STretch and Myocardial Characterization in Arrythmogenic Mitral Valve Prolapse-2

Launched by CENTRAL HOSPITAL, NANCY, FRANCE · Apr 16, 2021

Keywords

ClinConnect Summary

The clinical trial titled "STretch and Myocardial Characterization in Arrhythmogenic Mitral Valve Prolapse-2" is investigating how mitral valve prolapse (MVP) can affect the heart over time. MVP is a common heart condition where the mitral valve doesn’t close properly, which can sometimes lead to heart problems like irregular heartbeats or worsening valve function. The researchers aim to understand how changes in the heart’s structure and function, such as scarring of the heart muscle, can predict the risk of serious heart issues in patients with MVP. They hope that by identifying specific markers and using advanced imaging techniques, they can find out which patients might be at higher risk for these problems in the future.

To be eligible for this study, participants need to be adults over 18 years old diagnosed with MVP. They should be in good health without severe valve issues that require surgery or other significant heart conditions. Those who join the study will undergo various tests, including heart imaging and monitoring, to help researchers gather important information about their heart health over a three-year period. It’s important to note that the study is currently recruiting participants, and anyone interested should have a discussion with their healthcare provider to see if they qualify.

Gender

ALL

Eligibility 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.