Cardiac InsufficiencyDAV-HémoNCT03306017
Effects of Left Ventricular Assist Device Implantation on the Phenotype of Blood Platelets and Leucocytes
A study testing Blood sampling in people with Cardiac Insufficiency, run by University Hospital, Toulouse at 1 site in France.
Trial summary
To compare in vivo platelet and leukocyte activation and phenotype before and after Left ventricular assist device (LAVD) implantation Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Cardiac Insufficiency
- What is being tested?
- Blood sampling
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteFrance
- Study dates
- 3 Oct 2017to 23 Jan 2019
- Phase
- Interventional
- 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
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- elective implantation of LAVD (Heartmate II),
- written informed consent to the study
- Patients with health insurance
Who cannot join
- treatment or procedure that could affect platelet functions or turn-over(low-dose aspirin is allowed).
- Pregnancy or breastfeeding
- Juridical Protection
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Study on the Effects of Left Ventricular Assist Device Implantation on the Phenotype of Blood Platelets and Leucocytes
To compare in vivo platelet and leukocyte activation and phenotype before and after Left ventricular assist device (LAVD) implantation
Read the detailed description
The present study plan to investigate platelet activation in vivo using a variety of biomarkers previously identified as sensitive to high shear stress in patients with severe aortic valve stenosis before and after trans arterial valve replacement. As one of the best biomarker is a high degree of platelet-leukocyte interactions, the study will study in parallel leukocytes activation/differentiation. These parameters will be compared at 3 time-points, before and after LAVD implantation in ambulatory patients.
- Conditions
- Cardiac Insufficiency
- Being tested
- Blood sampling
- Keywords
- left ventricular assist device, platelet-leukocyte conjugates, lipo-oxygenase products
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blood samplingOther
Three venous blood sampling before the left ventricular assist device implantation and 1 and 2 months after implantation in ambulatory patients.
| Study group | Role | What they receive |
|---|---|---|
| LAVD implantation | Experimental | Ten patients before and after LAVD implantation had blood sampling Receives: Other: Blood sampling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Platelet activation
To compare platelet activation in vivo, using a composite criteria determinated by variety of biomarkers of activation analysed by flow cytometry and enzyme-linked immunosorbent assay (ELISA)
Measured: Month 2 after LAVD implantation
Secondary outcomes (2)
Level of circulating platelet-leukocyte conjugate
To determine the level of circulating platelet-leukocyte conjugate by flow cytometry
Measured: Month 2 after LAVD implantation
Changes in leukocyte phenotype
To determine the leukocyte phenotype which is a composite criteria analysed by flow cytometry, ELISA and lipidaemic analysis
Measured: Month 2 after LAVD implantation
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Oct 2017
- Study start3 Oct 2017
- Primary completion23 Aug 2018
- Study completion23 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Cardiac InsufficiencyStudies of the same condition, open and under way.
- More trials run by University Hospital, ToulouseThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Toulouse
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Pierre SIE, MD, PhD, Study chair, University Hospital of Toulouse, Rangueil, Hematology laboratory
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03306017
- Sponsor's protocol ID
- RC31/16/8258
- Other IDs
- 2016-A01601-50
- Acronym
- DAV-Hémo
- Status last verified
- Aug 2019
- First submitted
- 24 Jul 2017
- Last updated
- 20 Aug 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Aug 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on the Effects of Left Ventricular Assist Device Implantation on the Phenotype of Blood Platelets and Leucocytes
- ClinicalTrials.gov ID
- NCT03306017
- Acronym / sponsor ID
- DAV-Hémo / RC31/16/8258
- Conditions
- Cardiac Insufficiency
- Keywords
- left ventricular assist device, platelet-leukocyte conjugates, lipo-oxygenase products
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 4 participants (actual)
- Lead sponsor
- University Hospital, ToulouseUniversity, hospital or other
- Study start
- 3 Oct 2017 (actual)
- Primary completion
- 23 Aug 2018 (actual)
- Study completion
- 23 Jan 2019 (actual)
- First posted
- 10 Oct 2017 (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.
To compare in vivo platelet and leukocyte activation and phenotype before and after Left ventricular assist device (LAVD) implantation
Detailed description
The present study plan to investigate platelet activation in vivo using a variety of biomarkers previously identified as sensitive to high shear stress in patients with severe aortic valve stenosis before and after trans arterial valve replacement. As one of the best biomarker is a high degree of platelet-leukocyte interactions, the study will study in parallel leukocytes activation/differentiation. These parameters will be compared at 3 time-points, before and after LAVD implantation in ambulatory patients.
Study design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| LAVD implantation | Experimental | Other: Blood samplingTen patients before and after LAVD implantation had blood sampling |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- elective implantation of LAVD (Heartmate II),
- written informed consent to the study
- Patients with health insurance
Key exclusion criteria (3 listed)
- treatment or procedure that could affect platelet functions or turn-over(low-dose aspirin is allowed).
- Pregnancy or breastfeeding
- Juridical Protection
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 samplingThree venous blood sampling before the left ventricular assist device implantation and 1 and 2 months after implantation in ambulatory patients. | Other | LAVD implantation |
Primary outcome
Platelet activation
Time frame: Month 2 after LAVD implantation
To compare platelet activation in vivo, using a composite criteria determinated by variety of biomarkers of activation analysed by flow cytometry and enzyme-linked immunosorbent assay (ELISA)
2 secondary outcomes
Level of circulating platelet-leukocyte conjugate
Time frame: Month 2 after LAVD implantation
Changes in leukocyte phenotype
Time frame: Month 2 after LAVD implantation
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 20 Aug 2019.
- Individual participant dataSharing planned: No
Related trials for Cardiac Insufficiency
RecruitingPhase 4
The Effects of Ferric Derisomaltose in Patients With Acute Heart Failure and Iron Deficiency on Exercise Capacity and Quality of Life(COREVIVE-HFrEF)
Heart Failure With Reduced Ejection Fraction, Iron Deficiency
Not yet recruitingPhase 2
A Study of Bimagrumab in Participants With HFpEF
Heart Failure, Diastolic, Diastolic Heart Failure
RecruitingObservational study
A Post-Market Assessment of the Safety and Performance of the TriClip™ System
Tricuspid Regurgitation (TR)
Recruiting
Evaluation of a French Hospital Discharge Therapeutic Education Program by Nurses for Heart Failure Patient (EduSor)
Heart Failure
Not yet recruiting
Smartphone Camera Measurement of Breathing-Related Heart Rate Variability Compared With ECG in Healthy Adults
Respiratory Sinus Arrhythmia, Heart Rate Variability
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.
Pierre SIE, MD, PhD study chair
University Hospital of Toulouse, Rangueil, Hematology laboratory
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Blood sampling in people with Cardiac Insufficiency, run by University Hospital, Toulouse at 1 site in France.
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 3 inclusion and 3 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 20 Aug 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 France. 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?
Platelet activation (time frame: Month 2 after LAVD implantation). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 20 Aug 2019.