Clinical trial NCT04916535: Prospective Multicenter Study on Mitral Annular Disjunction
Official title: Observational Cohort Prospective Multicenter Study on Mitral Annular Disjunction (MAD) - MAD MulticeNter Study (MAD-NesS)
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Mitral Valve Disease
Keywords: mitral annular disjunction
Lead sponsor: University Hospital of Ferrara
Sponsor class: OTHER
First posted: 2021-06-07
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention model description: Observational cohort prospective multicenter study on patients with MAD
Primary purpose: OTHER

Brief summary: Observational cohort prospective multicenter study on patients with mitral annular disjunction (MAD). MAD is defined as a separation (≥1 mm) between the atrial wall-mitral valvular junction and the left ventricular free wall during end-systole

Detailed description: Mitral annular disjunction (MAD) is a structural abnormality of the mitral annulus, defined as a separation (≥1 mm) between the atrial wall-mitral valvular junction and the left ventricular free wall during end-systole. This abnormality is significantly associated with the presence of mitral valve prolapse (MVP), but it can also be observed in normal hearts. MAD-related hypermobility of the mitral apparatus and the consequent posterior systolic curling determine a mechanical stress of the infero-basal wall and papillary muscle. This phenomenon leads to myocardial hypertrophy and fibrosis, creating an arrhythmogenic substrate and a source of electrical instability. For this reason, the analysis of left ventricle by cardiac magnetic resonance plays a pivotal role in the identification of predictors of fatal arrhythmic events, such as sudden cardiac death (SCD). Taking into account that MAD could be present without MVP, some studies analyzed the association between MAD and arrhythmic events. They showed that MAD itself is a risk marker of electrical instability supporting the existence of an emerging clinical entity: the MAD arrhythmic syndrome. An in deep analysis of MAD patients and their characteristics in terms of EKG, types of arrhythmia, echocardiographic parameters and cardiac magnetic resonance (CMR) data and long-term events is lacking.

The present study is ideated and conducted to fill this gap and collect information regarding management and outcome of patients with MAD

Eligibility criteria: Inclusion criteria:

* Subject aged ≥18 years and \<65 years
* Evidence of MAD during routine echocardiography clinically indicated by treating physician for any reason
* Written informed consent

Exclusion criteria:

• Patient's refusal

Primary outcomes:
measure: Pathological findings associated with MAD
timeFrame: 3 months
Secondary outcomes:
measure: surgery for mitral valve
timeFrame: 5 years
measure: sudden cardiac death
timeFrame: 5 years
measure: aborted cardiac arrest
timeFrame: 5 years
measure: ventricular arrhythmia
timeFrame: 5 years
Other outcomes:
Locations:
city: Bologna
country: Italy
facility: Cardiology Unit
city: Ferrara
country: Italy
facility: University Hospital of Ferrara
city: Forlì
country: Italy
facility: Morgagni Hospital
city: Palermo
country: Italy
facility: Cardiology Unit
city: Ravenna
country: Italy
facility: Santa Maria delle Croci Hospital
city: Rimini
country: Italy
facility: Cardiology Unit
city: Trieste
country: Italy
facility: University Hospital fo Trieste
Study officials:
affiliation: University Hospital of Ferrara
name: Elisabetta Tonet, MD
role: PRINCIPAL_INVESTIGATOR
References: