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)

Status: Recruiting
Location: See location...
Intervention Type: Procedure, Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
France
Nancy University Hospital
RECRUITING
Vandœuvre-lès-nancy
Time Frame
Start Date: 2021-08-30
Estimated Completion Date: 2027-07-01
Participants
Target number of participants: 280
Treatments
Experimental: Group A (a) : patients without mitral regurgitation without ventricular extrasystole (≤10/hour)
These patients will undergo at the inclusion and 36 months after the inclusion :~* According to recommendations : echocardiography, 24-hour external loop recording and exercise ECG,~* And specifically for research purposes : injected cardiac MRI and a blood collection.
Experimental: Group A (b) : patients without mitral regurgitation with ventricular extrasystole (>10/hour)
These patients will undergo at the inclusion and 36 months after the inclusion :~* According to recommendations : echocardiography, 24-hour external loop recording, exercise ECG, injected cardiac MRI,~* And specifically for research purposes : prolongation of the MRI examination (4D flow sequence) and a blood collection.
Experimental: Group B : patients with Mitral valve prolapse with trivial mitral regurgitation
These patients will undergo at the inclusion and 36 months after the inclusion :~* According to recommendations : echocardiography, 24-hour external loop recording, exercise ECG, injected cardiac MRI,~* And specifically for research purposes : prolongation of the MRI examination (4D flow sequence) and a blood collection.
Experimental: Group C : patients with Mitral valve prolapse with moderate or mild mitral regurgitation
These patients will undergo at the inclusion and 36 months after the inclusion :~* According to recommendations : echocardiography, 24-hour external loop recording, exercise ECG, injected cardiac MRI,~* And specifically for research purposes : prolongation of the MRI examination (4D flow sequence) and a blood collection.
Experimental: Group D : patients with asymptomatic Mitral valve prolapse with severe mitral regurgitation
These patients will undergo at the inclusion and 36 months after the inclusion :~* According to recommendations : echocardiography, 24-hour external loop recording, exercise ECG, injected cardiac MRI,~* And specifically for research purposes : prolongation of the MRI examination (4D flow sequence) and a blood collection.
Sponsors
Leads: Central Hospital, Nancy, France

This content was sourced from clinicaltrials.gov