UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Risk stratification in Brugada syndrome: analysis of unipolar Holter electrocardiogram after Pilsicainide provocation.
Title of the study (Brief title)	Unipolar Holter electrocardiogram after Pilsicainide provocation in Brugada syndrome.
Region	Japan

Condition
Condition	Brugada syndrome
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To clarify the prognostic value for fatal ventricular arrhythmias using unipolar Holter ECG (Fukuda Electronics Co., Ltd.: FM - 980) after pilsicainide provocation.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To evaluate late potentials [LP: filtered QRS(f-QRS), duration of low-amplitude signals :LAS40 and root mean square voltage:RMS40], ST amplitude(mV), QTc interval, J amplitude and T-wave alternans (TWA) in leads V2 and V5 on unipolar Holter electrocardiogram after the plisicainide provocation.
Key secondary outcomes

Base
Study type	Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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	20 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Consecutive patients who with Brugada syndrome
Key exclusion criteria	1) Patients with bundle branch block. 2)Patients with left ventricular dysfunction and/or structural heart diseases. 3) Patients who have an invasive therapy for other disease. 4) Patients who cannot undergo Holter ECG. 5) Patients who rejected the inclusion in this study.
Target sample size	50

Research contact person
Name of lead principal investigator	Masahiko Takagi
Organization	Kansai Medical University
Division name	Department of Medicine 2
Address	10-15 Fumizono-cho, Moriguchi, Osaka
TEL	(06)6992-1001
Email	takagims@takii.kmu.ac.jp

Public contact
Name of contact person	Masahiko Takagi
Organization	Kansai Medical University
Division name	Department of Medicine 2
Address	10-15 Fumizono-cho, Moriguchi, Osaka
TEL	(06)6992-1001
Homepage URL
Email	takagims@takii.kmu.ac.jp

Sponsor
Institute	Department of Medicine 2 Kansai Medical University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
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	関西医科大学総合医療センター（大阪府）/ Kansai Medical University Medical Center

Other administrative information
Date of disclosure of the study information	2019 Year 01 Month 12 Day

Progress
Recruitment status	Preinitiation
Date of protocol fixation	2018 Year 10 Month 02 Day
Anticipated trial start date	2018 Year 10 Month 02 Day
Last follow-up date
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	Prospective study. We'll enroll the patients with Brugada-type ECG from IRB approval to Mar. 2023. We'll perform unipolar Holter ECG after Pilsicainide provocation and identify the prognostic risk factors by evaluating late potentials, ST amplitue, dQTc interva, J wave amplitude and T-wave alternans (TWA).

Management information
Registered date	2019 Year 01 Month 12 Day
Last modified on	2019 Year 01 Month 12 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000040480