End Stage Heart FailureMP-LVADNCT03923413
Endothelial Function and Circulating Microparticle in Patients Under LVAD Support
An observational study of End Stage Heart Failure, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Heart Failure
- What is being tested?
- Blood samples
- How many people
- 65 participants
- Where
- 1 siteGermany
- Study dates
- 1 May 2017to 31 May 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Adult, Older adult
Study population: Patients in the heart failure program of the University of Duesseldorf
Who may be able to join
- Inclusion Criteria: chronic heart failure INTERMASC 5-7 or
- Patients on LVAD support
Who cannot join
- current thrombembolic or bleeding event
Trial locations and contacts
1 site in 1 country.
Germany1 site
Heinrich-Heine-University, Div. of Cardiology, Pulmonary Disease and Vascular Medicine
Düsseldorf, North Rhine-Westphalia, 40225
About this study
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.
Read the 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
- Being tested
- Blood samples
- Keywords
- circulating MP, FMD, LVAD, endothelial function, endothelial integrity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplesOther
Blood samples for MP evaluation
| Study group | Role | What they receive |
|---|---|---|
| patients with chronic heart failure without LVAD support | patients with chronic heart failure without LVAD support Receives: Other: Blood samples | |
| patients with end-stage heart failure with LVAD support | patients with end-stage heart failure with LVAD support Receives: Other: Blood samples |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of thrombemboic events during 12 month
Measured: 12 month
Secondary outcomes (3)
Endothelial function
Flow mediated dilatation measured by ultrasound
Measured: Baseline
Level of circulating mircoparticles
measured and discriminated by FACS and ELISA
Measured: Baseline
microparticle induced thrombin generation
measured and discriminated by FACS and ELISA
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Apr 2019
- Study start1 May 2017
- Primary completion31 May 2019
- Study completion31 May 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for End Stage Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heinrich-Heine University, Duesseldorf
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Klinik für Kardiologie, Pneumologie und Angiologie, Heinrich-Heine University, Duesseldorf
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03923413
- Sponsor's protocol ID
- 14-018
- Acronym
- MP-LVAD
- Status last verified
- Jun 2019
- First submitted
- 12 Apr 2019
- Last updated
- 21 Jun 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
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.
PubMed 33346991
Study at a glance
From the registry record, last updated by the sponsor on 21 Jun 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endothelial Function and Circulating Microparticle in Patients Under LVAD Support
- ClinicalTrials.gov ID
- NCT03923413
- Acronym / sponsor ID
- MP-LVAD / 14-018
- Conditions
- End Stage Heart Failure
- Keywords
- circulating MP, FMD, LVAD, endothelial function, endothelial integrity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Heinrich-Heine University, DuesseldorfUniversity, hospital or other
- Study start
- 1 May 2017 (actual)
- Primary completion
- 31 May 2019 (actual)
- Study completion
- 31 May 2019 (actual)
- First posted
- 22 Apr 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with chronic heart failure without LVAD support | – | Other: Blood samplespatients with chronic heart failure without LVAD support |
| patients with end-stage heart failure with LVAD support | – | Other: Blood samplespatients with end-stage heart failure with LVAD support |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Patients in the heart failure program of the University of Duesseldorf
Key inclusion criteria (2 listed)
- Inclusion Criteria: chronic heart failure INTERMASC 5-7 or
- Patients on LVAD support
Key exclusion criteria (1 listed)
- current thrombembolic or bleeding event
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blood samplesBlood samples for MP evaluation | Other | patients with chronic heart failure without LVAD support, patients with end-stage heart failure with LVAD support |
Primary outcome
Occurrence of thrombemboic events during 12 month
Time frame: 12 month
3 secondary outcomes
Endothelial function
Time frame: Baseline
Level of circulating mircoparticles
Time frame: Baseline
microparticle induced thrombin generation
Time frame: Baseline
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Jun 2019.
- Derived from this study: PubMed 33346991Kramser 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.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of End Stage Heart Failure, run by Heinrich-Heine University, Duesseldorf at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 Jun 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of thrombemboic events during 12 month (time frame: 12 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03923413, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Jun 2019.