Diagnosis of Hypertension by Home Blood Pressure Monitoring

NCT03855605 | Completed

• 1 other identifier: DUMC-C1502
• Study Type: observational
• Target: 470
• Locations: 1 country
• Sites: 1

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.

Conditions

Hypertension,Essential; Home Blood Pressure; Ambulatory Blood Pressure

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (2)

• the characteristics of patients showing discrepancy of diagnosis

  at baseline

• the change of diagnostic discrepancy

  from baseline to more than 6 months

Eligibility Criteria

• Age: 20 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

At the out-patient clinics, study investigators recruit study participants who have high blood pressure measured by them at the out-patient clinics and adequate for eligibility.

You may qualify if:

• Men and women
• Patients with high blood pressure measured by doctors at the outpatient office

You may not qualify if:

• 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

Sponsors & Collaborators

• DongGuk University: lead

Study Sites (1)

Dongguk University Ilsan Hospital

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

Location

Related Publications (1)

• Lee YJ, Rhee MY, Kim JS, Do U, Kim JH, Kim BK, Kim HY. Association of the magnitude of the difference in blood pressure between office and ambulatory measurements with blood pressure variability in untreated individuals. Clin Hypertens. 2022 Dec 15;28(1):36. doi: 10.1186/s40885-022-00220-7.

  PMID: 36517899 DERIVED

MeSH Terms

Conditions

Essential Hypertension

Condition Hierarchy (Ancestors)

Hypertension; Vascular Diseases; Cardiovascular Diseases

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor, Principal Investigator

Study Record Dates

• First Submitted: February 24, 2019
• First Posted: February 27, 2019
• Study Start: November 17, 2015
• Primary Completion: December 19, 2019
• Study Completion: December 31, 2020
• Last Updated: July 12, 2021

Record last verified: 2021-07

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)