NCT03096119

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
1,462

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2017

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2017

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 30, 2017

Completed
7 days until next milestone

Study Start

First participant enrolled

April 6, 2017

Completed
12 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 31, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

March 31, 2018

Completed
Last Updated

April 17, 2018

Status Verified

April 1, 2018

Enrollment Period

12 months

First QC Date

March 23, 2017

Last Update Submit

April 15, 2018

Conditions

Keywords

blood pressure monitoring, homeAsia

Outcome Measures

Primary Outcomes (1)

  • 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

    7 days or more blood pressure measurement

Interventions

We ask participants to measure their home blood pressure 7 days or more.

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Jichi Medical University

Tochigi, Japan

Location

Related Publications (1)

  • 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.

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Kazuomi Kario, MD, PhD

    Jichi Medical University School of Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor & Chairman

Study Record Dates

First Submitted

March 23, 2017

First Posted

March 30, 2017

Study Start

April 6, 2017

Primary Completion

March 31, 2018

Study Completion

March 31, 2018

Last Updated

April 17, 2018

Record last verified: 2018-04

Data Sharing

IPD Sharing
Will not share

Locations