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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT03868384
Other study ID # DUMC-C1801
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


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
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