ClinicalTrials.gg
CompletedNCT03855605Updated Jul 12, 2021

Diagnosis of Hypertension by Home Blood Pressure Monitoring

An observational study in Hypertension,Essential, Home Blood Pressure and Ambulatory Blood Pressure, sponsored by DongGuk University. Completed at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2021-07-12.

Sponsored by DongGuk University · Observational

Study type
Observational
Model
Case-only
Time perspective
Cross-sectional
Enrollment
470
Ages
20 Years and older
Sex
All
01

Study summary

Home blood pressure measurement has been recommended to use in the diagnosis of hypertension. The investigators have developed diagnostic algorithm of hypertension by using 24-hour and home blood pressure measurement. However, the diagnostic agreement between home blood pressure measurement and 24-hour ambulatory blood pressure measurement is about 70 - 85%. The discrepancy of diagnosis between home blood pressure measurement and 24-hour ambulatory blood pressure is one of the barriers to introduce home blood pressure measurement in the diagnosis of hypertension.

To solve the discrepancy, identifying the characteristic patients showing discrepancy of hypertension diagnosis between home blood pressure measurement and 24-hour ambulatory blood pressure measurement is needed.

The purpose of the present study are (1) to validate the diagnostic algorithm of hypertension by using 24-hour ambulatory blood pressure and home blood pressure measurement the investigators have developed, and (2) to identifying the characteristics of patients showing discrepancy of diagnosis between 24-hour ambulatory blood pressure and home blood pressure measurement, and (3) lastly to improve the diagnostic algorithm of hypertension by using home blood pressure measurement.

02

Conditions studied

  • Hypertension,Essential
  • Home Blood Pressure
  • Ambulatory Blood Pressure
03

In context

Essential Hypertension

478 studies on the registry are indexed under Essential Hypertension; 74 are open to participants now.

This study's enrollment of 470 is below the median of 702 across 70 observational studies indexed under Essential Hypertension.

Browse Essential Hypertension studies →

Lead sponsor

DongGuk University is the lead sponsor of 27 studies on the registry; 1 is open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

At the out-patient clinics, study investigators recruit study participants who have high blood pressure measured by them at the out-patient clinics and adequate for eligibility.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Men and women
  • Patients with high blood pressure measured by doctors at the outpatient office

Exclusion criteria

Exclusion Criteria:

  • Patients taking antihypertensive drugs or blood pressure affecting drugs within 1 month
  • Secondary hypertension
  • Hypertensive emergency and urgency
  • Severe heart failure ( III and IV)
  • Angina with 6 months
  • Myocardial infarction within 6 months
  • Peripheral artery disease within 6 months
  • Significant arrhythmia (i.e. ventricular tachycardia and fibrillation, atrial fibrillation, atrial flutter)
  • Pregnancy
  • Night labor, shift worker
  • Those who are currently participating in other clinical studies
  • Those who have taken other clinical trial drugs within the past month
  • According to the opinion of the researcher, those who have or may have a disease that may interfere with the completion of the study
  • History of drug or alcohol dependence within 6 months
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

05

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
470 participants (actual)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. validation of the diagnostic algorithm of hypertension

    validation of the diagnostic algorithm of hypertension by using 24-hour ambulatory blood pressure and home blood pressure measurement

    Time frame: at baseline

Secondary outcomes

  1. the characteristics of patients showing discrepancy of diagnosis

    the characteristics of patients showing discrepancy of diagnosis between 24-hour ambulatory blood pressure and home blood pressure measurement

    Time frame: at baseline

  2. the change of diagnostic discrepancy

    the change of diagnostic discrepancy between 24-hour ambulatory blood pressure and home blood pressure measurement during follow up period more than 6 months

    Time frame: from baseline to more than 6 months

07

Study locations

1 site
  • Dongguk University Ilsan Hospital
    Goyang, Gyeonggi 10326, Korea, Republic of
08

References and documents

Individual participant data

Plan to share: No — In order to share the individual participant data, the informed consent from the research participants is required un the Korean law, and we did not get the consent to share at the beginning of this study.

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Ran from Nov 2015 to primary completion in Dec 2019, 49 months.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 24, 2019
First posted
Feb 27, 2019
StartActual
Nov 17, 2015
Primary completionActual
Dec 19, 2019
CompletionActual
Dec 31, 2020
Last update
Jul 12, 2021
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 12, 2021, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT03855605
Lead sponsor
DongGuk University
Responsible party
Moo-Yong Rhee (Professor, Principal Investigator, DongGuk University) — Principal investigator
First posted
Feb 27, 2019
Start date
Nov 17, 2015
Primary completion
Dec 19, 2019
Completion
Dec 31, 2020
Last update
Jul 12, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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Discussion

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