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

Hypertension Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT03868384
• Other study ID #: DUMC-C1801
• Status: Active, not recruiting
• Start date: August 1, 2018
• Est. completion date: December 31, 2026

Study information

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

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 701
• Est. completion date: December 31, 2026
• Est. primary completion date: May 13, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 20 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Ambulatory Blood Pressure
• Blood Pressure
• Home Blood Pressure Measurement
• Hypertension

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	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	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
Secondary	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
Secondary	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
Secondary	Rate of home blood pressure measurement	Rate of home blood pressure measurement in study population	at baseline and 3 years of follow up
Secondary	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
Secondary	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
Secondary	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
Secondary	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