Clinical trial NCT06341166: Multiparametric SCores for Prediction of Myocardial FIbrosis in Patients with MITral VAlve PRolapse
Official title: Multiparametric SCores for Prediction of Myocardial FIbrosis in Patients with MITral VAlve PRolapse: the SCIMITAR Trial
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Mitral Valve Prolapse
Lead sponsor: Centro Cardiologico Monzino
Sponsor class: OTHER
Collaborators: name: Humanitas Hospital, Italy
name: IRCCS Ospedale San Raffaele
name: Azienda Ulss 2 Marca Trevigiana
First posted: 2024-04-02
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: OTHER
Sampling method: NON_PROBABILITY_SAMPLE
Study 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.

Brief summary: 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.

Detailed description: Patients with mitral valve prolapse and non-significant mitral regurgitation generally have a good prognosis. A minority of patients with MVP suffers from ventricular arrhythmias. Different demographic, clinical, and electrocardiographic characteristics, as well as morphological and structural features of the MV were described as potential risk factors for ventricular arrhythmias, among which fibrosis of the left ventricular inferolateral wall and posterior papillary muscle as detected by cardiac magnetic resonance.

As cardiac magnetic resonance has some limitations, it is unknown if and which patients with mitral valve prolapse should undergo cardiac magnetic resonance in routine clinical practice, to search for late gadolinium enhancement as a surrogate for myocardial fibrosis.

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* age\< 18 years
* coexistence of other cardiomyopathies or other ≥ moderate valve diseases
* scarce acoustic transthoracic echocardiographic window
* usual contraindications for cardiac magnetic resonance

Primary outcomes:
measure: Prediction of fibrosis by CMR
timeFrame: June 2026
Secondary outcomes:
measure: Prediction of ≥ mild Ventricular Arrhythmias and/or Sudden cardiac death in mitral valve
timeFrame: June 2026
measure: Clinical data
timeFrame: June 2026
measure: Transthoracic echocardiography parameters:
timeFrame: June 2026
measure: Rest ECG parameters:
timeFrame: June 2026
measure: 24h electrocardiographic monitoring parameters:
timeFrame: June 2026
measure: CMR parameters
timeFrame: June 2026
Other outcomes:
Locations:
city: Milan
country: Italy
facility: Centro Cardiologico Monzino
Study officials:
References: