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

Evaluation of Home Blood Pressure Measurement for the Management of Hypertension in Treated Hypertensive Patients

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Hypertension; Blood Pressure; Ambulatory Blood Pressure; Home Blood Pressure Measurement

• Study Type: Observational
• Enrollment (Actual): 701

Contacts and Locations

Study Locations

• Korea, Republic of
  • Gyeonggi
    • Goyang, Gyeonggi, Korea, Republic of, 10326
      • DongGuk University ilsan Hospital

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients with hypertension who were taking antihypertensive drugs for more than 1 year for treatment of hypertension are recruited through advertising in Goyang City where the hospital is located and Paju City near to the hospital.

Description

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 Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Difference of daytime blood pressure control rate	Difference of daytime blood pressure control rate between patients who measure and do not measure home blood pressure	at baseline and 3 years of follow up
Difference of office blood pressure control rate	Difference of office blood pressure control rate between patients who measure and do not measure home blood pressure	at baseline and 3 years of follow up
Difference of systolic and diastolic blood pressure (office, 24-hour, daytime, nighttime)	Difference of systolic and diastolic blood pressure (office, 24-hour, daytime, nighttime) between patients who measure and do not measure home blood pressure	at baseline and 3 years of follow up
Rate of home blood pressure measurement	Rate of home blood pressure measurement in study population	at baseline and 3 years of follow up
Reflection of home blood pressure	Rate of reflecting home blood pressure in the treatment of hypertension at office	at baseline and 3 years of follow up
cardiovascular disease prevalence and target organ damage	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	at baseline and 3 years of follow up
Changes of home blood pressure measurement rate	Changes of home blood pressure measurement rate in study population after 3 year of follow up from baseline	from baseline to 3 years of follow up
Cardiovascular disease events and target organ damage	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	during 3 years of follow up from baseline measurement

Collaborators and Investigators

• Sponsor: DongGuk University

Study record dates

Study Major Dates

• Study Start (Actual): August 1, 2018
• Primary Completion (Actual): May 13, 2020
• Study Completion (Anticipated): December 31, 2026

Study Registration Dates

• First Submitted: February 22, 2019
• First Submitted That Met QC Criteria: March 6, 2019
• First Posted (Actual): March 11, 2019

Study Record Updates

• Last Update Posted (Actual): July 12, 2021
• Last Update Submitted That Met QC Criteria: July 7, 2021
• Last Verified: July 1, 2021

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: DUMC-C1801

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No
• IPD Plan Description: In order to share the IPD, the informed consent from the research participants is required un the Korean law, and the investigators did not get the consent to share at the beginning of this study.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No