HypertensionNCT03868384
The Effect of Home Blood Pressure Measurement on the Management of Hypertension
An observational study of Hypertension and Blood Pressure, run by DongGuk University at 1 site in South Korea.
Trial 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. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hypertension, Blood Pressure, Home Blood Pressure Measurement
- How many people
- 701 participants
- Where
- 1 siteSouth Korea
- Study dates
- 1 Aug 2018to 31 Dec 2026
- How long will I take part?
- 6 Years
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- Patients with hypertension and taking antihypertensive drugs more than 1 year
Who cannot join
- 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
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Dongguk University Ilsan Hospital
Goyang-si, Gyeonggi-do, 10326
About this study
Official title: Evaluation of Home Blood Pressure Measurement for the Management of Hypertension in Treated Hypertensive Patients
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.
- Medical subject headings
- Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: at baseline and 3 years of follow up
Secondary outcomes (8)
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
Measured: at baseline and 3 years of follow up
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
Measured: at baseline and 3 years of follow up
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
Measured: at baseline and 3 years of follow up
Rate of home blood pressure measurement
Rate of home blood pressure measurement in study population
Measured: at baseline and 3 years of follow up
Reflection of home blood pressure
Rate of reflecting home blood pressure in the treatment of hypertension at office
Measured: at baseline and 3 years of follow up
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
Measured: at baseline and 3 years of follow up
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
Measured: from baseline to 3 years of follow up
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
Measured: during 3 years of follow up from baseline measurement
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2019
- Study start1 Aug 2018
- Primary completion13 May 2020
- Study completion31 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 701 participants (actual)
- Target duration
- 6 Years
Sponsor and investigators
- Lead sponsor
- DongGuk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Moo-Yong Rhee, DongGuk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03868384
- Sponsor's protocol ID
- DUMC-C1801
- Status last verified
- Jul 2021
- First submitted
- 22 Feb 2019
- Last updated
- 12 Jul 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Lee KJ, Rhee MY. Status of home blood pressure measurement in treated hypertensive patients. Results of a survey from two cities in Korea. J Clin Hypertens (Greenwich). 2024 Jul;26(7):825-831. doi: 10.1111/jch.14808. Epub 2024 Jun 17.
PubMed 38884638Rhee MY, Munakata M, Nah DY, Kim JS, Kim HY. Home blood pressure measurement for hypertension management in the real world: Do not just measure, but share with your physician. Front Cardiovasc Med. 2023 Jan 18;10:1103216. doi: 10.3389/fcvm.2023.1103216. eCollection 2023.
PubMed 36742078
Study at a glance
From the registry record, last updated by the sponsor on 12 Jul 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Home Blood Pressure Measurement for the Management of Hypertension in Treated Hypertensive Patients
- ClinicalTrials.gov ID
- NCT03868384
- Acronym / sponsor ID
- DUMC-C1801
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 701 participants (actual)
- Lead sponsor
- DongGuk UniversityUniversity, hospital or other
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 13 May 2020 (actual)
- Study completion
- 31 Dec 2026 (estimated)
- First posted
- 11 Mar 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 6 Years
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (1 listed)
- Patients with hypertension and taking antihypertensive drugs more than 1 year
Key exclusion criteria (13 listed)
- Secondary hypertension
- Hypertensive emergency and urgency
- Severe heart failure (NYHA III and IV)
- Angina with 6 months
- Myocardial infarction within 6 months
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
8 secondary outcomes
Difference of daytime blood pressure control rate
Time frame: at baseline and 3 years of follow up
Difference of office blood pressure control rate
Time frame: at baseline and 3 years of follow up
Difference of systolic and diastolic blood pressure (office, 24-hour, daytime, nighttime)
Time frame: at baseline and 3 years of follow up
Rate of home blood pressure measurement
Time frame: at baseline and 3 years of follow up
Reflection of home blood pressure
Time frame: at baseline and 3 years of follow up
cardiovascular disease prevalence and target organ damage
Time frame: at baseline and 3 years of follow up
Changes of home blood pressure measurement rate
Time frame: from baseline to 3 years of follow up
Cardiovascular disease events and target organ damage
Time frame: during 3 years of follow up from baseline measurement
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2021.
- Derived from this study: PubMed 38884638Lee KJ, Rhee MY. Status of home blood pressure measurement in treated hypertensive patients. Results of a survey from two cities in Korea. J Clin Hypertens (Greenwich). 2024 Jul;26(7):825-831. doi: 10.1111/jch.14808. Epub 2024 Jun 17.
- Derived from this study: PubMed 36742078Rhee MY, Munakata M, Nah DY, Kim JS, Kim HY. Home blood pressure measurement for hypertension management in the real world: Do not just measure, but share with your physician. Front Cardiovasc Med. 2023 Jan 18;10:1103216. doi: 10.3389/fcvm.2023.1103216. eCollection 2023.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Blood Pressure, run by DongGuk University at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 12 Jul 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Difference of 24-hour blood pressure control rate (time frame: at baseline and 3 years of follow up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03868384, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Jul 2021.