Mitral Valve ProlapseSTAMPNCT02879825
Myocardial Characterization of Arrhythmogenic Mitral Valve Prolapse (STAMP: STretch and Myocardial Characterization in Arrhythmogenic Mitral Valve Prolapse)
A study testing Cardiac MRI 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 or its sub-valvular apparatus 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
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 239 participants
- Where
- 1 siteFrance
- Study dates
- 20 Dec 2016to 31 May 2021
- 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
- Mitral valve prolapse diagnosed in echocardiography
- Signed written consent
- Affiliation to social security
- No contraindication to MRI or exercise ECG
- Age above 18
Who cannot join
- Mitral valve prolapse with severe regurgitation and instable hemodynamic state requiring urgent surgery
- Prior MRI with contrast within the last month
- Prior diagnosis of primary cardiomyopathy potentially responsible for myocardial fibrosis
- Contraindication to exercise ECG: severe handicap, poor physical capacity
- Contraindication to MRI: implantable device, claustrophobia, metal debris
- Renal insufficiency with creatinine clearance <30 ml/min or prior serious side effect related to infusion of a magnetic contrast agent
Show all 9Show fewer
- Pregnant or breast-feeding women
- Minors <18 years old
- Mental illness or incapacity with incapacity to obtain informed consent
Trial locations and contacts
1 site in 1 country.
France1 site
Nancy University Hospital, Department of Cardiology
Vandœuvre-lès-Nancy, 54511
About this study
Official title: Myocardial Characterization of Arrhythmogenic Mitral Valve Prolapse
Mitral valve prolapse (MVP) is a frequent affection of the mitral valve or its sub-valvular apparatus 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 and only patients with significant mitral regurgitation will undergo subsequent examination (24-hour external loop recording, exercise ECG, cardiac MRI) and a close follow-up.
Read more
External loop recording and exercise ECG have an interest in the identification of patients presenting with arrhythmic complications, such as premature ventricular contractions, and in the global evaluation of hemodynamic consequences of the mitral regurgitation.
More recently, detection of myocardial fibrosis among patients with MVP and severe ventricular arrhythmia has been identified. Fibrosis could evolve independently of the valvular regurgitation's severity and could be a substrate (myocardial scar) leading to ventricular arrhythmia. However, no study has specifically characterized myocardial lesions among patients with MVP and none, or not significant, mitral regurgitation. Using cardiac magnetic resonance imaging (MRI), gold standard technique in myocardial imaging and characterization, and echocardiography, particularly speckle-tracking imaging, identification of static (fibrosis) and/or dynamic (ventricular systolic deformation patterns using speckle-tracking strain) myocardial lesions.
Identification of patients with impaired deformation patterns, fibrosis or with premature ventricular contractions may isolate a sub-group of patients with a higher risk of severe ventricular arrhythmia for whom a closer follow-up could be justified.
- Conditions
- Mitral Valve Prolapse
- Being tested
- Cardiac MRI
- Keywords
- Ventricular Premature Complexes
- Medical subject headings
- Mitral Valve Prolapse, Ventricular Premature Complexes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Cardiac MRIDevice
Also called 24-hour external loop recording, Exercise ECG
Group-A patients, with mitral valve prolapse but no mitral regurgitation, will undergo specifically for research purposes a cardiac MRI, 24-hour external loop recording and exercise ECG on top of regular echocardiography evaluation.
Realization of these examinations will be performed according to recommendations for patients with mitral regurgitation (groups B, C and D)
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Mitral valve prolapse without mitral regurgitation Receives: Device: Cardiac MRI |
| Group B | Experimental | Mitral valve prolapse with trivial mitral regurgitation Receives: Device: Cardiac MRI |
| Group C | Experimental | Mitral valve prolapse with moderate or mild mitral regurgitation and asymptomatic Receives: Device: Cardiac MRI |
| Group D | Experimental | Mitral valve prolapse with severe mitral regurgitation or symptomatic Receives: Device: Cardiac MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of ventricular arrythmia (premature ventricular contraction or tachycardia)
Occurrence of any ventricular arrythmia on external loop recording or exercise ECG
Measured: Within 15 days
Evidence of myocardial fibrosis on cardiac MRI
Visualisation of any late gadolinium enhancement
Measured: Within 15 days
Secondary outcomes (3)
Estimation of mitral regurgitation severity on echocardiography
Measured: At inclusion
Description and evaluation of ventricular myocardial deformation patterns
Comparison of deformation patterns using speckle-tracking echocardiography and strain in cardiac MRI
Measured: Within 15 days
Comparative evaluation of mitral regurgitation using echocardiography and cardiac MRI
Measured: Within 15 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2016 (estimated)
- Study start20 Dec 2016
- Primary completion31 May 2021
- Study completion31 May 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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 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
- 239 participants (actual)
Sponsor and investigators
- Lead sponsor
- Central Hospital, Nancy, France
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Olivier HUTTIN, Central Hospital, Nancy, France
- Investigators
- Olivier HUTTIN, MD, MSc, Principal investigator, Department of Cardiology, Nancy University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02879825
- Sponsor's protocol ID
- 2016-A00954-47
- Acronym
- STAMP
- Status last verified
- Jan 2022
- First submitted
- 23 Aug 2016
- Last updated
- 3 Feb 2022
- Results posted
- No
- Data monitoring committee
- No
Publications
Basso C, Perazzolo Marra M, Rizzo S, De Lazzari M, Giorgi B, Cipriani A, Frigo AC, Rigato I, Migliore F, Pilichou K, Bertaglia E, Cacciavillani L, Bauce B, Corrado D, Thiene G, Iliceto S. Arrhythmic Mitral Valve Prolapse and Sudden Cardiac Death. Circulation. 2015 Aug 18;132(7):556-66. doi: 10.1161/CIRCULATIONAHA.115.016291. Epub 2015 Jul 9.
PubMed 26160859Huttin O, Pierre S, Venner C, Voilliot D, Sellal JM, Aliot E, Sadoul N, Juilliere Y, Selton-Suty C. Interactions between mitral valve and left ventricle analysed by 2D speckle tracking in patients with mitral valve prolapse: one more piece to the puzzle. Eur Heart J Cardiovasc Imaging. 2017 Mar 1;18(3):323-331. doi: 10.1093/ehjci/jew075.
PubMed 27099279Huttin 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 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Myocardial Characterization of Arrhythmogenic Mitral Valve Prolapse
- ClinicalTrials.gov ID
- NCT02879825
- Acronym / sponsor ID
- STAMP / 2016-A00954-47
- Conditions
- Mitral Valve Prolapse
- Keywords
- Ventricular Premature Complexes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 239 participants (actual)
- Lead sponsor
- Central Hospital, Nancy, FranceUniversity, hospital or other
- Study start
- 20 Dec 2016 (actual)
- Primary completion
- 31 May 2021 (actual)
- Study completion
- 31 May 2021 (actual)
- First posted
- 26 Aug 2016 (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.
Mitral valve prolapse (MVP) is a frequent affection of the mitral valve or its sub-valvular apparatus 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 and only patients with significant mitral regurgitation will undergo subsequent examination (24-hour external loop recording, exercise ECG, cardiac MRI) and a close follow-up.
External loop recording and exercise ECG have an interest in the identification of patients presenting with arrhythmic complications, such as premature ventricular contractions, and in the global evaluation of hemodynamic consequences of the mitral regurgitation.
More recently, detection of myocardial fibrosis among patients with MVP and severe ventricular arrhythmia has been identified. Fibrosis could evolve independently of the valvular regurgitation's severity and could be a substrate (myocardial scar) leading to ventricular arrhythmia. However, no study has specifically characterized myocardial lesions among patients with MVP and none, or not significant, mitral regurgitation. Using cardiac magnetic resonance imaging (MRI), gold standard technique in myocardial imaging and characterization, and echocardiography, particularly speckle-tracking imaging, identification of static (fibrosis) and/or dynamic (ventricular systolic deformation patterns using speckle-tracking strain) myocardial lesions.
Identification of patients with impaired deformation patterns, fibrosis or with premature ventricular contractions may isolate a sub-group of patients with a higher risk of severe ventricular arrhythmia for whom a closer follow-up could be justified.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Device: Cardiac MRIMitral valve prolapse without mitral regurgitation |
| Group B | Experimental | Device: Cardiac MRIMitral valve prolapse with trivial mitral regurgitation |
| Group C | Experimental | Device: Cardiac MRIMitral valve prolapse with moderate or mild mitral regurgitation and asymptomatic |
| Group D | Experimental | Device: Cardiac MRIMitral valve prolapse with severe mitral regurgitation or symptomatic |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Mitral valve prolapse diagnosed in echocardiography
- Signed written consent
- Affiliation to social security
- No contraindication to MRI or exercise ECG
- Age above 18
Key exclusion criteria (9 listed)
- Mitral valve prolapse with severe regurgitation and instable hemodynamic state requiring urgent surgery
- Prior MRI with contrast within the last month
- Prior diagnosis of primary cardiomyopathy potentially responsible for myocardial fibrosis
- Contraindication to exercise ECG: severe handicap, poor physical capacity
- Contraindication to MRI: implantable device, claustrophobia, metal debris
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 MRIAlso: 24-hour external loop recording, Exercise ECGGroup-A patients, with mitral valve prolapse but no mitral regurgitation, will undergo specifically for research purposes a cardiac MRI, 24-hour external loop recording and exercise ECG on top of regular echocardiography evaluation. Realization of these examinations will be performed according to recommendations for patients with mitral regurgitation (groups B, C and D) | Device | Group A, Group B, Group C, Group D |
Primary outcome
Evidence of ventricular arrythmia (premature ventricular contraction or tachycardia)
Time frame: Within 15 days
Occurrence of any ventricular arrythmia on external loop recording or exercise ECG
Evidence of myocardial fibrosis on cardiac MRI
Time frame: Within 15 days
Visualisation of any late gadolinium enhancement
3 secondary outcomes
Estimation of mitral regurgitation severity on echocardiography
Time frame: At inclusion
Description and evaluation of ventricular myocardial deformation patterns
Time frame: Within 15 days
Comparative evaluation of mitral regurgitation using echocardiography and cardiac MRI
Time frame: Within 15 days
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 3 Feb 2022.
- Background: PubMed 26160859Basso C, Perazzolo Marra M, Rizzo S, De Lazzari M, Giorgi B, Cipriani A, Frigo AC, Rigato I, Migliore F, Pilichou K, Bertaglia E, Cacciavillani L, Bauce B, Corrado D, Thiene G, Iliceto S. Arrhythmic Mitral Valve Prolapse and Sudden Cardiac Death. Circulation. 2015 Aug 18;132(7):556-66. doi: 10.1161/CIRCULATIONAHA.115.016291. Epub 2015 Jul 9.
- Background: PubMed 27099279Huttin O, Pierre S, Venner C, Voilliot D, Sellal JM, Aliot E, Sadoul N, Juilliere Y, Selton-Suty C. Interactions between mitral valve and left ventricle analysed by 2D speckle tracking in patients with mitral valve prolapse: one more piece to the puzzle. Eur Heart J Cardiovasc Imaging. 2017 Mar 1;18(3):323-331. doi: 10.1093/ehjci/jew075.
- 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.
Related trials for Mitral Valve Prolapse
Active, not recruitingPhase 3
Effect and Safety of Flecainide and Metoprolol Versus Metoprolol Alone to Suppress Ventricular Arrhythmias in Arrhythmic Mitral Valve Prolapse
Mitral Valve Prolapse, Ventricular Arrhythmias and Cardiac Arrest
RecruitingObservational study
Korea VHD Echo Study: Surveillance of Aortic, Mitral & Tricuspid Patients - Insights From Real-world Practice
Heart Valve Diseases, Aortic Valve Stenosis
Active, not recruiting
Percutaneous or Surgical Repair In Mitral Prolapse And Regurgitation for ≥60 Year-olds (PRIMARY)
Mitral Valve Regurgitation
RecruitingObservational study
Mitral Valve Prolapse Arrhythmic Risk
Mitral Valve Prolapse, Ventricular Arrhythmias and Cardiac Arrest
RecruitingObservational study
Multiparametric SCores for Prediction of Myocardial fIbrosis in Patients With MITral vAlve pRolapse
Mitral Valve Prolapse
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.
Olivier HUTTIN, MD, MSc principal investigator
Department of Cardiology, Nancy University Hospital
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 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 9 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 3 Feb 2022. 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?
Evidence of ventricular arrythmia (premature ventricular contraction or tachycardia) (time frame: Within 15 days). 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?
On the ClinicalTrials.gov record for NCT02879825, which also lists 3 linked publications.
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 3 Feb 2022.