Mitral Valve ProlapseMVPNCT03884426
Genetic and Phenotypic Characteristics of Mitral Valve Prolapse
An observational study of Mitral Valve Prolapse and Genetic Disease, run by Nantes University Hospital at 3 sites in France.
Trial summary
Phenotypic characterisation of MVP by echocardiography in families. Identification of genes involved in MVP. Read more about this study
- Who is it for?
- Any ageHealthy volunteers can take part
- Conditions the study is for
- Mitral Valve Prolapse, Genetic Disease
- How many people
- 1,000 participants
- Where
- 3 sitesFrance
- Study dates
- Dec 2010to Dec 2021
- 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 Any age
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
Study population: Patients of both sex of any age with typical mitral valve prolapse and relatives examined during familial screening
Who may be able to join
- Patients of any age
- with typical mitral valve prolapse
- relatives examined during familial screening
Who cannot join
- Refusal of the patient
Trial locations and contacts
3 sites in 1 country.
France3 sites, 3 recruiting
- Not yet recruiting
Brest University Hospital
Brest, 29200
Jacques Mansourati, PU-PH, 02 98 34 73 91, jacques.mansourati@chu-brest.fr
Yves Etienne, PH
- Recruiting
Nantes University Hospital
Nantes, 44093
Thierry Le Tourneau, PU-PH, 0617908670, thletourneau@yahoo.fr
Thierry Le Tourneau, PU-PH
- Recruiting
Rennes University Hospital
Rennes, 35033
Erwan Donal, PU-PH, 02 99 28 25 27, erwan.donal@chu-rennes.fr
Erwan Donal, PU-PH
About this study
Phenotypic characterisation of MVP by echocardiography in families. Identification of genes involved in MVP.
Read the detailed description
After clinical identification of patients with MVP, doctors organize 1st degree relative familial screening. A comprehensive echocardiography was carried out along with clinical examination. All echo data were stored for off-line analysis by a sonographer in our Core-lab. Blood was sample at the time of echocardiography in adult patients for DNA analyses. Follow-up for mitral valve changes will be performed after 5 years.
- Conditions
- Mitral Valve Prolapse, Genetic Disease
- Keywords
- Mitral valve prolapse, genetic, echocardiography
- Medical subject headings
- Mitral Valve Prolapse, Genetic Diseases, Inborn
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients with MVP | The patients concerned are patients with known or recently discovered Barlow-type mitral prolapse, whatever the degree of severity. | |
| Normal relatives | Related healthy patients, for an average of 6 individuals per family |
What is being measured
The primary outcome is the main question the study is designed to answer.
MVP defined by a superior displacement of at least 2 mm
MVP defined by a superior displacement of at least 2 mm
Measured: At Day 0
Secondary outcomes (4)
Comprehensive mitral valve apparatus characterization per size of items (leaflets, chordae, annulus)
Leaflets length ; Chordae length ; Annulus diameter
Measured: At Day 0
Comprehensive mitral valve apparatus characterization per other items (papillary muscle, ventricles)
Papillary muscles aspect ; Right Ventricle function ; Left Ventricle Ejection Fraction
Measured: At Day 0
Comprehensive mitral valve apparatus characterization per size of items (ventricle and atrium sizes)
Left ventricle and atrium sizes ; right ventricle size ; right Atrium size
Measured: At Day 0
Comprehensive mitral valve apparatus characterization per size of items
Leaflets thickness
Measured: At Day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2019
- Study startDec 2010
- Primary completionDec 2021 (estimated)
- Study completionDec 2021 (estimated)
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 Mitral Valve ProlapseStudies of the same condition, open and under way.
- More trials run by Nantes University HospitalThe 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
- Observational
- Observational model
- Family based
- Time perspective
- Prospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nantes University Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- University Hospital, Brest, Rennes University Hospital
- Responsible party
- Sponsor
- Investigators
- Vincent Probst, PU-PH, Principal investigator, Nantes University HospitalHervé Le Marec, PU-PH, Principal investigator, Nantes University HospitalJean-Jacques Schott, DR, Principal investigator, Institut National de la Santé Et de la Recherche Médicale, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03884426
- Sponsor's protocol ID
- RC12_0143
- Acronym
- MVP
- Status last verified
- Aug 2021
- First submitted
- 21 Mar 2013
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
Publications
Huttin O, Girerd N, Jobbe-Duval A, Constant Dit Beaufils AL, Senage T, Filippetti L, Cueff C, Duarte K, Fraix A, Piriou N, Mandry D, Pace N, Le Scouarnec S, Capoulade R, Echivard M, Sellal JM, Marrec M, Beaumont M, Hossu G, Trochu JN, Sadoul N, Marie PY, Guenancia C, Schott JJ, Roussel JC, Serfaty JM, Selton-Suty C, Le Tourneau T. Machine Learning-Based Phenogrouping in MVP Identifies Profiles Associated With Myocardial Fibrosis and Cardiovascular Events. JACC Cardiovasc Imaging. 2023 Oct;16(10):1271-1284. doi: 10.1016/j.jcmg.2023.03.009. Epub 2023 May 17.
PubMed 37204382
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic and Phenotypic Characteristics of Mitral Valve Prolapse
- ClinicalTrials.gov ID
- NCT03884426
- Acronym / sponsor ID
- MVP / RC12_0143
- Conditions
- Mitral Valve Prolapse, Genetic Disease
- Keywords
- Mitral valve prolapse, genetic, echocardiography
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Nantes University HospitalUniversity, hospital or other
- Collaborators
- University Hospital, Brest, Rennes University Hospital
- Study start
- Dec 2010 (actual)
- Primary completion
- Dec 2021 (estimated)
- Study completion
- Dec 2021 (estimated)
- First posted
- 21 Mar 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.
Phenotypic characterisation of MVP by echocardiography in families. Identification of genes involved in MVP.
Detailed description
After clinical identification of patients with MVP, doctors organize 1st degree relative familial screening. A comprehensive echocardiography was carried out along with clinical examination. All echo data were stored for off-line analysis by a sonographer in our Core-lab. Blood was sample at the time of echocardiography in adult patients for DNA analyses. Follow-up for mitral valve changes will be performed after 5 years.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients with MVP | – | –The patients concerned are patients with known or recently discovered Barlow-type mitral prolapse, whatever the degree of severity. |
| Normal relatives | – | –Related healthy patients, for an average of 6 individuals per family |
Who may qualify
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Patients of both sex of any age with typical mitral valve prolapse and relatives examined during familial screening
Key inclusion criteria (3 listed)
- Patients of any age
- with typical mitral valve prolapse
- relatives examined during familial screening
Key exclusion criteria (1 listed)
- Refusal of the patient
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
MVP defined by a superior displacement of at least 2 mm
Time frame: At Day 0
MVP defined by a superior displacement of at least 2 mm
4 secondary outcomes
Comprehensive mitral valve apparatus characterization per size of items (leaflets, chordae, annulus)
Time frame: At Day 0
Comprehensive mitral valve apparatus characterization per other items (papillary muscle, ventricles)
Time frame: At Day 0
Comprehensive mitral valve apparatus characterization per size of items (ventricle and atrium sizes)
Time frame: At Day 0
Comprehensive mitral valve apparatus characterization per size of items
Time frame: At Day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- Derived from this study: PubMed 37204382Huttin O, Girerd N, Jobbe-Duval A, Constant Dit Beaufils AL, Senage T, Filippetti L, Cueff C, Duarte K, Fraix A, Piriou N, Mandry D, Pace N, Le Scouarnec S, Capoulade R, Echivard M, Sellal JM, Marrec M, Beaumont M, Hossu G, Trochu JN, Sadoul N, Marie PY, Guenancia C, Schott JJ, Roussel JC, Serfaty JM, Selton-Suty C, Le Tourneau T. Machine Learning-Based Phenogrouping in MVP Identifies Profiles Associated With Myocardial Fibrosis and Cardiovascular Events. JACC Cardiovasc Imaging. 2023 Oct;16(10):1271-1284. doi: 10.1016/j.jcmg.2023.03.009. Epub 2023 May 17.
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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.
Vincent Probst, PU-PH principal investigator
Nantes University Hospital
Hervé Le Marec, PU-PH principal investigator
Nantes University Hospital
Jean-Jacques Schott, DR principal investigator
Institut National de la Santé Et de la Recherche Médicale, France
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Mitral Valve Prolapse and Genetic Disease, run by Nantes University Hospital at 3 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 3 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: status not confirmed, as of the sponsor's last update on 30 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Thierry Le Tourneau, PU-PH (0617908670, thletourneau@yahoo.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
MVP defined by a superior displacement of at least 2 mm (time frame: At Day 0). 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 NCT03884426, 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 30 Aug 2021.