Clinical trial NCT03868384: The Effect of Home Blood Pressure Measurement on the Management of Hypertension
Official title: Evaluation of Home Blood Pressure Measurement for the Management of Hypertension in Treated Hypertensive Patients
Study type: OBSERVATIONAL
Overall status: ACTIVE_NOT_RECRUITING
Conditions: Hypertension
Blood Pressure
Home Blood Pressure Measurement
Ambulatory Blood Pressure
Lead sponsor: DongGuk University
Sponsor class: OTHER
First posted: 2019-03-11
Enrollment: 701
Sex: ALL
Minimum age (years): 20
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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.


Eligibility criteria: 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

Primary outcomes:
measure: Difference of 24-hour blood pressure control rate
timeFrame: at baseline and 3 years of follow up
Secondary outcomes:
measure: Difference of daytime blood pressure control rate
timeFrame: at baseline and 3 years of follow up
measure: Difference of office blood pressure control rate
timeFrame: at baseline and 3 years of follow up
measure: Difference of systolic and diastolic blood pressure (office, 24-hour, daytime, nighttime)
timeFrame: at baseline and 3 years of follow up
measure: Rate of home blood pressure measurement
timeFrame: at baseline and 3 years of follow up
measure: Reflection of home blood pressure
timeFrame: at baseline and 3 years of follow up
measure: cardiovascular disease prevalence and target organ damage
timeFrame: at baseline and 3 years of follow up
measure: Changes of home blood pressure measurement rate
timeFrame: from baseline to 3 years of follow up
measure: Cardiovascular disease events and target organ damage
timeFrame: during 3 years of follow up from baseline measurement
Other outcomes:
Locations:
city: Goyang
country: Korea, Republic of
facility: Dongguk University Ilsan Hospital
state: Gyeonggi
Study officials:
References: