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Active, not recruitingNCT03868384Updated Jul 12, 2021

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

An observational study in Hypertension, Blood Pressure and Home Blood Pressure Measurement, sponsored by DongGuk University. Active, not recruiting at 1 site in Korea, Republic of. Open to participants aged 20 Years and older. Per ClinicalTrials.gov, last updated 2021-07-12.

Sponsored by DongGuk University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
701
Ages
20 Years and older
Sex
All
01

Study 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.

02

Conditions studied

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

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03

Who can participate

Ages eligible
20 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
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.

Inclusion criteria

  • Patients with hypertension and taking antihypertensive drugs more than 1 year

Exclusion criteria

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
04

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
701 participants (actual)
Target follow-up
6 Years
Patient registry
Yes
05

What researchers measure

Primary outcomes

  1. 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

    Time frame: at baseline and 3 years of follow up

Secondary outcomes

  1. 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

    Time frame: at baseline and 3 years of follow up

  2. 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

    Time frame: at baseline and 3 years of follow up

  3. 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

    Time frame: at baseline and 3 years of follow up

  4. Rate of home blood pressure measurement

    Rate of home blood pressure measurement in study population

    Time frame: at baseline and 3 years of follow up

  5. Reflection of home blood pressure

    Rate of reflecting home blood pressure in the treatment of hypertension at office

    Time frame: at baseline and 3 years of follow up

  6. 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

    Time frame: at baseline and 3 years of follow up

  7. 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

    Time frame: from baseline to 3 years of follow up

  8. 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

    Time frame: during 3 years of follow up from baseline measurement

06

Study locations

1 site
  • Dongguk University Ilsan Hospital
    Goyang, Gyeonggi 10326, Korea, Republic of
07

References and documents

Individual participant data

Plan to share: No — 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.

No publications or documents are linked to this record.

08

Registry details

Key details

Study ID
NCT03868384
Lead sponsor
DongGuk University
Responsible party
Moo-Yong Rhee (Professor, DongGuk University) — Principal investigator
First posted
Mar 11, 2019
Start date
Aug 1, 2018
Primary completion
May 13, 2020
Completion
Dec 31, 2026 (estimated)
Last update
Jul 12, 2021

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
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Not currently enrolling

This study is active, not recruiting, as verified in Jul 2021. You cannot join it, but the record below documents what was studied.

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