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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040939
Receipt No. R000046708
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
Date of disclosure of the study information 2020/07/01
Last modified on 2020/06/26

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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 Preinitiation
Date of protocol fixation
2020 Year 06 Month 24 Day
Date of IRB
Anticipated trial start date
2020 Year 07 Month 01 Day
Last follow-up date
2021 Year 12 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
2020 Year 06 Month 29 Day
Last modified on
2020 Year 06 Month 26 Day


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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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