. The latest data update was conducted on 01/22/2021.

Endothelial Function and Circulating Microparticle in Patients Under LVAD Support

Clinicaltrials.gov identifier NCT03923413

Recruitment Status Completed

First Posted April 22, 2019

Last update posted June 21, 2019

Study Description

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.

  • Condition or Disease:End Stage Heart Failure
  • Intervention/Treatment: Other: Blood samples
  • Phase: N/A
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
  • Actual Enrollment: 65 participants
  • Observational Model: Cohort
  • Time Perspective: Prospective
  • Official Title: Endothelial Function and Circulating Microparticle in Patients Under LVAD Support
  • Actual Study Start Date: May 2017
  • Actual Primary Completion Date: May 2019
  • Actual Study Completion Date: May 2019
Groups and Cohorts
Groups/Cohorts Intervention/treatment
: patients with chronic heart failure without LVAD support
patients with chronic heart failure without LVAD support
Other: Blood samples
Blood samples for MP evaluation
: patients with end-stage heart failure with LVAD support
patients with end-stage heart failure with LVAD support
Other: Blood samples
Blood samples for MP evaluation
Outcome Measures
  • Primary Outcome Measures: 1. Occurrence of thrombemboic events during 12 month [ Time Frame: 12 month ]
  • Secondary Outcome Measures: 1. Level of circulating mircoparticles [ Time Frame: Baseline ]
    measured and discriminated by FACS and ELISA
  • 2. microparticle induced thrombin generation [ Time Frame: Baseline ]
    measured and discriminated by FACS and ELISA
  • 3. Endothelial function [ Time Frame: Baseline ]
    Flow mediated dilatation measured by ultrasound
  • Biospecimen Retention: Samples Without DNA

    3ml venous blood

Eligibility Criteria
  • Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
  • Sexes Eligible for Study: All
  • Accepts Healthy Volunteers:
  • Sampling Method: Non-Probability Sample
  • Study Population: Patients in the heart failure program of the University of Duesseldorf
Criteria

Inclusion Criteria:

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

- Patients on LVAD support

Exclusion Criteria:

- current thrombembolic or bleeding event

Contacts and Locations
Contacts
Locations

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

Sponsors and Collaborators

Heinrich-Heine University, Duesseldorf

More Information
  • Responsible Party: Heinrich-Heine University, Duesseldorf
  • ClinicalTrials.gov Identifier: NCT03923413 History of Changes
  • Other Study ID Numbers: 14-018
  • First Posted: April 22, 2019 Key Record Dates
  • Last Update Posted: June 21, 2019
  • Last Verified: June 2019
  • Individual Participant
    Data (IPD) Sharing
    Statement:
  • Plan to Share IPD: Undecided
  • Studies a U.S. FDA-regulated Drug Product: No
  • Studies a U.S. FDA-regulated Device Product: No
  • Keywords provided by Heinrich-Heine University, Duesseldorf: circulating MP
    LVAD
    endothelial function
    endothelial integrity
    FMD
  • Additional relevant MeSH terms: Heart Failure