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出境医 / 临床实验 / Endothelial Function and Circulating Microparticle in Patients Under LVAD Support (MP-LVAD)

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

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 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.

Study Design
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
Arms and Interventions
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

Outcome Measures
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

Eligibility Criteria
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
Contacts and Locations

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
Tracking Information
First Submitted Date April 12, 2019
First Posted Date April 22, 2019
Last Update Posted Date June 21, 2019
Actual Study Start Date May 1, 2017
Actual Primary Completion Date May 31, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 18, 2019)
Occurrence of thrombemboic events during 12 month [ Time Frame: 12 month ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: April 18, 2019)
  • Endothelial function [ Time Frame: Baseline ]
    Flow mediated dilatation measured by ultrasound
  • Level of circulating mircoparticles [ Time Frame: Baseline ]
    measured and discriminated by FACS and ELISA
  • microparticle induced thrombin generation [ Time Frame: Baseline ]
    measured and discriminated by FACS and ELISA
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Endothelial Function and Circulating Microparticle in Patients Under LVAD Support
Official Title Endothelial Function and Circulating Microparticle in Patients Under LVAD Support
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
3ml venous blood
Sampling Method Non-Probability Sample
Study Population Patients in the heart failure program of the University of Duesseldorf
Condition End Stage Heart Failure
Intervention Other: Blood samples
Blood samples for MP evaluation
Study Groups/Cohorts
  • patients with chronic heart failure without LVAD support
    patients with chronic heart failure without LVAD support
    Intervention: Other: Blood samples
  • patients with end-stage heart failure with LVAD support
    patients with end-stage heart failure with LVAD support
    Intervention: Other: Blood samples
Publications * Kramser N, Oehler D, Saeed D, Aubin H, Akhyari P, Kelm M, Westenfeld R, Horn P. Thromboembolic Events in Patients With Left Ventricular Assist Devices Are Related to Microparticle-Induced Coagulation. ASAIO J. 2021 Jan 1;67(1):59-66. doi: 10.1097/MAT.0000000000001200.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: April 18, 2019)
65
Original Estimated Enrollment Same as current
Actual Study Completion Date May 31, 2019
Actual Primary Completion Date May 31, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • current thrombembolic or bleeding event
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers Not Provided
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Germany
Removed Location Countries  
 
Administrative Information
NCT Number NCT03923413
Other Study ID Numbers 14-018
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Undecided
Responsible Party Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
Study Sponsor Heinrich-Heine University, Duesseldorf
Collaborators Not Provided
Investigators Not Provided
PRS Account Heinrich-Heine University, Duesseldorf
Verification Date June 2019