Diagnosis of Hypertension by Home Blood Pressure Monitoring

Evaluation of Algorithm for Diagnosis of Hypertension by Home Blood Pressure Monitoring

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.

Study Overview

• Status: Completed
• Conditions: Hypertension,Essential; Ambulatory Blood Pressure; Home Blood Pressure

• Study Type: Observational
• Enrollment (Actual): 470

Contacts and Locations

Study Locations

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

Participation Criteria

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

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.

Description

Inclusion Criteria:

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

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	at baseline

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	at baseline
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	from baseline to more than 6 months

Collaborators and Investigators

• Sponsor: DongGuk University

Study record dates

Study Major Dates

• Study Start (Actual): November 17, 2015
• Primary Completion (Actual): December 19, 2019
• Study Completion (Actual): December 31, 2020

Study Registration Dates

• First Submitted: February 24, 2019
• First Submitted That Met QC Criteria: February 24, 2019
• First Posted (Actual): February 27, 2019

Study Record Updates

• Last Update Posted (Actual): July 12, 2021
• Last Update Submitted That Met QC Criteria: July 7, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension; Essential Hypertension
• Other Study ID Numbers: DUMC-C1502

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No