A Study to Define the Distribution of Type of Hypertension in Asia by Blood Pressure Monitoring at Home (Asia BP@Home) (Asia BP@Home)

April 15, 2018 updated by: Kazuomi Kario, Jichi Medical University

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Actual)

1462

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Japan
      • Tochigi, Japan
        • Jichi Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

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.

Description

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.

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
7 days or more blood pressure measurement

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Jichi Medical University

Investigators

  • Principal Investigator: Kazuomi Kario, MD, PhD, Jichi Medical University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 6, 2017

Primary Completion (Actual)

March 31, 2018

Study Completion (Actual)

March 31, 2018

Study Registration Dates

First Submitted

March 23, 2017

First Submitted That Met QC Criteria

March 23, 2017

First Posted (Actual)

March 30, 2017

Study Record Updates

Last Update Posted (Actual)

April 17, 2018

Last Update Submitted That Met QC Criteria

April 15, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • RinA16-080

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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