Understanding heart changes in patients with mitral valve prolapse
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)
This study is trying to see how mitral valve prolapse affects the heart over time and if it leads to serious heart rhythm problems in patients.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 280 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Central Hospital, Nancy, France Academic / other |
| Locations | 1 site (Vandœuvre-lès-Nancy) |
| Trial ID | NCT04852731 on ClinicalTrials.gov |
What this trial studies
This study investigates the relationship between mitral valve prolapse (MVP) and changes in the heart's structure and function over time. It aims to assess myocardial fibrosis and mitral ring disjunction in patients with MVP, which may lead to severe ventricular arrhythmias. Participants will undergo cardiac MRI and blood collection to gather data on their condition. The study seeks to better understand how MVP can progress and affect heart health.
Who should consider this trial
Good fit: Ideal candidates are adults over 18 years old diagnosed with mitral valve prolapse.
Not a fit: Patients with severe mitral regurgitation requiring surgery or those with severe rhythm disorders may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved monitoring and treatment strategies for patients with mitral valve prolapse.
How similar studies have performed: While there have been studies on mitral valve prolapse, this specific approach focusing on myocardial fibrosis and ventricular remodeling is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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 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.
Where this trial is running
Vandœuvre-lès-Nancy
- Nancy University Hospital — Vandœuvre-lès-Nancy, France (Recruiting)
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.