Ambulatory Blood Pressure, Blood Pressure, Home Blood Pressure Measurement, Hypertension
Conditions
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.
Interventions
None listed
Sponsors
DongGuk University
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| Rate of home blood pressure measurement | at baseline and 3 years of follow up | Rate of home blood pressure measurement in study population |
| 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 |
| 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 |
| 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 |
Countries
South Korea
Outcome results
None listed