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STretch and Myocardial Characterization in Arrythmogenic Mitral Valve Prolapse-2 (STAMP-2)

Primary Purpose

Mitral Valve Prolapse

Status
Recruiting
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Cardiac MRI
Blood collection
Prolongation of the MRI examination
Sponsored by
Central Hospital, Nancy, France
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Mitral Valve Prolapse

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • Nancy University HospitalRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm Type

Experimental

Experimental

Experimental

Experimental

Experimental

Arm Label

Group A (a) : patients without mitral regurgitation without ventricular extrasystole (≤10/hour)

Group A (b) : patients without mitral regurgitation with ventricular extrasystole (>10/hour)

Group B : patients with Mitral valve prolapse with trivial mitral regurgitation

Group C : patients with Mitral valve prolapse with moderate or mild mitral regurgitation

Group D : patients with asymptomatic Mitral valve prolapse with severe mitral regurgitation

Arm Description

These patients will undergo at the inclusion and 36 months after the inclusion : According to recommendations : echocardiography, 24-hour external loop recording and exercise ECG, And specifically for research purposes : injected cardiac MRI and a blood collection.

These patients will undergo at the inclusion and 36 months after the inclusion : According to recommendations : echocardiography, 24-hour external loop recording, exercise ECG, injected cardiac MRI, And specifically for research purposes : prolongation of the MRI examination (4D flow sequence) and a blood collection.

These patients will undergo at the inclusion and 36 months after the inclusion : According to recommendations : echocardiography, 24-hour external loop recording, exercise ECG, injected cardiac MRI, And specifically for research purposes : prolongation of the MRI examination (4D flow sequence) and a blood collection.

These patients will undergo at the inclusion and 36 months after the inclusion : According to recommendations : echocardiography, 24-hour external loop recording, exercise ECG, injected cardiac MRI, And specifically for research purposes : prolongation of the MRI examination (4D flow sequence) and a blood collection.

These patients will undergo at the inclusion and 36 months after the inclusion : According to recommendations : echocardiography, 24-hour external loop recording, exercise ECG, injected cardiac MRI, And specifically for research purposes : prolongation of the MRI examination (4D flow sequence) and a blood collection.

Outcomes

Primary Outcome Measures

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
Presence of ventricular arrythmia (fibrillation or tachycardia, extrasystoles)
Occurrence of any ventricular arrythmia on external loop recording or exercise ECG

Secondary Outcome Measures

Full Information

First Posted
April 16, 2021
Last Updated
August 5, 2022
Sponsor
Central Hospital, Nancy, France
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1. Study Identification

Unique Protocol Identification Number
NCT04852731
Brief Title
STretch and Myocardial Characterization in Arrythmogenic Mitral Valve Prolapse-2
Acronym
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2022
Overall Recruitment Status
Recruiting
Study Start Date
August 30, 2021 (Actual)
Primary Completion Date
July 1, 2027 (Anticipated)
Study Completion Date
July 1, 2027 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Central Hospital, Nancy, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Mitral Valve Prolapse

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
280 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Group A (a) : patients without mitral regurgitation without ventricular extrasystole (≤10/hour)
Arm Type
Experimental
Arm Description
These patients will undergo at the inclusion and 36 months after the inclusion : According to recommendations : echocardiography, 24-hour external loop recording and exercise ECG, And specifically for research purposes : injected cardiac MRI and a blood collection.
Arm Title
Group A (b) : patients without mitral regurgitation with ventricular extrasystole (>10/hour)
Arm Type
Experimental
Arm Description
These patients will undergo at the inclusion and 36 months after the inclusion : According to recommendations : echocardiography, 24-hour external loop recording, exercise ECG, injected cardiac MRI, And specifically for research purposes : prolongation of the MRI examination (4D flow sequence) and a blood collection.
Arm Title
Group B : patients with Mitral valve prolapse with trivial mitral regurgitation
Arm Type
Experimental
Arm Description
These patients will undergo at the inclusion and 36 months after the inclusion : According to recommendations : echocardiography, 24-hour external loop recording, exercise ECG, injected cardiac MRI, And specifically for research purposes : prolongation of the MRI examination (4D flow sequence) and a blood collection.
Arm Title
Group C : patients with Mitral valve prolapse with moderate or mild mitral regurgitation
Arm Type
Experimental
Arm Description
These patients will undergo at the inclusion and 36 months after the inclusion : According to recommendations : echocardiography, 24-hour external loop recording, exercise ECG, injected cardiac MRI, And specifically for research purposes : prolongation of the MRI examination (4D flow sequence) and a blood collection.
Arm Title
Group D : patients with asymptomatic Mitral valve prolapse with severe mitral regurgitation
Arm Type
Experimental
Arm Description
These patients will undergo at the inclusion and 36 months after the inclusion : According to recommendations : echocardiography, 24-hour external loop recording, exercise ECG, injected cardiac MRI, And specifically for research purposes : prolongation of the MRI examination (4D flow sequence) and a blood collection.
Intervention Type
Procedure
Intervention Name(s)
Cardiac MRI
Intervention Description
Injected cardiac MRI
Intervention Type
Other
Intervention Name(s)
Blood collection
Intervention Description
Blood collection (including genetics at the inclusion visit)
Intervention Type
Procedure
Intervention Name(s)
Prolongation of the MRI examination
Intervention Description
Prolongation of the MRI examination (4D flow sequence ; about 10 min)
Primary Outcome Measure Information:
Title
Presence of ventricular remodelling
Description
Variation of at least 10% of the telestolic volume observed at 3 years on cardiac MRI compared to the initial cardiac MRI
Time Frame
3 years
Title
Presence of ventricular arrythmia (fibrillation or tachycardia, extrasystoles)
Description
Occurrence of any ventricular arrythmia on external loop recording or exercise ECG
Time Frame
3 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Facility Information:
Facility Name
Nancy University Hospital
City
Vandœuvre-lès-Nancy
ZIP/Postal Code
54511
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Marc SELLAL, MD
Phone
+33383153256
Email
jm.sellal@chru-nancy.fr
First Name & Middle Initial & Last Name & Degree
Olivier HUTTIN, MD
Phone
+33383157355
Email
o.huttin@chru-nancy.fr

12. IPD Sharing Statement

Plan to Share IPD
No

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STretch and Myocardial Characterization in Arrythmogenic Mitral Valve Prolapse-2

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