Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Endothelial Function and Circulating Microparticle in Patients Under LVAD Support (MP-LVAD)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03923413
Recruitment Status : Completed
First Posted : April 22, 2019
Last Update Posted : June 21, 2019
Sponsor:
Information provided by (Responsible Party):
Klinik für Kardiologie, Pneumologie und Angiologie, 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.

Condition or disease Intervention/treatment
End Stage Heart Failure Other: Blood samples

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.

Layout table for study information
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 1, 2017
Actual Primary Completion Date : May 31, 2019
Actual Study Completion Date : May 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort 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




Primary Outcome Measures :
  1. Occurrence of thrombemboic events during 12 month [ Time Frame: 12 month ]

Secondary Outcome Measures :
  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


Biospecimen Retention:   Samples Without DNA
3ml venous blood


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03923413


Locations
Layout table for location information
Germany
Heinrich-Heine-University, Div. of Cardiology, Pulmonary Disease and Vascular Medicine
Dusseldorf, NRW, Germany, 40225
Sponsors and Collaborators
Heinrich-Heine University, Duesseldorf
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Layout table for additonal information
Responsible Party: Klinik für Kardiologie, Pneumologie und Angiologie, Dr.med. Patrick Horn, Principle Investigator, Heinrich-Heine University, Duesseldorf
ClinicalTrials.gov Identifier: NCT03923413    
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf:
circulating MP
FMD
LVAD
endothelial function
endothelial integrity
Additional relevant MeSH terms:
Layout table for MeSH terms
Heart Failure
Heart Diseases
Cardiovascular Diseases