CClinicalTrials.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

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.

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 (NYHA 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
04

Study design

Observational model
Case-only
Time perspective
Cross-sectional
Enrollment
470 participants (actual)
Patient registry
No
05

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

06

Study locations

1 site
  • Dongguk University Ilsan Hospital
    Goyang, Gyeonggi 10326, Korea, Republic of
07

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.

08

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.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion