Diagnosis of Hypertension by Home Blood Pressure Monitoring

Hypertension,Essential Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03855605
• Other study ID #: DUMC-C1502
• Status: Completed
• Start date: November 17, 2015
• Est. completion date: December 31, 2020

Study information

• Verified date: July 2021
• Source: DongGuk University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• 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

Related Conditions & MeSH terms

• Ambulatory Blood Pressure
• Essential Hypertension
• Home Blood Pressure
• Hypertension
• Hypertension,Essential

Locations

Country	Name	City	State
Korea, Republic of	Dongguk University Ilsan Hospital	Goyang	Gyeonggi

Sponsors (1)

Lead Sponsor	Collaborator
DongGuk University

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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