Clincosm LogoSign in Get a demo

Diagnosis of Hypertension by Home Blood Pressure Monitoring

Sponsor
DongGuk University (Other)
Overall Status
Completed
CT.gov ID
NCT03855605
Collaborator
(none)
470
Enrollment
1
Location
61.5
Actual Duration (Months)
7.6
Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    470 participants
    Observational Model:
    Case-Only
    Time Perspective:
    Cross-Sectional
    Official Title:
    Evaluation of Algorithm for Diagnosis of Hypertension by Home Blood Pressure Monitoring
    Actual Study Start Date :
    Nov 17, 2015
    Actual Primary Completion Date :
    Dec 19, 2019
    Actual Study Completion Date :
    Dec 31, 2020

    Outcome Measures

    Primary Outcome Measures

    1. validation of the diagnostic algorithm of hypertension [at baseline]

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

    Secondary Outcome Measures

    1. the characteristics of patients showing discrepancy of diagnosis [at baseline]

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

    2. the change of diagnostic discrepancy [from baseline to more than 6 months]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dongguk University Ilsan Hospital Goyang Gyeonggi Korea, Republic of 10326

    Sponsors and Collaborators

    • DongGuk University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Moo-Yong Rhee, Professor, Principal Investigator, DongGuk University
    ClinicalTrials.gov Identifier:
    NCT03855605
    Other Study ID Numbers:
    • DUMC-C1502
    First Posted:
    Feb 27, 2019
    Last Update Posted:
    Jul 12, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Hypertension
    Essential Hypertension

    Study Results

    No Results Posted as of Jul 12, 2021