UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000036689
Receipt No. R000041806
Scientific Title Evaluation of ambulatory blood pressure values measured by new wearable wrist-type blood pressure monitoring device
Date of disclosure of the study information 2019/05/20
Last modified on 2019/09/25

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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 Enrolling by invitation
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
2019 Year 09 Month 25 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.