The Effect of Home Blood Pressure Measurement on the Management of Hypertension

Active, not recruiting

• Conditions: Hypertension; Home Blood Pressure Measurement; Ambulatory Blood Pressure; Blood Pressure

• Registration Number: NCT03868384
• Lead Sponsor: DongGuk University

Brief Summary

Home blood pressure measurement has been reported to be associated with better clinic blood pressure and daytime blood pressure control. However, no study has evaluated the association between home blood pressure measurement and control of 24-hour ambulatory blood pressure in real world practice.

The purpose of the present study is to investigate the effect of home blood pressure measurement on the control of ambulatory blood pressure in the real world.

The detailed purposes of the present study are (1) to investigate the effects of home blood pressure measurement on the appropriate control of 24-hour ambulatory blood pressure in hypertensive patients treated with antihypertensive drug, (2) to evaluate the effect of home blood pressure measurement on the occurrence of cardiovascular events and target organ damage, (3) to investigate the status and appropriateness of home blood pressure measurement in the real world, and (4) to investigate factors of home blood pressure measurement methods affecting the treatment of hypertension.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-08-01
• Study First Submitted: 2019-02-22
• Study First Submitted QC: 2019-03-06
• Study First Posted: 2019-03-11
• Primary Completion: 2020-05-13
• Status Verified: 2021-07
• Last Update Submitted: 2021-07-07
• Last Update Posted: 2021-07-12
• Study Completion: 2026-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 701

Inclusion Criteria

• Patients with hypertension and taking antihypertensive drugs more than 1 year

Exclusion Criteria

• 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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Difference of 24-hour blood pressure control rate	at baseline and 3 years of follow up	difference of 24-hour blood pressure control rate between patients who measure and do not measure home blood pressure

Secondary Outcome Measures

Name	Time	Method
Rate of home blood pressure measurement	at baseline and 3 years of follow up	Rate of home blood pressure measurement in study population
Reflection of home blood pressure	at baseline and 3 years of follow up	Rate of reflecting home blood pressure in the treatment of hypertension at office
Difference of daytime blood pressure control rate	at baseline and 3 years of follow up	Difference of daytime blood pressure control rate between patients who measure and do not measure home blood pressure
Difference of office blood pressure control rate	at baseline and 3 years of follow up	Difference of office blood pressure control rate between patients who measure and do not measure home blood pressure
Difference of systolic and diastolic blood pressure (office, 24-hour, daytime, nighttime)	at baseline and 3 years of follow up	Difference of systolic and diastolic blood pressure (office, 24-hour, daytime, nighttime) between patients who measure and do not measure home blood pressure
cardiovascular disease prevalence and target organ damage	at baseline and 3 years of follow up	Difference of cardiovascular disease prevalence and target organ damage between patient who do or do not measure home blood pressure; * Composites of cardiovascular disease: number of participants with non-fatal myocardial infarction, angina pectoris, revascularization of arteries, stroke, transient ischemic attack, atrial fibrillation, heart failure hospitalization, progression to end-stage renal failure or elevation of creatinine more than 2-fold, other undefined cardiovascular events at the discretion of the investigator; * Target organ damage: left ventricular hypertrophy by electrocardiography, brachial-ankle pulse wave velocity, microalbuminuria
Changes of home blood pressure measurement rate	from baseline to 3 years of follow up	Changes of home blood pressure measurement rate in study population after 3 year of follow up from baseline
Cardiovascular disease events and target organ damage	during 3 years of follow up from baseline measurement	Difference of occurrence of cardiovascular disease events and target organ damage between patient who measure and do not measure home blood pressure; * Composites of cardiovascular disease events: number of participants with first occurrence of non-fatal myocardial infarction, angina pectoris, revascularization of arteries, stroke, transient ischemic attack, atrial fibrillation, heart failure hospitalization, progression to end-stage renal failure or elevation of creatinine more than 2-fold, other undefined cardiovascular events at the discretion of the investigator; * Target organ damage: left ventricular hypertrophy by electrocardiography, brachial-ankle pulse wave velocity, microalbuminuria from enrollment

Trial Locations

Locations (1)

Dongguk University Ilsan Hospital; 🇰🇷 Goyang, Gyeonggi, Korea, Republic of