UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000040939 |
|---|---|
| Receipt number | 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 | 2021/08/16 09:46:21 |
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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
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
kkario@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University School of Medicine
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046708
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