Condition or disease | Intervention/treatment |
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End Stage Heart Failure | Other: Blood samples |
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 |
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 |
Group/Cohort | Intervention/treatment |
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patients with chronic heart failure without LVAD support
patients with chronic heart failure without LVAD support
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Other: Blood samples
Blood samples for MP evaluation
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patients with end-stage heart failure with LVAD support
patients with end-stage heart failure with LVAD support
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Other: Blood samples
Blood samples for MP evaluation
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Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Sampling Method: | Non-Probability Sample |
Inclusion Criteria:
Exclusion Criteria:
Germany | |
Heinrich-Heine-University, Div. of Cardiology, Pulmonary Disease and Vascular Medicine | |
Dusseldorf, NRW, Germany, 40225 |
Tracking Information | |||||
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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 |
Occurrence of thrombemboic events during 12 month [ Time Frame: 12 month ] | ||||
Original Primary Outcome Measures | Same as current | ||||
Change History | |||||
Current Secondary Outcome Measures |
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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. |
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Study Type | Observational | ||||
Study Design | Observational Model: Cohort Time Perspective: Prospective |
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Target Follow-Up Duration | Not Provided | ||||
Biospecimen | Retention: Samples Without DNA Description:
3ml venous blood
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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
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Study Groups/Cohorts |
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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. |
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Recruitment Information | |||||
Recruitment Status | Completed | ||||
Actual Enrollment |
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:
Exclusion Criteria:
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Sex/Gender |
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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 |
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IPD Sharing Statement |
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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 |