Multiparametric SCores for Prediction of Myocardial fIbrosis in Patients With MITral vAlve pRolapse

Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCentro Cardiologico Monzino

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 volunteers

Qualifiers

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

Design model

Cohort

Time perspective

Other

Treatments tested in this trial

Not listed

Trial groups

300 Participants
are grouped into 2 trial groups
Group A: Prospective Cohort
Group B: Retrospective Cohort

Trial outcomes

Primary outcomes

1

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

Time frame
June 2026

Secondary outcomes

1

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".

Time frame
June 2026
2

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.

Time frame
June 2026
3

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.

Time frame
June 2026
4

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).

Time frame
June 2026

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Centro Cardiologico Monzino

Lead sponsor

Humanitas Hospital, Italy

Collaborator

IRCCS Ospedale San Raffaele

Collaborator

Azienda Ulss 2 Marca Trevigiana

Collaborator