Prospective Multicenter Study on Mitral Annular Disjunction

Mitral Valve Disease Clinical Trial

— MAD-NesS  

Official title:

Observational Cohort Prospective Multicenter Study on Mitral Annular Disjunction (MAD) - MAD multiceNter Study (MAD-NesS)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04916535
• Other study ID #: 367/2021/Oss/AOUFe
• Status: Recruiting
• Phase: N/A
• Start date: June 3, 2021
• Est. completion date: September 30, 2028

Study information

• Verified date: May 2024
• Source: University Hospital of Ferrara
• Contact: Chiara Manzalini, BsC
• Phone: 0532239898
• Email: chiara88manzalini[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: September 30, 2028
• Est. primary completion date: July 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Mitral Valve Disease

Intervention

Other:
• diagnostic flow
exams to estimate the risk of adverse events in patients with MAD

Locations

Country	Name	City	State
Italy	Cardiology Unit	Bologna
Italy	University Hospital of Ferrara	Ferrara
Italy	Morgagni Hospital	Forlì
Italy	Cardiology Unit	Palermo
Italy	Santa Maria delle Croci Hospital	Ravenna
Italy	Cardiology Unit	Rimini
Italy	University Hospital fo Trieste	Trieste

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital of Ferrara

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological findings associated with MAD	Percentage of subjects with MAD whom deeper analysis with cardiological visit, electrocardiogram (ECG), 24-hour ECG Holter monitoring and cardiac magnetic resonance (CMR) identifies pathological findings. Pathological findings are defined as follows: -T wave inversion in inferolateral leads at ECG; frequent premature ventricular complexes (>1000/24h); non-sustained ventricular arrythmias; sustained ventricular arrythmias; severe mitral regurgitation; myocardial fibrosis with a non-ischemic pattern, especially of papillary muscles and inferolateral wall. The primary endpoint will be considered achieved if at least one of the above mentioned paramentrs will be found in the patient	3 months
Secondary	surgery for mitral valve	occurrence of mitral surgery	5 years
Secondary	sudden cardiac death	occurrence of sudden cardiac death	5 years
Secondary	aborted cardiac arrest	occurrence of aborted cardiac arrest	5 years
Secondary	ventricular arrhythmia	occurrence of non-sustained and/or sustained ventricular tachycardia	5 years