HypertensionAsia BP@HomeNCT03096119
A Study to Define the Distribution of Type of Hypertension in Asia by Blood Pressure Monitoring at Home (Asia BP@Home)
An observational study of Hypertension, run by Jichi Medical University at 1 site in Japan.
Trial summary
Blood pressure variability (BPV) is being increasingly recognized as an important influence on hypertension outcomes as well as a risk factor for other cardiovascular (CV) events. However, in Asia there is a current lack of awareness of BPV and its significance on patient outcomes. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- home blood pressure measurement
- How many people
- 1,462 participants
- Where
- 1 siteJapan
- Study dates
- 6 Apr 2017to 31 Mar 2018
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Inclusion criteria: 1. Age >= 20 years 2. Subjects with stable medication (> 3 months) diagnosed as hypertension 3. Asian 4. Subjects have been thoroughly informed about this registry and signed an Informed Consent Form.
Who may be able to join
- Age >= 20 years
- Subjects with stable medication (> 3 months) diagnosed as hypertension
- Asian
- Subjects have been thoroughly informed about this registry and signed an Informed Consent Form.
Who cannot join
- -
Trial locations and contacts
1 site in 1 country.
About this study
Blood pressure variability (BPV) is being increasingly recognized as an important influence on hypertension outcomes as well as a risk factor for other cardiovascular (CV) events. However, in Asia there is a current lack of awareness of BPV and its significance on patient outcomes. Furthermore, there is ongoing debate on the role of home blood pressure (HBP) monitoring in managing hypertension patients and uncertainty on how best to integrate it into clinical practice.
Therefore, we conduct Asia BP@Home study to assess HBP control status in each Asian country and develop an Asian consensus and Asia-specific treatment for hypertension.
Read the detailed description
Blood pressure variability (BPV) is being increasingly recognized as an important influence on hypertension outcomes as well as a risk factor for other cardiovascular (CV) events. However, in Asia there is a current lack of awareness of BPV and its significance on patient outcomes. Furthermore, there is ongoing debate on the role of home blood pressure (HBP) monitoring in managing hypertension patients and uncertainty on how best to integrate it into clinical practice.
The main purpose of this study is to:
- Assess HBP control status in each Asian country
- Develop an Asian consensus and Asia-specific treatment for hypertension
- Improve the management of hypertension in Asia by encouraging patients to monitor HBP
- Conditions
- Hypertension
- Being tested
- home blood pressure measurement
- Keywords
- blood pressure monitoring, home, Asia
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
home blood pressure measurementOther
We ask participants to measure their home blood pressure 7 days or more.
What is being measured
The primary outcome is the main question the study is designed to answer.
Distribution rate based on the home BP of the patients.
Distribution rate based on the home BP of the patients who are defined as:
- Masked morning hypertension
- White-coat hypertension
- Poorly controlled hypertension
- Well controlled hypertension
Measured: 7 days or more blood pressure measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Mar 2017
- Study start6 Apr 2017
- Primary completion31 Mar 2018
- Study completion31 Mar 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,462 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jichi Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kazuomi Kario, Jichi Medical University
- Investigators
- Kazuomi Kario, MD, PhD, Principal investigator, Jichi Medical University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03096119
- Sponsor's protocol ID
- RinA16-080
- Acronym
- Asia BP@Home
- Status last verified
- Apr 2018
- First submitted
- 23 Mar 2017
- Last updated
- 17 Apr 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Chia YC, Kario K, Tomitani N, Park S, Shin J, Turana Y, Tay JC, Buranakitjaroen P, Chen CH, Hoshide S, Nailes J, Minh HV, Siddique S, Sison J, Soenarta AA, Sogunuru GP, Sukonthasarn A, Teo BW, Verma N, Zhang Y, Wang TD, Wang JG. Comparison of day-to-day blood pressure variability in hypertensive patients with type 2 diabetes mellitus to those without diabetes: Asia BP@Home Study. J Clin Hypertens (Greenwich). 2020 Mar;22(3):407-414. doi: 10.1111/jch.13731. Epub 2019 Dec 31.
PubMed 31891447
Study at a glance
From the registry record, last updated by the sponsor on 17 Apr 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study to Define the Distribution of Type of Hypertension in Asia by Blood Pressure Monitoring at Home (Asia BP@Home)
- ClinicalTrials.gov ID
- NCT03096119
- Acronym / sponsor ID
- Asia BP@Home / RinA16-080
- Conditions
- Hypertension
- Keywords
- blood pressure monitoring, home, Asia
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,462 participants (actual)
- Lead sponsor
- Jichi Medical UniversityUniversity, hospital or other
- Study start
- 6 Apr 2017 (actual)
- Primary completion
- 31 Mar 2018 (actual)
- Study completion
- 31 Mar 2018 (actual)
- First posted
- 30 Mar 2017 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Blood pressure variability (BPV) is being increasingly recognized as an important influence on hypertension outcomes as well as a risk factor for other cardiovascular (CV) events. However, in Asia there is a current lack of awareness of BPV and its significance on patient outcomes. Furthermore, there is ongoing debate on the role of home blood pressure (HBP) monitoring in managing hypertension patients and uncertainty on how best to integrate it into clinical practice.
Therefore, we conduct Asia BP@Home study to assess HBP control status in each Asian country and develop an Asian consensus and Asia-specific treatment for hypertension.
Detailed description
Blood pressure variability (BPV) is being increasingly recognized as an important influence on hypertension outcomes as well as a risk factor for other cardiovascular (CV) events. However, in Asia there is a current lack of awareness of BPV and its significance on patient outcomes. Furthermore, there is ongoing debate on the role of home blood pressure (HBP) monitoring in managing hypertension patients and uncertainty on how best to integrate it into clinical practice.
The main purpose of this study is to:
- Assess HBP control status in each Asian country
- Develop an Asian consensus and Asia-specific treatment for hypertension
- Improve the management of hypertension in Asia by encouraging patients to monitor HBP
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Inclusion criteria: 1. Age >= 20 years 2. Subjects with stable medication (> 3 months) diagnosed as hypertension 3. Asian 4. Subjects have been thoroughly informed about this registry and signed an Informed Consent Form.
Key inclusion criteria (4 listed)
- Age >= 20 years
- Subjects with stable medication (> 3 months) diagnosed as hypertension
- Asian
- Subjects have been thoroughly informed about this registry and signed an Informed Consent Form.
Key exclusion criteria (1 listed)
- -
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| home blood pressure measurementWe ask participants to measure their home blood pressure 7 days or more. | Other | – |
Primary outcome
Distribution rate based on the home BP of the patients.
Time frame: 7 days or more blood pressure measurement
Distribution rate based on the home BP of the patients who are defined as: * Masked morning hypertension * White-coat hypertension * Poorly controlled hypertension * Well controlled hypertension
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Apr 2018.
- Derived from this study: PubMed 31891447Chia YC, Kario K, Tomitani N, Park S, Shin J, Turana Y, Tay JC, Buranakitjaroen P, Chen CH, Hoshide S, Nailes J, Minh HV, Siddique S, Sison J, Soenarta AA, Sogunuru GP, Sukonthasarn A, Teo BW, Verma N, Zhang Y, Wang TD, Wang JG. Comparison of day-to-day blood pressure variability in hypertensive patients with type 2 diabetes mellitus to those without diabetes: Asia BP@Home Study. J Clin Hypertens (Greenwich). 2020 Mar;22(3):407-414. doi: 10.1111/jch.13731. Epub 2019 Dec 31.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kazuomi Kario, MD, PhD principal investigator
Jichi Medical University School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension, run by Jichi Medical University at 1 site in Japan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Apr 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Japan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Distribution rate based on the home BP of the patients. (time frame: 7 days or more blood pressure measurement). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03096119, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Apr 2018.