UMIN-CTR Clinical Trial

Basic information
Public title	To clarify the association between blood pressure measured by a new wearable wrist-type blood pressure monitoring device (WBPM) and left ventricular hypertrophy
Acronym	To clarify the association between blood pressure measured by WBPM and LVH
Scientific Title	To clarify the association between blood pressure measured by a new wearable wrist-type blood pressure monitoring device (WBPM) and left ventricular hypertrophy
Scientific Title:Acronym	To clarify the association between blood pressure measured by WBPM and LVH
Region	Japan

Condition
Condition	Hypertension
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To investigate the relationship between the blood pressure measured by WBPM and the left ventricular hypertrophy (LVH) measured by cardiac MRI (CMR).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2
Developmental phase	Not applicable

Assessment
Primary outcomes	The association between LVM Index measured by CMR and the BP measured by WBPM.
Key secondary outcomes	The association between 1)LVM Index and BP measured by ABPM or office BP. 2)CAVI and BP(WBPM/ABPM/office). 3)LVM index and CAVI. 4)BP (WBPM/ABPM/office) and LVH diagnosed by ECG (Cornell Voltage). 5)Correlation between BP parameters measured by different devices (WBPM/ ABPM/ Office).

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 Behavior,custom
Interventions/Control_1	Patients are asked to measure their BP using WBPM at waking up, before bedtime, daytime( 10:00, 12:00, 14:00, 16:00, 18:00), and anytime when patients think BP has increased at work or at home for about 5 days. To undergo an inspection (cardiac MRI, ABPM, CAVI, ECG) at the hospital.
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	35 years-old <=
Age-upper limit	Not applicable
Gender	Male and Female
Key inclusion criteria	Patients who meet all of the following criteria are included in this study. 1)Office BP=>130mmHg or receiving antihypertensive drugs. 2)Age =<35 at the time of giving their consent 3)Wrist circumference: 16-19cm. 4)It is possible to measure BP on set time at work.
Key exclusion criteria	Patients who meet the following criteria are excluded in this study. 1) Current atrial fibrillation or other significant arrhythmia 2) Any other reason the investigator considers the potential participant unsuitable for the study
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 School of Medicine
Address	3311-1 Yakushiji, Shimotsuke, Tochigi, JAPAN
Tel	0285-58-8933
Email	rinri@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	鷲谷病院(栃木県) Washiya Hospital, Utsunomiya-shi, Tochigi, JAPAN

Other administrative information
Date of disclosure of the study information	2020 Year 07 Month 01 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	2020 Year 06 Month 24 Day
Date of IRB	2020 Year 06 Month 24 Day
Anticipated trial start date	2020 Year 07 Month 01 Day
Last follow-up date	2021 Year 02 Month 08 Day
Date of closure to data entry	2021 Year 05 Month 28 Day
Date trial data considered complete	2021 Year 05 Month 28 Day
Date analysis concluded	2021 Year 05 Month 28 Day

Other
Other related information

Management information
Registered date	2020 Year 06 Month 29 Day
Last modified on	2021 Year 08 Month 16 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046708