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

Sponsor
DongGuk University (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT03868384
Collaborator
(none)
701
1
101
6.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase

    Study Design

    Study Type:
    Observational [Patient Registry]
    Actual Enrollment :
    701 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of Home Blood Pressure Measurement for the Management of Hypertension in Treated Hypertensive Patients
    Actual Study Start Date :
    Aug 1, 2018
    Actual Primary Completion Date :
    May 13, 2020
    Anticipated Study Completion Date :
    Dec 31, 2026

    Outcome Measures

    Primary Outcome Measures

    1. 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 Outcome Measures

    1. 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

    2. 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

    3. 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

    4. Rate of home blood pressure measurement [at baseline and 3 years of follow up]

      Rate of home blood pressure measurement in study population

    5. 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

    6. 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

    7. 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

    8. 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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    20 Years and Older
    Sexes Eligible for Study:
    All
    Accepts 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

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Dongguk University Ilsan Hospital Goyang Gyeonggi Korea, Republic of 10326

    Sponsors and Collaborators

    • DongGuk University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Moo-Yong Rhee, Professor, DongGuk University
    ClinicalTrials.gov Identifier:
    NCT03868384
    Other Study ID Numbers:
    • DUMC-C1801
    First Posted:
    Mar 11, 2019
    Last Update Posted:
    Jul 12, 2021
    Last Verified:
    Jul 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of Jul 12, 2021