UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Risk stratification for sudden cardiac death in patients with mitral valve prolapse, based on cardiac imaging
Title of the study (Brief title)	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	Esther Scheirlynck
Organization	Universitair ziekenhuis Brussel
Division name	Cardiology department
Address	Laarbeeklaan 101, 1090 Jette
TEL	00324776009
Email	escheirl@vub.ac.be

Public contact
Name of contact person	Esther Scheirlynck
Organization	Universitair ziekenhuis Brussel
Division name	Cardiology department
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)

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

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2016 Year 12 Month 31 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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/icdr_e/ctr_view.cgi?recptno=R000029190