Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT04852731

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

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Nancy University Hospital

Vandœuvre-lès-Nancy, France, 54511

Actively Recruiting

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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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STretch and Myocardial Characterization in Arrythmogenic Mitral Valve Prolapse-2 | DecenTrialz