Actively Recruiting
STretch and Myocardial Characterization in Arrythmogenic Mitral Valve Prolapse-2
Led by Central Hospital, Nancy, France · Updated on 2022-08-09
280
Participants Needed
1
Research Sites
304 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
STretch and Myocardial Characterization in Arrythmogenic Mitral Valve Prolapse-2
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Patient over 18 years old
- Diagnosed with mitral valve prolapse
- Provided informed consent after receiving full information about the study
- Affiliated with or beneficiary of social security insurance
- Completed a prior clinical exam without contraindications to planned tests
You will not qualify if you...
- Severe mitral regurgitation with surgical indication
- Severe rhythm disorders requiring a defibrillator implant
- Received injected MRI within one month before the planned MRI
- Diagnosed heart diseases causing myocardial damage that may affect results (e.g., infarction, amyloidosis, systemic scleroderma, significant aortic valve disease)
- Contraindications to MRI (e.g., pacemaker, defibrillator, implanted pump, cochlear implants, neurosurgical clips, metallic foreign bodies in the eye or brain)
- Claustrophobia or body type preventing MRI
- Motor or mental disabilities
- Renal impairment preventing use of Gadolinium contrast
- Allergies to gadoteric acid, meglumine, or gadolinium-containing drugs
- Women of childbearing age without effective contraception
- Individuals referred to Articles L. 1121-5 to L1121-8 of the Public Health Code
AI-Screening
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Trial Site Locations
Total: 1 location
1
Nancy University Hospital
Vandœuvre-lès-Nancy, France, 54511
Actively Recruiting
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
DIAGNOSTIC
Number of Arms
5
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