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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000043599
Receipt No. R000049781
Scientific Title Wrist ICT-Based Sleep and CircaDian BlOod Pressure Monitoring Program - Night blood pressure registry: [WISDOM-Night Registry]
Date of disclosure of the study information 2021/03/15
Last modified on 2021/11/22

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Basic information
Public title Wrist ICT-Based Sleep and CircaDian BlOod Pressure Monitoring Program
- Night blood pressure registry: [WISDOM-Night Registry]
Acronym WISDOM-Night Registry
Scientific Title Wrist ICT-Based Sleep and CircaDian BlOod Pressure Monitoring Program
- Night blood pressure registry: [WISDOM-Night Registry]
Scientific Title:Acronym WISDOM-Night Registry
Region
Japan

Condition
Condition myocardial infarction, angina pectoris, heart failure, cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage, aortic dissection, peripheral arterial disease, hypertension, diabetes mellitus, hyperlipidemia, atrial fibrillation, chronic kidney disease, chronic obstructive pulmonary disease, sleep apnea syndrome, hyperuricemia
Classification by specialty
Cardiology Endocrinology and Metabolism Nephrology
Neurology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the relationship between nighttime blood pressure (BP) measured by a wrist-type home BP monitoring device for 7 days in daily life and cardiovascular events.
To examine the best timing of nighttimeBP measurement schedule and the nighttime BPindex, which could predict future cardiovascular events.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Relationship between the average of wrist-measured nighttimeblood pressure values and the onset of major cardiovascular events
Major cardiovascular events: total death, cardiovascular death, sudden death, ischemic heart disease (acute myocardial infarction, angina pectoris), cerebrovascular disease (cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage), aortic dissection, and hospitalization by heart failure, enhanced treatment of worsening heart failure symptoms

Key secondary outcomes 1) Relationship between the average of wrist-measured nighttimeblood pressure values and the onset of the following diseases;
New onset of atrial fibrillation, peripheral arterial disease, deterioration of renal function (including initiation of chronic dialysis), diabetes mellitus, or onset of gout attack
2) Relationship between the mean value of each wrist BP measurement point (2 o'clock, 3 o'clock, 4 o'clock, 4 hours after going to bed, morning, or evening) and the onset of cardiovascular disease
3) Relationship between the wrist BP changes (from baseline to 1-year-later) and the onset of cardiovascular event


Base
Study type Observational

Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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 Patients who meet all the following criteria will be eligible for this study.
1) Patients with at least one history of the following cardiovascular diseases *1 or patients with at least one of the following cardiovascular risk factors *2
2) wrist circumference: 13.5-21.5cm

*1: Cerebrovascular disease (cerebral infarction, cerebral hemorrhage, subarachnoid hemorrhage), myocardial infarction, angina pectoris, aortic dissection, peripheral arterial disease, or heart failure
* 2: Diabetes mellitus, hyperlipidemia, hypertension (hypertension with antihypertensivetreatment or untreated hypertension with office BP>130/80 mmHg), chronic kidney disease (CKD), atrial fibrillation, sleep apnea syndrome, chronic obstructive pulmonary disease, hyperuricemia, or current smoking
Key exclusion criteria Patients who meet the following exclusion criteria:
1) Shift worker (those who are engaged in night shifts more than 3 days a week)
2) Patients who have history of cerebrovascular disease (exclude asymptomatic and transient) within 6 months before enrollment.
3) Patients with chronic renal failure on hemodialysis
4) Other serious diseases (cancer, collagen disease, etc.). However, patients who have been confirmed to be in remission or cure of cancer can be registered.
5) Patients using a pacemaker
Target sample size 3500

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, Department of Medicine
Zip code 329-0498
Address 3311-1 Yakushiji, Shimotsuke-shi,
TEL 0285-58-7344
Email kkario@jichi.ac.jp

Public contact
Name of contact person
1st name Satoshi
Middle name
Last name Hoshide
Organization Jichi Medical University School of Medicine
Division name Division of Cardiovascular, Medicine, Department of Medicine
Zip code 329-0498
Address 3311-1 Yakushiji, Shimotsuke-shi,
TEL 0285-58-7344
Homepage URL
Email hoshide@jichi.ac.jp

Sponsor
Institute Jichi Medical University School of Medicine
Institute
Department

Funding Source
Organization Super Circulation Monitoring with High Technology R & D Center
Organization
Division
Category of Funding Organization Other
Nationality of Funding Organization

Other related organizations
Co-sponsor OMRON HEALTHCARE Co., Ltd.
Name of secondary funder(s)

IRB Contact (For public release)
Organization Bioethics Committee for Clinical Research, Jichi Medical University Hospital
Address 3311-1 Yakushiji, Shimotsuke-shi,
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 自治医科大学附属病院(栃木県)、鷲谷病院(栃木県)、とちぎメディカルセンターしもつが(栃木県)、南三陸病院(宮城県)、奥田クリニック(東京都)、小椿クリニック(広島県)、旭川医科大学病院(北海道)、留萌市立病院(北海道)、表参道内科眼科(東京都)、横浜呼吸器クリニック(神奈川県)、藤田脳神経外科医院(香川県)、上田内科クリニック(福岡県)、おんが病院(福岡県)


Other administrative information
Date of disclosure of the study information
2021 Year 03 Month 15 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
2021 Year 02 Month 18 Day
Date of IRB
2021 Year 02 Month 18 Day
Anticipated trial start date
2021 Year 03 Month 18 Day
Last follow-up date
2032 Year 03 Month 31 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information [Study methods]
Study patients are asked to measure their BPs at home (morning, evening, and nighttime) for 7 days at the time of baseline and 1-year-later. The information such as the occurrence of cardiovascular events will be collected from the medical record from baseline to 7-year-later (Follow-up period).
During the follow-up period, the following test results and medical record information, if any, performed in the clinical practice will be collected as research data; Blood pressure (Office BP, home BP, and ambulatory BP), Echocardiography, Blood test, Urine test, Vascular function test, InBody, Medication

[Sub-cohort study]
At Jichi Medical University Hospital and Washiya Hospital, patients with hypertension and who agree with participating in the sub-cohort study, will be additionally underwent echocardiography, CAVI, and Inbody examination. In the sub-cohort study, the relationship between wrist-measured nighttime BP and target organ

Management information
Registered date
2021 Year 03 Month 12 Day
Last modified on
2021 Year 11 Month 22 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049781

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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