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.

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Key information

Conditions

Hypertension,Essential Ambulatory Blood Pressure Cardiovascular Diseases Essential Hypertension Home Blood Pressure Hypertension Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dongguk University Ilsan Hospital

Goyang-si, Gyeonggi-do, 10326, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

validation of the diagnostic algorithm of hypertension

Time frame: at baseline

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

Secondary outcomes

the characteristics of patients showing discrepancy of diagnosis

Time frame: at baseline

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

Time frame: 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

Sponsors and collaborators

Lead sponsor

DongGuk University

Other

Registry information

Official study title

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

Important dates

Study start: 2015
Primary completion: 2019
Study completion: 2020
First posted: Feb 27, 2019
Registry last updated: Jul 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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