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

NCT06341166 | Recruiting

• 1 other identifier: CCM1959
• Study Type: observational
• Target: 300
• Locations: 1 country
• Sites: 1

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.

Conditions

Mitral Valve Prolapse

Outcome Measures

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

  June 2026

Secondary Outcomes (6)

• Prediction of ≥ mild Ventricular Arrhythmias and/or Sudden cardiac death in mitral valve

  June 2026

• Clinical data

  June 2026

• Transthoracic echocardiography parameters:

  June 2026

• Rest ECG parameters:

  June 2026

• 24h electrocardiographic monitoring parameters:

  June 2026

Study Arms (2)

Prospective Cohort

Prospectively enrolled patients will undergo a complete assessment, as clinically indicated, including clinical evaluation, TTE, rest ECG, 24h ECG-monitoring, and CMR. CMR will be performed no more than 6 months apart from other examinations (TTE, rest ECG, 24h ECG-monitoring).

Retrospective Cohort

Patients will be enrolled retrospectively, in case they have already performed all examinations between 2016 and 2023

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Centro Cardiologico Monzino: lead
• Humanitas Hospital, Italy: collaborator
• IRCCS Ospedale San Raffaele: collaborator
• Azienda Ulss 2 Marca Trevigiana: collaborator

Study Sites (1)

Centro Cardiologico Monzino

Milan, Milan, 20131, Italy

RECRUITING

MeSH Terms

Conditions

Mitral Valve Prolapse

Condition Hierarchy (Ancestors)

Heart Valve Prolapse; Heart Valve Diseases; Heart Diseases; Cardiovascular Diseases

Central Study Contacts

Gianluca Pontone, MD

CONTACT

0258002574; gianluca.pontone@cardiologicomonzino.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 14, 2024
• First Posted: April 2, 2024
• Study Start: June 19, 2023
• Primary Completion (Estimated): June 19, 2026
• Study Completion (Estimated): June 19, 2026
• Last Updated: February 3, 2026

Record last verified: 2026-01

Locations

IT (1)