Endothelial Function and Circulating Microparticle in Patients Under LVAD Support

NCT ID: NCT03923413

Last Updated: 2019-06-21

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 65 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2017-05-01
• Study Completion Date: 2019-05-31

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.

Conditions

End Stage Heart Failure

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

patients with chronic heart failure without LVAD support

patients with chronic heart failure without LVAD support

Blood samples

Intervention Type: OTHER

Blood samples for MP evaluation

patients with end-stage heart failure with LVAD support

patients with end-stage heart failure with LVAD support

Blood samples

Intervention Type: OTHER

Blood samples for MP evaluation

Interventions

Blood samples

Blood samples for MP evaluation

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients on LVAD support

Exclusion Criteria

• current thrombembolic or bleeding event

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Heinrich-Heine University, Duesseldorf

OTHER

Sponsor Role: lead

Responsible Party

Klinik für Kardiologie, Pneumologie und Angiologie

Dr.med. Patrick Horn, Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

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

Düsseldorf, North Rhine-Westphalia, Germany

Countries

Germany

References

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.

Reference Type: DERIVED

PMID: 33346991 (View on PubMed)

Other Identifiers

14-018

Identifier Type: -

Identifier Source: org_study_id