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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03868384
Recruitment Status : Active, not recruiting
First Posted : March 11, 2019
Last Update Posted : July 12, 2021
Sponsor:
Information provided by (Responsible Party):
Moo-Yong Rhee, DongGuk University

Study Description
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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
Hypertension Blood Pressure Home Blood Pressure Measurement Ambulatory Blood Pressure

Study Design
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Study Type : Observational [Patient Registry]
Actual Enrollment : 701 participants
Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration: 6 Years
Official Title: Evaluation of Home Blood Pressure Measurement for the Management of Hypertension in Treated Hypertensive Patients
Actual Study Start Date : August 1, 2018
Actual Primary Completion Date : May 13, 2020
Estimated Study Completion Date : December 31, 2026

Resource links provided by the National Library of Medicine


Groups and Cohorts
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Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   20 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   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.
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03868384


Locations
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Korea, Republic of
Dongguk University Ilsan Hospital
Goyang, Gyeonggi, Korea, Republic of, 10326
Sponsors and Collaborators
DongGuk University
More Information
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Additional Information:

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Responsible Party: Moo-Yong Rhee, Professor, DongGuk University
ClinicalTrials.gov Identifier: NCT03868384    
Other Study ID Numbers: DUMC-C1801
First Posted: March 11, 2019    Key Record Dates
Last Update Posted: July 12, 2021
Last Verified: July 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: 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.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hypertension
Vascular Diseases
Cardiovascular Diseases