Mitral Valve ProlapseSTAMP-2NCT04852731
STretch and Myocardial Characterization in Arrythmogenic Mitral Valve Prolapse-2
A study testing Cardiac MRI, Blood collection and Prolongation of the MRI examination in people with Mitral Valve Prolapse, run by Central Hospital, Nancy, France at 1 site in France.
Trial summary
Mitral valve prolapse (MVP) is a frequent affection of the mitral valve with a prevalence of 2-3% in the general population. This valvular disease is generally considered as benign, but may at term evolve toward mitral valve regurgitation of various severity and/or arrhythmia. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mitral Valve Prolapse
- What is being tested?
- Cardiac MRI, Blood collection and Prolongation of the MRI examination
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 280 participants
- Where
- 1 siteFrance
- Study dates
- 30 Aug 2021to 29 Nov 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- Patient over 18 years old,
- Patient with mitral valve prolapse,
- Patient who has received full information about the organization of the research and has signed an informed consent,
- Patient affiliated to or beneficiary of a social security insurance,
- Patient who has completed a prior clinical examination adapted to the research and who does not show any contraindication to the planned examinations
Who cannot join
- Stage of the disease: Patients with MVP with severe mitral regurgitation with a surgical indication as defined by current recommendations will not be included in the study,
- Presence of severe rhythm disorders requiring the implantation of a defibrillator (cardiorespiratory arrest recovered, sudden death recovered, etc.),
- Performance of an injected MRI in the month preceding the MRI scheduled during visit n°1,
- Previously diagnosed cardiopathy that may be responsible for myocardial damage (ventricular remodeling, alteration of left ventricular systolic function, fibrosis, etc.) and that may disrupt the interpretation of results (infarction, amyloidosis, systemic scleroderma, significant aortic valvulopathy, etc.).
- Contraindication to MRI examination, particularly in the presence of an implantable pacemaker or defibrillator, implanted pump, cochlear implants, neurosurgical clips, intraorbital or encephalic metallic foreign bodies,
- Claustrophobia or morphotype that does not allow MRI to be performed,
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- Motor or mental disability,
- Renal impairment that does not allow the injection of Gadolinium-based contrast media (DOTAREM® or equivalent in the study). If there is any doubt as to the patient's renal function, a plasma creatinine determination will be performed for MRI to ensure the absence of renal failure,
- Hypersensitivity to gadoteric acid, meglumine, or any gadolinium-containing drug.
- Women of childbearing age who do not have effective contraception,
- Persons referred to in Articles L. 1121-5 to L1121-8 of the Public Health Code.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Dynamic Evaluation of Myocardial Fibrosis and Structural Determinants of Ventricular Arrhythmia in Mitral Valve Prolapse (STAMP-2 : STretch and Myocardial Characterization in Arrythmogenic Mitral Valve Prolapse-2)
Mitral valve prolapse (MVP) is a frequent affection of the mitral valve with a prevalence of 2-3% in the general population. This valvular disease is generally considered as benign, but may at term evolve toward mitral valve regurgitation of various severity and/or arrhythmia.
Mitral valve prolapse is routinely diagnosed using transthoracic echocardiography. Subsequent examinations (24-hour external loop recording, exercise electrocardiogram, cardiac Magnetic Resonance Imaging) and a close follow-up can be proposed to the patient depending on its condition.
Read more
More recently, detection of myocardial fibrosis and a mitral ring disjunction among patients with MVP were associated with the occurrence of severe ventricular arrhythmia.
The investigators hypothesize that ventricular remodeling over time is mediated by the progression of mitral insufficiency severity from myocardial fibrosis secondary to MVP and possibly promoted by other mitral valve abnormalities. This remodeling, characterized by circulating biomarkers and imaging (MRI and echocardiography), could allow the identification of patients with a higher risk of severe ventricular arrhythmia.
The main objective of this study is to identify prognostic factors for unfavorable evolution (ventricular remodeling or a rhythm disorder event) at 3 years from initial assessments in MVP patients.
- Conditions
- Mitral Valve Prolapse
- Being tested
- Cardiac MRI, Blood collection, Prolongation of the MRI examination
- 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.
Cardiac MRIProcedure or surgery
Injected cardiac MRI
Blood collectionOther
Blood collection (including genetics at the inclusion visit)
Prolongation of the MRI examinationProcedure or surgery
Prolongation of the MRI examination (4D flow sequence ; about 10 min)
| Study group | Role | What they receive |
|---|---|---|
| Group A (a) : patients without mitral regurgitation without ventricular extrasystole (≤10/hour) | Experimental | These patients will undergo at the inclusion and 36 months after the inclusion :
* According to recommendations : echocardiography, 24-hour external loop recording and exercise ECG,
* And specifically for research purposes : injected cardiac MRI and a blood collection. Receives: Procedure: Cardiac MRI; Other: Blood collection |
| Group A (b) : patients without mitral regurgitation with ventricular extrasystole (>10/hour) | Experimental | These patients will undergo at the inclusion and 36 months after the inclusion :
* According to recommendations : echocardiography, 24-hour external loop recording, exercise ECG, injected cardiac MRI,
* And specifically for research purposes : prolongation of the MRI examination (4D flow sequence) and a blood collection. Receives: Other: Blood collection; Procedure: Prolongation of the MRI examination |
| Group B : patients with Mitral valve prolapse with trivial mitral regurgitation | Experimental | These patients will undergo at the inclusion and 36 months after the inclusion :
* According to recommendations : echocardiography, 24-hour external loop recording, exercise ECG, injected cardiac MRI,
* And specifically for research purposes : prolongation of the MRI examination (4D flow sequence) and a blood collection. Receives: Other: Blood collection; Procedure: Prolongation of the MRI examination |
| Group C : patients with Mitral valve prolapse with moderate or mild mitral regurgitation | Experimental | These patients will undergo at the inclusion and 36 months after the inclusion :
* According to recommendations : echocardiography, 24-hour external loop recording, exercise ECG, injected cardiac MRI,
* And specifically for research purposes : prolongation of the MRI examination (4D flow sequence) and a blood collection. Receives: Other: Blood collection; Procedure: Prolongation of the MRI examination |
| Group D : patients with asymptomatic Mitral valve prolapse with severe mitral regurgitation | Experimental | These patients will undergo at the inclusion and 36 months after the inclusion :
* According to recommendations : echocardiography, 24-hour external loop recording, exercise ECG, injected cardiac MRI,
* And specifically for research purposes : prolongation of the MRI examination (4D flow sequence) and a blood collection. Receives: Other: Blood collection; Procedure: Prolongation of the MRI examination |
What is being measured
The primary outcome is the main question the study is designed to answer.
Presence of ventricular remodelling
Variation of at least 10% of the telestolic volume observed at 3 years on cardiac MRI compared to the initial cardiac MRI
Measured: 3 years
Presence of ventricular arrythmia (fibrillation or tachycardia, extrasystoles)
Occurrence of any ventricular arrythmia on external loop recording or exercise ECG
Measured: 3 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Apr 2021
- Study start30 Aug 2021
- Primary completion29 Nov 2027 (estimated)
- Study completion29 Nov 2027 (estimated)
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.
- More trials run by Central Hospital, Nancy, FranceThe 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
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Jean-Marc SELLAL, Central Hospital, Nancy, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04852731
- Sponsor's protocol ID
- 2020-A02680-39
- Acronym
- STAMP-2
- Status last verified
- Jun 2026
- First submitted
- 16 Apr 2021
- Last updated
- 18 Jun 2026
- 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 18 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Dynamic Evaluation of Myocardial Fibrosis and Structural Determinants of Ventricular Arrhythmia in Mitral Valve Prolapse (STAMP-2 : STretch and Myocardial Characterization in Arrythmogenic Mitral Valve Prolapse-2)
- ClinicalTrials.gov ID
- NCT04852731
- Acronym / sponsor ID
- STAMP-2 / 2020-A02680-39
- Conditions
- Mitral Valve Prolapse
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 30 Aug 2021 (actual)
- Primary completion
- 29 Nov 2027 (estimated)
- Study completion
- 29 Nov 2027 (estimated)
- First posted
- 21 Apr 2021 (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.
Mitral valve prolapse (MVP) is a frequent affection of the mitral valve with a prevalence of 2-3% in the general population. This valvular disease is generally considered as benign, but may at term evolve toward mitral valve regurgitation of various severity and/or arrhythmia.
Mitral valve prolapse is routinely diagnosed using transthoracic echocardiography. Subsequent examinations (24-hour external loop recording, exercise electrocardiogram, cardiac Magnetic Resonance Imaging) and a close follow-up can be proposed to the patient depending on its condition.
More recently, detection of myocardial fibrosis and a mitral ring disjunction among patients with MVP were associated with the occurrence of severe ventricular arrhythmia.
The investigators hypothesize that ventricular remodeling over time is mediated by the progression of mitral insufficiency severity from myocardial fibrosis secondary to MVP and possibly promoted by other mitral valve abnormalities. This remodeling, characterized by circulating biomarkers and imaging (MRI and echocardiography), could allow the identification of patients with a higher risk of severe ventricular arrhythmia.
The main objective of this study is to identify prognostic factors for unfavorable evolution (ventricular remodeling or a rhythm disorder event) at 3 years from initial assessments in MVP patients.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Group A (a) : patients without mitral regurgitation without ventricular extrasystole (≤10/hour) | Experimental | Procedure: Cardiac MRI, Other: Blood collectionThese patients will undergo at the inclusion and 36 months after the inclusion : * According to recommendations : echocardiography, 24-hour external loop recording and exercise ECG, * And specifically for research purposes : injected cardiac MRI and a blood collection. |
| Group A (b) : patients without mitral regurgitation with ventricular extrasystole (>10/hour) | Experimental | Other: Blood collection, Procedure: Prolongation of the MRI examinationThese patients will undergo at the inclusion and 36 months after the inclusion : * According to recommendations : echocardiography, 24-hour external loop recording, exercise ECG, injected cardiac MRI, * And specifically for research purposes : prolongation of the MRI examination (4D flow sequence) and a blood collection. |
| Group B : patients with Mitral valve prolapse with trivial mitral regurgitation | Experimental | Other: Blood collection, Procedure: Prolongation of the MRI examinationThese patients will undergo at the inclusion and 36 months after the inclusion : * According to recommendations : echocardiography, 24-hour external loop recording, exercise ECG, injected cardiac MRI, * And specifically for research purposes : prolongation of the MRI examination (4D flow sequence) and a blood collection. |
| Group C : patients with Mitral valve prolapse with moderate or mild mitral regurgitation | Experimental | Other: Blood collection, Procedure: Prolongation of the MRI examinationThese patients will undergo at the inclusion and 36 months after the inclusion : * According to recommendations : echocardiography, 24-hour external loop recording, exercise ECG, injected cardiac MRI, * And specifically for research purposes : prolongation of the MRI examination (4D flow sequence) and a blood collection. |
| Group D : patients with asymptomatic Mitral valve prolapse with severe mitral regurgitation | Experimental | Other: Blood collection, Procedure: Prolongation of the MRI examinationThese patients will undergo at the inclusion and 36 months after the inclusion : * According to recommendations : echocardiography, 24-hour external loop recording, exercise ECG, injected cardiac MRI, * And specifically for research purposes : prolongation of the MRI examination (4D flow sequence) and a blood collection. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Patient over 18 years old,
- Patient with mitral valve prolapse,
- Patient who has received full information about the organization of the research and has signed an informed consent,
- Patient affiliated to or beneficiary of a social security insurance,
- Patient who has completed a prior clinical examination adapted to the research and who does not show any contraindication to the planned examinations
Key exclusion criteria (11 listed)
- Stage of the disease: Patients with MVP with severe mitral regurgitation with a surgical indication as defined by current recommendations will not be included in the study,
- Presence of severe rhythm disorders requiring the implantation of a defibrillator (cardiorespiratory arrest recovered, sudden death recovered, etc.),
- Performance of an injected MRI in the month preceding the MRI scheduled during visit n°1,
- Previously diagnosed cardiopathy that may be responsible for myocardial damage (ventricular remodeling, alteration of left ventricular systolic function, fibrosis, etc.) and that may disrupt the interpretation of results (infarction, amyloidosis, systemic scleroderma, significant aortic valvulopathy, etc.).
- Contraindication to MRI examination, particularly in the presence of an implantable pacemaker or defibrillator, implanted pump, cochlear implants, neurosurgical clips, intraorbital or encephalic metallic foreign bodies,
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 |
|---|---|---|
| Cardiac MRIInjected cardiac MRI | Procedure or surgery | Group A (a) : patients without mitral regurgitation without ventricular extrasystole (≤10/hour) |
| Blood collectionBlood collection (including genetics at the inclusion visit) | Other | Group A (a) : patients without mitral regurgitation without ventricular extrasystole (≤10/hour), Group A (b) : patients without mitral regurgitation with ventricular extrasystole (>10/hour), Group B : patients with Mitral valve prolapse with trivial mitral regurgitation, Group C : patients with Mitral valve prolapse with moderate or mild mitral regurgitation, Group D : patients with asymptomatic Mitral valve prolapse with severe mitral regurgitation |
| Prolongation of the MRI examinationProlongation of the MRI examination (4D flow sequence ; about 10 min) | Procedure or surgery | Group A (b) : patients without mitral regurgitation with ventricular extrasystole (>10/hour), Group B : patients with Mitral valve prolapse with trivial mitral regurgitation, Group C : patients with Mitral valve prolapse with moderate or mild mitral regurgitation, Group D : patients with asymptomatic Mitral valve prolapse with severe mitral regurgitation |
Primary outcome
Presence of ventricular remodelling
Time frame: 3 years
Variation of at least 10% of the telestolic volume observed at 3 years on cardiac MRI compared to the initial cardiac MRI
Presence of ventricular arrythmia (fibrillation or tachycardia, extrasystoles)
Time frame: 3 years
Occurrence of any ventricular arrythmia on external loop recording or exercise ECG
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2026.
- Individual participant dataSharing planned: No
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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?
A study testing Cardiac MRI, Blood collection and Prolongation of the MRI examination in people with Mitral Valve Prolapse, run by Central Hospital, Nancy, France 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 5 inclusion and 11 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: under way, not looking for participants, as of the sponsor's last update on 18 Jun 2026. 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?
This study is still under way. Results are not available in the source record yet.
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?
Presence of ventricular remodelling (time frame: 3 years). The study lists 2 primary outcomes in all. 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 18 Jun 2026.