UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Verification and improvement of detection accuracy for atrial fibrillation from IHB (Irregular heart beat) measured by home blood pressure monitoring
Title of the study (Brief title)	Verification and improvement of detection accuracy for atrial fibrillation from IHB (Irregular heart beat) measured by home blood pressure monitoring (%IHB)
Region	Japan

Condition
Condition	Chronic atrial fibrillation
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To explore early detecting methods for atrial fibrillation which is a high risk factor for cardiovascular events by using home blood pressure monitoring
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Detection accuracy of atrial fibrillation from IHB (Irregular heart beat) measured by home blood pressure monitoring
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	-Patients with chronic atrial fibrillation -Age >=20 years old
Key exclusion criteria	Considered not eligible for the study by the investigator
Target sample size	100

Research contact person
Name of lead principal investigator	Kazuomi Kario
Organization	Jichi Medical University School of Medicine
Division name	Division of cardiovascular Medicine, Department of Medicine
Address	3311-1 Yakushiji, Shimotsuke, Tochigi Japan 329-0498
TEL	0285-58-7344
Email	kkario@jichi.ac.jp

Public contact
Name of contact person	Kazuomi Kario
Organization	Jichi Medical University School of Medicine
Division name	Division of cardiovascular Medicine, Department of Medicine
Address	3311-1 Yakushiji, Shimotsuke, Tochigi Japan 329-0498
TEL	0285-58-7344
Homepage URL
Email	kkario@jichi.ac.jp

Sponsor
Institute	Jichi Medical University School of Medicine
Institute
Department

Funding Source
Organization	Jichi Medical University School of Medicine
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

Other administrative information
Date of disclosure of the study information	2016 Year 12 Month 01 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 12 Month 01 Day
Anticipated trial start date	2016 Year 02 Month 25 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	Published
URL releasing results
Results
Other related information	This study validate the IHB detection accuracy of the home blood pressure monitoring by comparing electrocardiogram

Management information
Registered date	2016 Year 11 Month 30 Day
Last modified on	2019 Year 01 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000028841