UMIN-CTR Clinical Trial

Public title

Study of BP Variability and Reactivity measured by new ICT-based BP monitoring system to anticipate future CV events

Acronym

Study of BP Variability and Reactivity measured by new ICT-based BP monitoring system to anticipate future CV events (ANTICIPATE)

Scientific Title

Study of BP Variability and Reactivity measured by new ICT-based BP monitoring system to anticipate future CV events

Scientific Title:Acronym

Study of BP Variability and Reactivity measured by new ICT-based BP monitoring system to anticipate future CV events (ANTICIPATE)

Region

Japan

Condition

Patient with at least one of the following cardiovascular risk factor:
1. Diabetes mellitus
2. Dyslipidemia
3. Hypertension
4. Current smoking
5. Renal disease (eGFR <= 60 or positive proteinuria)
6. Atrial fibrillation
7. Metabolic syndrome
8. Chronic obstructive pulmonary disease
9. Sleep apnea syndrome
10. Age>=75

Classification by specialty

Cardiology

Classification by malignancy

Others

Genomic information

NO

Narrative objectives1

This study aimed to clarify the relationship between the individual risk of CV events and blood pressure variability taking into account individual facts in environment (temperature and atmospheric pressure) and lifestyle (activity and salt intake).

Basic objectives2

Efficacy

Basic objectives -Others

Trial characteristics_1

Trial characteristics_2

Developmental phase

Primary outcomes

Onset of Major cardiovascular events*
*Major cardiovascular events; total death, cardiovascular death, sudden death, ischaemic heart disease (acute myocardial infarction, angina pectoris), cerebrovascular disease (cerebral infarction, cerebral embolism, cerebral hemorrhage, subarachnoid hemorrhage), and hospitalization by heart failure

Key secondary outcomes

New onset of occlusive arteriosclerosis, aortic dissection, diabetes mellitus, chronic dialysis, atrial fibrillation, and hypertension.

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

Patient with at least one of the following cardiovascular risk factor:
1. Diabetes mellitus
2. Dyslipidemia
3. Hypertension
4. Current smoking
5. Renal disease (eGFR <= 60 or positive proteinuria)
6. Atrial fibrillation
7. Metabolic syndrome
8. Chronic obstructive pulmonary disease
9. Sleep apnea syndrome
10. Age>=75

Key exclusion criteria

1. Patients who have history of ischemic heart disease, erebrovascular disease (exclude asymptomatic and transient), occlusive arteriosclerosis, aortic dissection, and hospitalization for heart failure within 6 months before consent.
2. Patients with chronic renal failure in haemodialysis
3. Other seriously ill patients (e.g. end stage of cancer, active connective tissue disease)

Target sample size

500

Name of lead principal investigator

1st name
Middle name
Last name	Kazuomi Kario

Organization

Jichi Medical University of Medicine

Division name

Division of Cardiovascular Medicine, Department of Medicine

Zip code

Address

3311-1, Yakushiji, Shimotsuke, Tochigi, Japan

TEL

0285-58-7538

Email

kkario@jichi.ac.jp

Name of contact person

1st name
Middle name
Last name	Kazuomi Kario

Organization

Jichi Medical University of Medicine

Division name

Division of Cardiovascular Medicine, Department of Medicine

Zip code

Address

3311-1, Yakushiji, Shimotsuke, Tochigi, Japan

TEL

0285-58-7538

Homepage URL

Email

kkario@jichi.ac.jp

Institute

Jichi Medical University of Medicine

Institute

Department

Personal name

Organization

Impulsing Paradigm Change through Disruptive Technologies Program (ImPACT)

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan

Co-sponsor

Name of secondary funder(s)

Organization

Address

Tel

Email

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）、南三陸病院（宮城県）、東吾妻診療所（群馬県）

Date of disclosure of the study information

2016

Year

11

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

Completed

Date of protocol fixation

2016

Year

07

Month

20

Day

Date of IRB

2016

Year

07

Month

20

Day

Anticipated trial start date

2016

Year

08

Month

22

Day

Last follow-up date

2019

Year

03

Month

31

Day

Date of closure to data entry

Date trial data considered complete

Date analysis concluded

Other related information

The investigators will collect the following information from August 2016 through March 2019:
1)blood pressure
2)environment (temperature and atmospheric pressure)
3)lifestyle (activity and salt intake)

Registered date

2016

Year

11

Month

15

Day

Last modified on

2019

Year

04

Month

15

Day

Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000028585