UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Observational study for home BP using home BP telemonitoring system
Title of the study (Brief title)	Observational study verifying real home BP (Real BP study)
Region	Japan

Condition
Condition	Hypertensive subjects (office systolic BP over 140 mmHg or office diastolic BP over 90 mmHg, or treated hypertension) or subjects being suspected hypertension over 20 years old.
Classification by specialty	Cardiology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To consider home BP related factors and to establish effective use of home BP monitoring
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	A meaning of the outlier of home BP
Key secondary outcomes	1. The relationship between the markers of target organ damage and home BP (morning BP, evening BP, the average of morning and evening BP, the difference between morning and evening BP) 2. The relationship between the markers of target organ damage and short-term home BP variability and day-by-day home BP variability 3. The relationship between the markers of depression and cognitive dysfunction and home BP (morning BP, evening BP, the average of morning and evening BP, the difference between morning and evening BP) 4. The correlation between home BP and physical activity 5. The correlation between home BP and the estimated salt intake amount 6. The relationship between urine sodium and potassium level and home BP and the markers of target organ damage

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	Hypertensive subjects (office systolic BP over 140 mmHg or office diastolic BP over 90 mmHg, or treated hypertension) or subjects being suspected hypertension over 20 years old.
Key exclusion criteria	1. Subjects not living the municipality where hospitals exist 2. Subjects with secondary hypertension 3. Subjects with ischemic heart disease, stroke, aortic dissection, chronic artery obstruction and heart failure with hospitalization less than 6 months 4. Subjects with hemodialysis 5. Subjects with atrial fibrillation and multiple ventricular contraction 6. Subjects whom we cannot obtain informed consent 7. Subjects who cannot measure home BP or fill out a questionnaire by oneself 8. Subjects who cannot walk 9. Subjects for whom the attending doctor considered he or she is not appropriate for the study
Target sample size	250

Research contact person
Name of lead principal investigator	Eguchi Kazuo
Organization	Jichi Medical University
Division name	Cardiology
Address	3311-1 Yakushiji, Shimotsuke-shi, Tochigi
TEL	0285-58-7344
Email	ke112@jichi.ac.jp

Public contact
Name of contact person	Eguchi Kazuo
Organization	Jichi Medical University
Division name	Cardiology
Address	3311-1 Yakushiji, Shimotsuke-shi, Tochigi
TEL	0285-58-7344
Homepage URL
Email	ke112@jichi.ac.jp

Sponsor
Institute	Jichi Medical University
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

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

Other administrative information
Date of disclosure of the study information	2015 Year 11 Month 02 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 29 Day
Anticipated trial start date	2015 Year 11 Month 02 Day
Last follow-up date
Date of closure to data entry	2017 Year 03 Month 31 Day
Date trial data considered complete	2017 Year 03 Month 31 Day
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information	Design: Observational study Recruitment method for subjects: Patients who go to the medical institutions concerned from November 2015 to March 2017 and meet all inclusion criteria are recruited Measuring items: Characteristics of patients, office BP, home BP, physical activity, urine electrolytes, augmentation index, left ventricular mass, aortic diameter, intima media thickness, brachial ankle pulse wave velocity

Management information
Registered date	2015 Year 10 Month 31 Day
Last modified on	2017 Year 05 Month 04 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000022561