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Clinical Trials/NCT02879825
NCT02879825
Completed
N/A

Myocardial Characterization of Arrhythmogenic Mitral Valve Prolapse

Central Hospital, Nancy, France1 site in 1 country239 target enrollmentDecember 20, 2016

Overview

Phase
N/A
Intervention
Not specified
Conditions
Mitral Valve Prolapse
Sponsor
Central Hospital, Nancy, France
Enrollment
239
Locations
1
Primary Endpoint
Evidence of ventricular arrythmia (premature ventricular contraction or tachycardia)
Status
Completed
Last Updated
4 years ago

Overview

Brief Summary

Mitral valve prolapse (MVP) is a frequent affection of the mitral valve or its sub-valvular apparatus 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 and only patients with significant mitral regurgitation will undergo subsequent examination (24-hour external loop recording, exercise ECG, cardiac MRI) and a close follow-up.

External loop recording and exercise ECG have an interest in the identification of patients presenting with arrhythmic complications, such as premature ventricular contractions, and in the global evaluation of hemodynamic consequences of the mitral regurgitation.

More recently, detection of myocardial fibrosis among patients with MVP and severe ventricular arrhythmia has been identified. Fibrosis could evolve independently of the valvular regurgitation's severity and could be a substrate (myocardial scar) leading to ventricular arrhythmia. However, no study has specifically characterized myocardial lesions among patients with MVP and none, or not significant, mitral regurgitation. Using cardiac magnetic resonance imaging (MRI), gold standard technique in myocardial imaging and characterization, and echocardiography, particularly speckle-tracking imaging, identification of static (fibrosis) and/or dynamic (ventricular systolic deformation patterns using speckle-tracking strain) myocardial lesions.

Identification of patients with impaired deformation patterns, fibrosis or with premature ventricular contractions may isolate a sub-group of patients with a higher risk of severe ventricular arrhythmia for whom a closer follow-up could be justified.

Registry
clinicaltrials.gov
Start Date
December 20, 2016
End Date
May 31, 2021
Last Updated
4 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Central Hospital, Nancy, France
Responsible Party
Principal Investigator
Principal Investigator

Dr Olivier HUTTIN

Medical Doctor

Central Hospital, Nancy, France

Eligibility Criteria

Inclusion Criteria

  • Mitral valve prolapse diagnosed in echocardiography
  • Signed written consent
  • Affiliation to social security
  • No contraindication to MRI or exercise ECG
  • Age above 18

Exclusion Criteria

  • Mitral valve prolapse with severe regurgitation and instable hemodynamic state requiring urgent surgery
  • Prior MRI with contrast within the last month
  • Prior diagnosis of primary cardiomyopathy potentially responsible for myocardial fibrosis
  • Contraindication to exercise ECG: severe handicap, poor physical capacity
  • Contraindication to MRI: implantable device, claustrophobia, metal debris
  • Renal insufficiency with creatinine clearance \<30 ml/min or prior serious side effect related to infusion of a magnetic contrast agent
  • Pregnant or breast-feeding women
  • Minors \<18 years old
  • Mental illness or incapacity with incapacity to obtain informed consent

Outcomes

Primary Outcomes

Evidence of ventricular arrythmia (premature ventricular contraction or tachycardia)

Time Frame: Within 15 days

Occurrence of any ventricular arrythmia on external loop recording or exercise ECG

Evidence of myocardial fibrosis on cardiac MRI

Time Frame: Within 15 days

Visualisation of any late gadolinium enhancement

Secondary Outcomes

  • Estimation of mitral regurgitation severity on echocardiography(At inclusion)
  • Description and evaluation of ventricular myocardial deformation patterns(Within 15 days)
  • Comparative evaluation of mitral regurgitation using echocardiography and cardiac MRI(Within 15 days)

Study Sites (1)

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