UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000019582 |
|---|---|
| Receipt number | R000022561 |
| Scientific Title | Observational study for home BP using home BP telemonitoring system |
| Date of disclosure of the study information | 2015/11/02 |
| Last modified on | 2017/05/04 00:55:38 |
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Basic information
Public title
Observational study for home BP using home BP telemonitoring system
Acronym
Observational study verifying real home BP (Real BP study)
Scientific Title
Observational study for home BP using home BP telemonitoring system
Scientific Title:Acronym
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
| 1st name | |
| Middle name | |
| Last name | Eguchi Kazuo |
Organization
Jichi Medical University
Division name
Cardiology
Zip code
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi
TEL
0285-58-7344
ke112@jichi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Eguchi Kazuo |
Organization
Jichi Medical University
Division name
Cardiology
Zip code
Address
3311-1 Yakushiji, Shimotsuke-shi, Tochigi
TEL
0285-58-7344
Homepage URL
ke112@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University
Institute
Department
Personal name
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)
IRB Contact (For public release)
Organization
Address
Tel
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 |
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
| 2015 | Year | 10 | Month | 29 | Day |
Date of IRB
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
Other
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000022561
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
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| Registered date | File name |
