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)

Central Hospital, Nancy, France2 个研究点分布在 1 个国家目标入组 280 人开始时间: 2021年8月30日最近更新: 2026年6月18日

适应症

干预措施

试验速览

阶段: 不适用
状态: 进行中（未招募）
发起方
入组人数: 280
试验地点: 2
主要终点: Presence of ventricular remodelling

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

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.

研究设计

研究类型: Interventional
分配方式: Non Randomized
干预模型: Parallel
主要目的: Diagnostic
盲法: None

入排标准

年龄范围: 18 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•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

排除标准

•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.