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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000025357
Receipt No. R000029190
Scientific Title Risk stratification for sudden cardiac death in patients with mitral valve prolapse, based on cardiac imaging
Date of disclosure of the study information 2020/07/31
Last modified on 2018/01/02

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Basic information
Public title Risk stratification for sudden cardiac death in patients with mitral valve prolapse, based on cardiac imaging
Acronym Risk stratification for sudden cardiac death in mitral valve prolapse
Scientific Title Risk stratification for sudden cardiac death in patients with mitral valve prolapse, based on cardiac imaging
Scientific Title:Acronym Risk stratification for sudden cardiac death in mitral valve prolapse
Region
Europe

Condition
Condition Mitral valve prolapse
Classification by specialty
Cardiology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Sudden cardiac death is an important health issue, still affection 1 on 1000 persons per year. Mitral valve prolapse has since long been associated with sudden cardiac death in young people. The pathophysiological link between the presence of mitral valve prolapse and the occurrence of sudden cardiac death is not yet fully understood. Furthermore, guidelines for the assessment of the arrhythmic risk in patients with mitral valve prolapse are lacking.
In this study, the arrhythmic profile of patients with mitral valve prolapse will be assessed based on repeated Holter monitoring recordings. Transthoracic echocardiography and cardiac magnetic resonance will be performed in order to detect subtle structural and mechanical changes. Blood samples will be collected to look for potential biomarkers. Electrophysiological data and respectively imaging features and biological data will be correlated. In this way, new predictors for the risk of severe ventricular arrhythmias in patients with mitral valve prolapse can be identified. This will also allow to further elucidate the pathophysiological link between mitral valve prolapse and the occurence of severe arrhythmias.
Basic objectives2 Others
Basic objectives -Others Diagnostic
Trial characteristics_1 Exploratory
Trial characteristics_2 Explanatory
Developmental phase Not applicable

Assessment
Primary outcomes (Aborted) sudden cardiac death or severe ventricular arrhythmias. After 2 years.
Key secondary outcomes Premature ventricular complexes

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Diagnosis
Type of intervention
Other
Interventions/Control_1 Baseline cardiac magnetic resonance and echocardiography. ECG and Holter monitoring every 6 months.
Interventions/Control_2
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

Eligibility
Age-lower limit
18 years-old <=
Age-upper limit
100 years-old >
Gender Male and Female
Key inclusion criteria Diagnosis of mitral valve prolapse or Barlow's disease on echocardiography
Ability to give informed consent
Key exclusion criteria Severe valvular disease or heart disease from a different origine
Severe renal failure
Life expectancy of less than one year
Inability to give informed consent
Target sample size 120

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Esther Scheirlynck
Organization Universitair ziekenhuis Brussel
Division name Cardiology department
Zip code
Address Laarbeeklaan 101, 1090 Jette
TEL 00324776009
Email escheirl@vub.ac.be

Public contact
Name of contact person
1st name
Middle name
Last name Esther Scheirlynck
Organization Universitair ziekenhuis Brussel
Division name Cardiology department
Zip code
Address Laarbeeklaan 101, 1090 Jette
TEL 00324776009
Homepage URL
Email escheirl@vub.ac.be

Sponsor
Institute Cardiology department UZ Brussel, under supervision of Bernard Cosyns
Institute
Department

Funding Source
Organization Cardiology department UZ Brussel, under supervision of Bernard Cosyns
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions University hospital (Brussels)

Other administrative information
Date of disclosure of the study information
2020 Year 07 Month 31 Day

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status Preinitiation
Date of protocol fixation
2016 Year 12 Month 31 Day
Date of IRB
Anticipated trial start date
2017 Year 01 Month 02 Day
Last follow-up date
2017 Year 12 Month 22 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2016 Year 12 Month 21 Day
Last modified on
2018 Year 01 Month 02 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029190

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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