UMIN-CTR Clinical Trial

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

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

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

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

Study type

Observational

Basic design

Randomization

Randomization unit

Blinding

Control

Stratification

Dynamic allocation

Institution consideration

Blocking

Concealment

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

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

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

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

Institute

Jichi Medical University School of Medicine

Institute

Department

Personal name

Organization

Super Circulation Monitoring with High Technology R & D Center

Organization

Division

Category of Funding Organization

Other

Nationality of Funding Organization

Co-sponsor

OMRON HEALTHCARE Co., Ltd.

Name of secondary funder(s)

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

NO

Study ID_1

Org. issuing International ID_1

Study ID_2

Org. issuing International ID_2

IND to MHLW

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）

Date of disclosure of the study information

2021

Year

03

Month

15

Day

URL releasing protocol

Publication of results

Unpublished

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

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 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

Registered date

2021

Year

03

Month

12

Day

Last modified on

2021

Year

11

Month

22

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000049781