Clinical trial NCT03923413: Endothelial Function and Circulating Microparticle in Patients Under LVAD Support
Official title: Endothelial Function and Circulating Microparticle in Patients Under LVAD Support
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: End Stage Heart Failure
Keywords: circulating MP
FMD
LVAD
endothelial function
endothelial integrity
Lead sponsor: Heinrich-Heine University, Duesseldorf
Sponsor class: OTHER
First posted: 2019-04-22
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients in the heart failure program of the University of 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.

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.

Eligibility criteria: Inclusion Criteria:

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

Exclusion Criteria:

* current thrombembolic or bleeding event

Primary outcomes:
measure: Occurrence of thrombemboic events during 12 month
timeFrame: 12 month
Secondary outcomes:
measure: Endothelial function
timeFrame: Baseline
measure: Level of circulating mircoparticles
timeFrame: Baseline
measure: microparticle induced thrombin generation
timeFrame: Baseline
Other outcomes:
Locations:
city: Dusseldorf
country: Germany
facility: Heinrich-Heine-University, Div. of Cardiology, Pulmonary Disease and Vascular Medicine
state: NRW
Study officials:
References:
citation: 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.