Mitral Valve ProlapseMVP-FranceNCT00799565
Mitral Valve Prolapse (MVP) - France Study
A study testing catch of blood in people with Mitral Valve Prolapse, run by French Cardiology Society at 26 sites in France.
Trial summary
This prospective nation-wide (France) study aims to search for susceptibility genes in MVP using a genome wide analysis and comparing results obtained in 1000 patients with MVP and 1000 non-MVP subjects. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Mitral Valve Prolapse
- What is being tested?
- catch of blood
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 1,179 participants
- Where
- 26 sitesFrance
- Study dates
- Dec 2008to Jul 2011
- 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
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Male or female subject ≥18 years
- Affiliation to the French social insurance system
- Written informed consent
- Idiopathic MVP defined by the presence of criteria 1) and 2) OR of criterion 3) :
- Echographic MVP > 2 mm on the left ventricular parasternal long-axis view
- Echographic myxomatous valve (thickness > 4 mm) or significant mitral regurgitation (> 2 + using color Doppler)
Show all 10Show fewer
- History of mitral valve surgery for pure mitral regurgitation due to MVP (myxomatous or fibroelastic deficiency) with available detailed operative report.
- Male or female subject ≥40 years
- Absence of MVP or absence of mitral valve dystrophy
- Caucasian
Who cannot join
- Presence of heart disease causing MVP (rheumatic, HCM…)
- Syndromic disease (Marfan, Ehlers-Danlos…)
Trial locations and contacts
26 sites in 1 country.
26 sites in 1 country
France26 sites
Hôpital Sud
Amiens, 80054
Clinique Saint Augustin
Bordeaux, 33074
Hôpital Ambroise Paré
Boulogne, 92104
Hôpital de la Cavale Blanche
Brest, 29609
Hôpital Gabriel Montpied
Clermont-Ferrand, 63000
Hôpital Henri Mondor
Créteil, 94010
Hôpital du Bocage
Dijon, 21000
Hôpital Front-Pré
La Seyne-sur-Mer, 83000
Hôpital Cardiologique
Lille, 59037
Hôpital Dupuytren
Limoges, 87042
Groupement Hospitalier Est
Lyon, 69677
Hôpital de la Timone
Marseille, 13385
Institut Hospitalier Jacques Cartier
Massy, 91300
Hôpital Arnaud de Villeneuve
Montpellier, 34295
Hôpital G and R Laennec
Nantes, 44093
Hôpital Lariboisière
Paris, 75010
Hôpital Pitié Salpêtrière
Paris, 75013
Hôpital Européen Georges Pompidou
Paris, 75015
Hôpital Bichat
Paris, 75018
Hôpital Saint Antoine
Paris, 75571
Hôpital Cochin
Paris, 75679
Hôpital Cardiologique du Haut Lévêque
Pessac, 33604
Hôpital Pontchaillou
Rennes, 35033
Hôpital Charles Nicolle
Rouen, 76000
Hôpital Rangueil
Toulouse, 31059
CHU Nancy
Vandœuvre-lès-Nancy, 54500
About this study
Official title: Genetic Polymorphisms in Idiopathic Mitral Valve Prolapse :A French Prospective Study Using a Genome Wide Analysis
This prospective nation-wide (France) study aims to search for susceptibility genes in MVP using a genome wide analysis and comparing results obtained in 1000 patients with MVP and 1000 non-MVP subjects.
Read the detailed description
Two MVP populations will be defined in that study, either with the classical Barlow (myxomatous) disease or the fibroelastic degenerescence (thin and redundant leaflets).
MVP adult patients (> 18 year-old) will be included if they present the following 1) or 2) criteria :
- 2D-echocardiographic mitral leaflet prolapse on the parasternal long-axis view > 2 mm AND leaflet thickness > 4 mm or mitral regurgitation > 2 + (using color Doppler)
- Previous surgery for pure severe mitral regurgitation due to MVP with Barlow disease or fibroelastic degenerescence (with operative report available)
Patients will be excluded in case of associated heart disease (hypertrophic cardiomyopathy, rheumatismal disease…) or syndromic disease (Marfan, Ehlers-Danlos…).
Around 30 (cardiology, cardiovascular surgery) french centers will participate to this study. An e-CRF will be used to collect clinical data. A genetic core lab will collect the DNA samples. An echocardiographic core lab will collect and read all the echo recordings.
DNA analysis will be compared between the patient group and spouses of the patients used as controls. In case of inadequacies concerning group size or age, available genotyped cohorts will be used.
- Conditions
- Mitral Valve Prolapse
- Being tested
- catch of blood
- Keywords
- Mitral Valve prolapse, echography, genetic study, study case-witness, Patients with a Mitral Valve Prolapse
- Medical subject headings
- Mitral Valve Prolapse
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
catch of bloodGenetic
4 tubes of blood are taken on subjects. Samples are sent in Pr Jeunemaître to extract DNA and stock it.
This DNA bank aims to search for susceptibility genes in MVP using a genome wide analysis and comparing results obtained in 1000 patients with MVP and 1000 non-MVP subjects
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Subject with a Mitral Valvular Prolapse Receives: Genetic: catch of blood |
| 2 | Experimental | Healthy Volunteers Receives: Genetic: catch of blood |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genetic polymorphism identification
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Dec 2008 (estimated)
- Study startDec 2008
- Primary completionJul 2011
- Study completionJul 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Mitral Valve ProlapseStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 1,179 participants (actual)
Sponsor and investigators
- Lead sponsor
- French Cardiology Society
- Sponsor type
- University, hospital or other
- Collaborators
- Leducq Foundation, Institut National de la Santé Et de la Recherche Médicale, France, Centre National de Génotypage
- Investigators
- Albert Alain Hagège, MD, PhD, Principal investigator, Hôpital Européen Georges-Pompidou
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00799565
- Sponsor's protocol ID
- 2008-01
- Acronym
- MVP-France
- Status last verified
- Jul 2011
- First submitted
- 24 Nov 2008
- Last updated
- 14 Jul 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 14 Jul 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Polymorphisms in Idiopathic Mitral Valve Prolapse :A French Prospective Study Using a Genome Wide Analysis
- ClinicalTrials.gov ID
- NCT00799565
- Acronym / sponsor ID
- MVP-France / 2008-01
- Conditions
- Mitral Valve Prolapse
- Keywords
- Mitral Valve prolapse, echography, genetic study, study case-witness, Patients with a Mitral Valve Prolapse
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 1,179 participants (actual)
- Lead sponsor
- French Cardiology SocietyUniversity, hospital or other
- Collaborators
- Leducq Foundation, Institut National de la Santé Et de la Recherche Médicale, France, Centre National de Génotypage
- Study start
- Dec 2008
- Primary completion
- Jul 2011 (actual)
- Study completion
- Jul 2011 (actual)
- First posted
- 1 Dec 2008 (estimated)
- 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.
This prospective nation-wide (France) study aims to search for susceptibility genes in MVP using a genome wide analysis and comparing results obtained in 1000 patients with MVP and 1000 non-MVP subjects.
Detailed description
Two MVP populations will be defined in that study, either with the classical Barlow (myxomatous) disease or the fibroelastic degenerescence (thin and redundant leaflets).
MVP adult patients (> 18 year-old) will be included if they present the following 1) or 2) criteria :
- 2D-echocardiographic mitral leaflet prolapse on the parasternal long-axis view > 2 mm AND leaflet thickness > 4 mm or mitral regurgitation > 2 + (using color Doppler)
- Previous surgery for pure severe mitral regurgitation due to MVP with Barlow disease or fibroelastic degenerescence (with operative report available)
Patients will be excluded in case of associated heart disease (hypertrophic cardiomyopathy, rheumatismal disease…) or syndromic disease (Marfan, Ehlers-Danlos…).
Around 30 (cardiology, cardiovascular surgery) french centers will participate to this study. An e-CRF will be used to collect clinical data. A genetic core lab will collect the DNA samples. An echocardiographic core lab will collect and read all the echo recordings.
DNA analysis will be compared between the patient group and spouses of the patients used as controls. In case of inadequacies concerning group size or age, available genotyped cohorts will be used.
Study design
- Primary purpose
- Screening
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | Experimental | Genetic: catch of bloodSubject with a Mitral Valvular Prolapse |
| 2 | Experimental | Genetic: catch of bloodHealthy Volunteers |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Male or female subject ≥18 years
- Affiliation to the French social insurance system
- Written informed consent
- Idiopathic MVP defined by the presence of criteria 1) and 2) OR of criterion 3) :
- Male or female subject ≥40 years
Key exclusion criteria (2 listed)
- Presence of heart disease causing MVP (rheumatic, HCM…)
- Syndromic disease (Marfan, Ehlers-Danlos…)
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 |
|---|---|---|
| catch of blood4 tubes of blood are taken on subjects. Samples are sent in Pr Jeunemaître to extract DNA and stock it. This DNA bank aims to search for susceptibility genes in MVP using a genome wide analysis and comparing results obtained in 1000 patients with MVP and 1000 non-MVP subjects | Genetic | 1, 2 |
Primary outcome
Genetic polymorphism identification
Time frame: Day 1
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 14 Jul 2011.
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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.
Albert Alain Hagège, MD, PhD principal investigator
Hôpital Européen Georges-Pompidou
26 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing catch of blood in people with Mitral Valve Prolapse, run by French Cardiology Society at 26 sites 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 10 inclusion and 2 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 14 Jul 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 26 sites 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?
Genetic polymorphism identification (time frame: Day 1). 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 Jul 2011.