UMIN-CTR Clinical Trial

Basic information
Public title	Evaluation of ambulatory blood pressure values measured by new wearable wrist-type blood pressure monitoring device
Acronym	A study to evaluate the ambulatory blood pressure values measured by wearable monitoring device
Scientific Title	Evaluation of ambulatory blood pressure values measured by new wearable wrist-type blood pressure monitoring device
Scientific Title:Acronym	A study to evaluate the ambulatory blood pressure values measured by wearable monitoring device
Region	Japan

Condition
Condition	Patients with suspected or confirmed hypertension
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To compare the ambulatory blood pressure values measured by wearable wrist-type blood pressure monitoring (WBPM) device and ambulatory blood pressure monitoring (ABPM) device
Basic objectives2	Others
Basic objectives -Others	Agreement
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Mean error and standard deviation of systolic blood pressure measured by WBPM and ABPM at the same measurement point
Key secondary outcomes	Mean error and standard deviation of diastolic blood pressure measured by WBPM and ABPM at the same measurement point

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	Prevention
Type of intervention	Device,equipment
Interventions/Control_1	Both of the ABPM device and the WBPM device are placed on non-dominant arm. Ambulatory blood pressure measurement with 30 minutes' interval for 24 hours are performed by ABPM. Patients are asked to measure blood pressure by WBPM (more than 10 times during 24 hours) just after ABPM interval measurement.
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	1) Patients who are scheduled to undergo ambulatory blood pressure monitoring in their clinical practice 2) wrist circumference: 16-19cm 3) Age => 20
Key exclusion criteria	Patients who are considered not eligible for the study by the investigators
Target sample size	50

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

Public contact
Name of contact person	1st name Kazuomi Middle name Last name Kario
Organization	Jichi Medical University School of Medicine
Division name	Division of cardiovascular medicine, Depertment of medicine
Zip code	329-0498
Address	3311-1 Yakushiji, Shimotsuke, Tochigi, JAPAN
TEL	0285-58-7344
Homepage URL
Email	kkario@jichi.ac.jp

Sponsor
Institute	Jichi Medical University School of Medicine
Institute
Department

Funding Source
Organization	Department of Sleep and Circadian Cardiology, Jichi Medical University School of Medicine
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization	Jichi Medical University
Address	3311-1 Yakushiji, Shimotsuke, Tochigi, JAPAN
Tel	0285-58-7344
Email	kkario@jichi.ac.jp

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	2019 Year 05 Month 20 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	Completed
Date of protocol fixation	2019 Year 03 Month 25 Day
Date of IRB	2019 Year 03 Month 25 Day
Anticipated trial start date	2019 Year 06 Month 10 Day
Last follow-up date	2019 Year 10 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date	2019 Year 05 Month 09 Day
Last modified on	2020 Year 04 Month 03 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000041806