Aortic Valve Regurgitation AcquiredNCT03279029
Aortic Valve Regurgitation Acquired After Left Ventricular Assist Device Implantation: an Outstanding in Vivo Model of Valvular Heart Diseases
A study testing blood samples and biopsy in people with Aortic Valve Regurgitation Acquired, run by Assistance Publique Hopitaux De Marseille at 1 site in France.
Trial summary
To investigate histological structure and molecular changes involved on the onset of AVD after left ventricular assist device (LVAD) implantation and to compare them with those of patients operated on for severe aortic regurgitation. Methods: Bridge-to-transplant patients with AVD post-LVAD implantation are included. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Aortic Valve Regurgitation Acquired
- What is being tested?
- blood samples and biopsy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteFrance
- Study dates
- 14 Sep 2017to 8 Aug 2023
- 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
- Patients with long-term left-ventricular assistance awaiting transplant
- Patients with severe aortic surgical spring deficiency
- Major Patient
Who cannot join
- Minor Patient
- Pregnant or nursing women
- Major under guardianship
- People in emergencies
- Persons not covered by the social security scheme
Trial locations and contacts
1 site in 1 country.
About this study
To investigate histological structure and molecular changes involved on the onset of AVD after left ventricular assist device (LVAD) implantation and to compare them with those of patients operated on for severe aortic regurgitation.
Methods: Bridge-to-transplant patients with AVD post-LVAD implantation are included. Patients operated on for severe aortic regurgitation are included as control. Clinical and TTE data are compiled. Samples of aortic valve are collected at the time of the intervention. RNA-sequencing analysis is performed in LVAD patients and variations of gene expression are validated by real time qPCR in both. Blood sampling are performed pre-operatively and at one-month follow up to assess the plasma level of previously identified gene modulators. In-vitro studies exposing VICs and VECs to several mechanical stimuli are performed for validation.
Conclusion(s) Taking together, the in-vivo and in-vitro models would provide important information for the understanding of valve remodeling and disease. ECM gene modulators could represent pertinent molecular targets to stop the progression of AVD
- Conditions
- Aortic Valve Regurgitation Acquired
- Being tested
- blood samples, biopsy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
blood samplesBiological
blood samples
biopsyBiological
biopsy of aortic valve
| Study group | Role | What they receive |
|---|---|---|
| patients with aortic valve disease (AVD). | Experimental | Not described Receives: Biological: blood samples; Biological: biopsy |
| patients with left ventricular assist device (LVAD | Experimental | Not described Receives: Biological: blood samples; Biological: biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
blood sample
RNA-sequencing analysis
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Sep 2017
- Study start14 Sep 2017
- Primary completion14 Sep 2018
- Study completion8 Aug 2023 (estimated)
Why it stopped: 2 patients included only
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Aortic Valve Regurgitation AcquiredStudies of the same condition, open and under way.
- More trials run by Assistance Publique Hopitaux De MarseilleThe 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
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique Hopitaux De Marseille
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- alexis THERON, Principal investigator, Assistance Publique Hopitaux De Marseille
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03279029
- Sponsor's protocol ID
- 2017-08
- Other IDs
- 2017-A00680-53
- Status last verified
- Aug 2023
- First submitted
- 8 Sep 2017
- Last updated
- 14 Aug 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Aortic Valve Regurgitation Acquired After Left Ventricular Assist Device Implantation: an Outstanding in Vivo Model of Valvular Heart Diseases
- ClinicalTrials.gov ID
- NCT03279029
- Acronym / sponsor ID
- 2017-08
- Conditions
- Aortic Valve Regurgitation Acquired
- Study type
- Interventional
- Recruitment status
- SuspendedReason stopped: 2 patients included only
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Assistance Publique Hopitaux De MarseilleUniversity, hospital or other
- Study start
- 14 Sep 2017 (actual)
- Primary completion
- 14 Sep 2018 (actual)
- Study completion
- 8 Aug 2023 (estimated)
- First posted
- 12 Sep 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 investigate histological structure and molecular changes involved on the onset of AVD after left ventricular assist device (LVAD) implantation and to compare them with those of patients operated on for severe aortic regurgitation.
Methods: Bridge-to-transplant patients with AVD post-LVAD implantation are included. Patients operated on for severe aortic regurgitation are included as control. Clinical and TTE data are compiled. Samples of aortic valve are collected at the time of the intervention. RNA-sequencing analysis is performed in LVAD patients and variations of gene expression are validated by real time qPCR in both. Blood sampling are performed pre-operatively and at one-month follow up to assess the plasma level of previously identified gene modulators. In-vitro studies exposing VICs and VECs to several mechanical stimuli are performed for validation.
Conclusion(s) Taking together, the in-vivo and in-vitro models would provide important information for the understanding of valve remodeling and disease. ECM gene modulators could represent pertinent molecular targets to stop the progression of AVD
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| patients with aortic valve disease (AVD). | Experimental | Biological: blood samples, Biological: biopsy |
| patients with left ventricular assist device (LVAD | Experimental | Biological: blood samples, Biological: biopsy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with long-term left-ventricular assistance awaiting transplant
- Patients with severe aortic surgical spring deficiency
- Major Patient
Key exclusion criteria (5 listed)
- Minor Patient
- Pregnant or nursing women
- Major under guardianship
- People in emergencies
- Persons not covered by the social security scheme
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 | Biological | patients with aortic valve disease (AVD)., patients with left ventricular assist device (LVAD |
| biopsybiopsy of aortic valve | Biological | patients with aortic valve disease (AVD)., patients with left ventricular assist device (LVAD |
Primary outcome
blood sample
Time frame: 24 months
RNA-sequencing analysis
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Aug 2023.
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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.
alexis THERON principal investigator
Assistance Publique Hopitaux De Marseille
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 samples and biopsy in people with Aortic Valve Regurgitation Acquired, run by Assistance Publique Hopitaux De Marseille 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 5 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: paused, as of the sponsor's last update on 14 Aug 2023. 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?
Results are not available in the source record.
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?
blood sample (time frame: 24 months). 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 14 Aug 2023.