Active — Not RecruitingNot Applicable

STretch and Myocardial Characterization in Arrythmogenic Mitral Valve Prolapse-2

France280 participantsStarted 2021-08-30

Plain-language 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. 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * 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 Exclusion Criteria: * 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, * Motor or mental disabi…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1This study is specifically focused on 'arrhythmogenic' mitral valve prolapse — does my type of MVP carry the kind of electrical or rhythm risks that would make my case relevant to what this study is investigating?
2The trial is no longer enrolling new patients, so could my doctor still use the same imaging and monitoring approaches being studied here — like the ones looking at ventricular remodelling and arrhythmias — to better evaluate my own situation outside of the trial?
3Since the study is measuring both ventricular remodelling and abnormal heart rhythms like fibrillation, tachycardia, and extrasystoles, should I be getting tested for any of these things as part of my regular MVP care, and am I currently being monitored closely enough?
4What does it mean for my safety if my mitral valve prolapse has any of the features this study is specifically designed to flag — like stretch-related changes to the heart muscle — and how would my doctor act on that information?
5Are there other active studies or standard-of-care options my doctor would recommend before or instead of waiting for results from a study like this one, especially if I'm already showing any arrhythmia symptoms?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Presence of ventricular remodelling

Timeframe: 3 years

Presence of ventricular arrythmia (fibrillation or tachycardia, extrasystoles)

Timeframe: 3 years

Trial details

NCT IDNCT04852731

SponsorCentral Hospital, Nancy, France

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2027-11-29

View on ClinicalTrials.gov More Mitral Valve Prolapse trials