STretch and Myocardial Characterization in Arrythmogenic Mitral Valve Prolapse-2

Mitral Valve Prolapse Clinical Trial

— STAMP-2  

Official title:

Dynamic Evaluation of Myocardial Fibrosis and Structural Determinants of Ventricular Arrhythmia in Mitral Valve Prolapse (STAMP-2 : STretch and Myocardial Characterization in Arrythmogenic Mitral Valve Prolapse-2)

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04852731
• Other study ID #: 2020-A02680-39
• Status: Recruiting
• Phase: N/A
• Start date: August 30, 2021
• Est. completion date: July 1, 2027

Study information

• Verified date: August 2022
• Source: Central Hospital, Nancy, France
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Mitral valve prolapse (MVP) is a frequent affection of the mitral valve with a prevalence of 2-3% in the general population. This valvular disease is generally considered as benign, but may at term evolve toward mitral valve regurgitation of various severity and/or arrhythmia.

Mitral valve prolapse is routinely diagnosed using transthoracic echocardiography. Subsequent examinations (24-hour external loop recording, exercise electrocardiogram, cardiac Magnetic Resonance Imaging) and a close follow-up can be proposed to the patient depending on its condition.

More recently, detection of myocardial fibrosis and a mitral ring disjunction among patients with MVP were associated with the occurrence of severe ventricular arrhythmia.

The investigators hypothesize that ventricular remodeling over time is mediated by the progression of mitral insufficiency severity from myocardial fibrosis secondary to MVP and possibly promoted by other mitral valve abnormalities. This remodeling, characterized by circulating biomarkers and imaging (MRI and echocardiography), could allow the identification of patients with a higher risk of severe ventricular arrhythmia.

The main objective of this study is to identify prognostic factors for unfavorable evolution (ventricular remodeling or a rhythm disorder event) at 3 years from initial assessments in MVP patients.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 280
• Est. completion date: July 1, 2027
• Est. primary completion date: July 1, 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patient over 18 years old,

• Patient with mitral valve prolapse,

• Patient who has received full information about the organization of the research and has signed an informed consent,

• Patient affiliated to or beneficiary of a social security insurance,

• Patient who has completed a prior clinical examination adapted to the research and who does not show any contraindication to the planned examinations

Exclusion Criteria:

• Stage of the disease: Patients with MVP with severe mitral regurgitation with a surgical indication as defined by current recommendations will not be included in the study,

• Presence of severe rhythm disorders requiring the implantation of a defibrillator (cardiorespiratory arrest recovered, sudden death recovered, etc.),

• Performance of an injected MRI in the month preceding the MRI scheduled during visit n°1,

• Previously diagnosed cardiopathy that may be responsible for myocardial damage (ventricular remodeling, alteration of left ventricular systolic function, fibrosis, etc.) and that may disrupt the interpretation of results (infarction, amyloidosis, systemic scleroderma, significant aortic valvulopathy, etc.).

• Contraindication to MRI examination, particularly in the presence of an implantable pacemaker or defibrillator, implanted pump, cochlear implants, neurosurgical clips, intraorbital or encephalic metallic foreign bodies,

• Claustrophobia or morphotype that does not allow MRI to be performed,

• Motor or mental disability,

• Renal impairment that does not allow the injection of Gadolinium-based contrast media (DOTAREM® or equivalent in the study). If there is any doubt as to the patient's renal function, a plasma creatinine determination will be performed for MRI to ensure the absence of renal failure,

• Hypersensitivity to gadoteric acid, meglumine, or any gadolinium-containing drug.

• Women of childbearing age who do not have effective contraception,

• Persons referred to in Articles L. 1121-5 to L1121-8 of the Public Health Code.

Related Conditions & MeSH terms

• Mitral Valve Prolapse
• Prolapse

Intervention

Procedure:
• Cardiac MRI
Injected cardiac MRI

Other:
• Blood collection
Blood collection (including genetics at the inclusion visit)

Procedure:
• Prolongation of the MRI examination
Prolongation of the MRI examination (4D flow sequence ; about 10 min)

Locations

Country	Name	City	State
France	Nancy University Hospital	Vandœuvre-lès-Nancy

Sponsors (1)

Lead Sponsor	Collaborator
Central Hospital, Nancy, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Presence of ventricular remodelling	Variation of at least 10% of the telestolic volume observed at 3 years on cardiac MRI compared to the initial cardiac MRI	3 years
Primary	Presence of ventricular arrythmia (fibrillation or tachycardia, extrasystoles)	Occurrence of any ventricular arrythmia on external loop recording or exercise ECG	3 years