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NCT Number: NCT03868384

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

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.

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Key information

Conditions

Hypertension Ambulatory Blood Pressure Blood Pressure Cardiovascular Diseases Home Blood Pressure Measurement Vascular Diseases

Age range

20 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dongguk University Ilsan Hospital

Goyang-si, Gyeonggi-do, 10326, South Korea

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Difference of 24-hour blood pressure control rate

    Time frame: 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 outcomes

  1. Difference of daytime blood pressure control rate

    Time frame: 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

  2. Difference of office blood pressure control rate

    Time frame: 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

  3. Difference of systolic and diastolic blood pressure (office, 24-hour, daytime, nighttime)

    Time frame: 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

  4. Rate of home blood pressure measurement

    Time frame: at baseline and 3 years of follow up

    Rate of home blood pressure measurement in study population

  5. Reflection of home blood pressure

    Time frame: at baseline and 3 years of follow up

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

  6. cardiovascular disease prevalence and target organ damage

    Time frame: 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

  7. Changes of home blood pressure measurement rate

    Time frame: 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

  8. Cardiovascular disease events and target organ damage

    Time frame: 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

Sponsors and collaborators

Lead sponsor

DongGuk University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2026
First posted
Mar 11, 2019
Registry last updated
Jul 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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