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Diagnosis of Hypertension by Home Blood Pressure Monitoring

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT03855605
Enrollment
470
Registered
2019-02-27
Start date
2015-11-17
Completion date
2020-12-31
Last updated
2021-07-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Ambulatory Blood Pressure, Home Blood Pressure, Hypertension,Essential

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.

Interventions

None listed

Sponsors

DongGuk University
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
20 Years to No maximum
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

Design outcomes

Primary

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

Secondary

MeasureTime frameDescription
the characteristics of patients showing discrepancy of diagnosisat baselinethe characteristics of patients showing discrepancy of diagnosis between 24-hour ambulatory blood pressure and home blood pressure measurement
the change of diagnostic discrepancyfrom baseline to more than 6 monthsthe change of diagnostic discrepancy between 24-hour ambulatory blood pressure and home blood pressure measurement during follow up period more than 6 months

Countries

South Korea

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 12, 2026