About this trial
This is a multicenter, observational prospective and retrospective study which aims are: 1) to compute a scoring model potentially predictive for the diagnosis of fibrosis by CMR in patients with MVP; 2) to identify specific features that may predispose to ≥ mild VAs or SCD in patients with MVP.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
age ≥ 18 years
Echocardiographic diagnosis of mitral valve prolaspe, defined as a systolic displacement of one or both mitral leaflets ≥ 2 mm above the plane of the mitral valve annulus in long-axis views
Disqualifiers
age< 18 years
coexistence of other cardiomyopathies or other ≥ moderate valve diseases
scarce acoustic transthoracic echocardiographic window
usual contraindications for cardiac magnetic resonance
Trial population
Patients with a diagnosis of mitral valve prolapse by transthoracic echocardiography, independent of mitral regurgitation grade, either affected by Barlow's disease, fibroelastic deficiency, forme frustae of mitral valve prolapse.
Trial design
Cohort
Other
Treatments tested in this trial
Not listed
Trial groups
Trial outcomes
Primary outcomes
Prediction of fibrosis by CMR
Clinical, echocardiographic, electrocardiographic, and 24h-ECG monitoring variables will be collected in order to identify potential predictors of fibrosis as detected by cardiac magnetic resonance (CMR). Specifically, the following parameters will be collected. * Clinical data: * Transthoracic echocardiography parameters: * Rest ECG parameters: * 24h electrocardiographic monitoring parameters: * Ventricular arrhythmias (VAs) will be classified as suggested in the recently published EHRA consensus statement * CMR parameters, applying the protocol of the Society of Cardiovascular Magnetic Resonance
Secondary outcomes
Prediction of ≥ mild Ventricular Arrhythmias and/or Sudden cardiac death in mitral valve
Clinical, echocardiographic, electrocardiographic, and CMR variables will be collected in order to identify potential predictors of ≥mild VAs, as defined by the recently published EHRA consensus document. An accurate description of these variables and the Units of Measure are the same as those reported in the section "Primary Outcome Measures".
Clinical data
* gender (female/male), and age in years; * family history for sudden cardiac death; * previous documentation of supraventricular and/or ventricular arrhythmias (VAs); * previous secondary prevention ICD implantation, previous transcatheter ablation of VAs; * symptoms (history of unexplained syncope/pre-syncope, palpitations, dyspnea, chest pain); * signs (mid-systolic click, murmurs of mitral regurgitation); * use of anti-arrhythmic drugs and/or beta-blockers.
Transthoracic echocardiography parameters:
* left atrial biplane volume in mL/m2; * presence, localization, and end-systolic measurement in millimeters of mitral annular disjunction (MAD); * mitral leaflet thickness in millimeters, presence of bileaflet prolapse; * mitral regurgitation (MR) grade, quantified by integrating qualitative and quantitative criteria according to the European guidelines; * left ventricular (LV) diameters in millimeters, volumes in mL/m2, and ejection fraction in %; * presence of curling of the posterolateral LV wall; * presence of the Pickelhaube sign at tissue Doppler imaging; * right ventricular end-diastolic area in cm2/m2, TAPSE in millimeters, and fractional area change in %; * systolic pulmonary artery pressure in mmHg, derived from the peak velocity of the tricuspid regurgitation and from the estimated right atrial pressure.
Rest ECG parameters:
* baseline rhythm (sinus rhythm, atrial fibrillation/flutter, junctional rhythm); * PQ and QRS intervals in milliseconds; * T wave inversion or biphasic T waves in the inferior and lateral leads; * QTc interval in milliseconds; * occurrence of premature supraventricular complexes; * occurrence of premature ventricular complexes (PVCs).
Sponsors and contacts
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Centro Cardiologico Monzino
Lead sponsor
Humanitas Hospital, Italy
Collaborator
IRCCS Ospedale San Raffaele
Collaborator
Azienda Ulss 2 Marca Trevigiana
Collaborator