Hypertension,Essential Clinical Trial
Official title:
Evaluation of Algorithm for Diagnosis of Hypertension by Home Blood Pressure Monitoring
Verified date | July 2021 |
Source | DongGuk University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
Status | Completed |
Enrollment | 470 |
Est. completion date | December 31, 2020 |
Est. primary completion date | December 19, 2019 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 20 Years and older |
Eligibility | 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 |
Country | Name | City | State |
---|---|---|---|
Korea, Republic of | Dongguk University Ilsan Hospital | Goyang | Gyeonggi |
Lead Sponsor | Collaborator |
---|---|
DongGuk University |
Korea, Republic of,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 |
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