Hypertension,EssentialNCT03855605
Diagnosis of Hypertension by Home Blood Pressure Monitoring
An observational study of Hypertension,Essential and Home Blood Pressure, run by DongGuk University at 1 site in South Korea.
Trial summary
Home blood pressure measurement has been recommended to use in the diagnosis of hypertension. The investigators have developed diagnostic algorithm of hypertension by using 24-hour and home blood pressure measurement. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Hypertension,Essential, Home Blood Pressure, Ambulatory Blood Pressure
- How many people
- 470 participants
- Where
- 1 siteSouth Korea
- Study dates
- 17 Nov 2015to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
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: At the out-patient clinics, study investigators recruit study participants who have high blood pressure measured by them at the out-patient clinics and adequate for eligibility.
Who may be able to join
- Men and women
- Patients with high blood pressure measured by doctors at the outpatient office
Who cannot join
- Patients taking antihypertensive drugs or blood pressure affecting drugs within 1 month
- Secondary hypertension
- Hypertensive emergency and urgency
- Severe heart failure (NYHA III and IV)
- Angina with 6 months
- Myocardial infarction within 6 months
Show all 14Show fewer
- 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
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 Algorithm for Diagnosis of Hypertension by Home Blood Pressure Monitoring
Home blood pressure measurement has been recommended to use in the diagnosis of hypertension. The investigators have developed diagnostic algorithm of hypertension by using 24-hour and home blood pressure measurement. However, the diagnostic agreement between home blood pressure measurement and 24-hour ambulatory blood pressure measurement is about 70 - 85%. The discrepancy of diagnosis between home blood pressure measurement and 24-hour ambulatory blood pressure is one of the barriers to introduce home blood pressure measurement in the diagnosis of hypertension.
To solve the discrepancy, identifying the characteristic patients showing discrepancy of hypertension diagnosis between home blood pressure measurement and 24-hour ambulatory blood pressure measurement is needed.
The purpose of the present study are (1) to validate the diagnostic algorithm of hypertension by using 24-hour ambulatory blood pressure and home blood pressure measurement the investigators have developed, and (2) to identifying the characteristics of patients showing discrepancy of diagnosis between 24-hour ambulatory blood pressure and home blood pressure measurement, and (3) lastly to improve the diagnostic algorithm of hypertension by using home blood pressure measurement.
- Medical subject headings
- Essential Hypertension
What is being measured
The primary outcome is the main question the study is designed to answer.
validation of the diagnostic algorithm of hypertension
validation of the diagnostic algorithm of hypertension by using 24-hour ambulatory blood pressure and home blood pressure measurement
Measured: at baseline
Secondary outcomes (2)
the characteristics of patients showing discrepancy of diagnosis
the characteristics of patients showing discrepancy of diagnosis between 24-hour ambulatory blood pressure and home blood pressure measurement
Measured: at baseline
the change of diagnostic discrepancy
the change of diagnostic discrepancy between 24-hour ambulatory blood pressure and home blood pressure measurement during follow up period more than 6 months
Measured: from baseline to more than 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2019
- Study start17 Nov 2015
- Primary completion19 Dec 2019
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Hypertension,EssentialStudies 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
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 470 participants (actual)
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
- NCT03855605
- Sponsor's protocol ID
- DUMC-C1502
- Status last verified
- Jul 2021
- First submitted
- 24 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 individual participant data, the informed consent from the research participants is required un the Korean law, and we did not get the consent to share at the beginning of this study.
Publications
Lee YJ, Rhee MY, Kim JS, Do U, Kim JH, Kim BK, Kim HY. Association of the magnitude of the difference in blood pressure between office and ambulatory measurements with blood pressure variability in untreated individuals. Clin Hypertens. 2022 Dec 15;28(1):36. doi: 10.1186/s40885-022-00220-7.
PubMed 36517899
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 Algorithm for Diagnosis of Hypertension by Home Blood Pressure Monitoring
- ClinicalTrials.gov ID
- NCT03855605
- Acronym / sponsor ID
- DUMC-C1502
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 470 participants (actual)
- Lead sponsor
- DongGuk UniversityUniversity, hospital or other
- Study start
- 17 Nov 2015 (actual)
- Primary completion
- 19 Dec 2019 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 27 Feb 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 recommended to use in the diagnosis of hypertension. The investigators have developed diagnostic algorithm of hypertension by using 24-hour and home blood pressure measurement. However, the diagnostic agreement between home blood pressure measurement and 24-hour ambulatory blood pressure measurement is about 70 - 85%. The discrepancy of diagnosis between home blood pressure measurement and 24-hour ambulatory blood pressure is one of the barriers to introduce home blood pressure measurement in the diagnosis of hypertension.
To solve the discrepancy, identifying the characteristic patients showing discrepancy of hypertension diagnosis between home blood pressure measurement and 24-hour ambulatory blood pressure measurement is needed.
The purpose of the present study are (1) to validate the diagnostic algorithm of hypertension by using 24-hour ambulatory blood pressure and home blood pressure measurement the investigators have developed, and (2) to identifying the characteristics of patients showing discrepancy of diagnosis between 24-hour ambulatory blood pressure and home blood pressure measurement, and (3) lastly to improve the diagnostic algorithm of hypertension by using home blood pressure measurement.
Study design
- Observational model
- Case only
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- At the out-patient clinics, study investigators recruit study participants who have high blood pressure measured by them at the out-patient clinics and adequate for eligibility.
Key inclusion criteria (2 listed)
- Men and women
- Patients with high blood pressure measured by doctors at the outpatient office
Key exclusion criteria (14 listed)
- Patients taking antihypertensive drugs or blood pressure affecting drugs within 1 month
- Secondary hypertension
- Hypertensive emergency and urgency
- Severe heart failure (NYHA III and IV)
- Angina with 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
validation of the diagnostic algorithm of hypertension
Time frame: at baseline
validation of the diagnostic algorithm of hypertension by using 24-hour ambulatory blood pressure and home blood pressure measurement
2 secondary outcomes
the characteristics of patients showing discrepancy of diagnosis
Time frame: at baseline
the change of diagnostic discrepancy
Time frame: from baseline to more than 6 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Jul 2021.
- Derived from this study: PubMed 36517899Lee YJ, Rhee MY, Kim JS, Do U, Kim JH, Kim BK, Kim HY. Association of the magnitude of the difference in blood pressure between office and ambulatory measurements with blood pressure variability in untreated individuals. Clin Hypertens. 2022 Dec 15;28(1):36. doi: 10.1186/s40885-022-00220-7.
- Individual participant dataSharing planned: No. In order to share the individual participant data, the informed consent from the research participants is required un the Korean law, and we did not get the consent to share at the beginning of this study.
Related trials for Hypertension,Essential
Recruiting
The Effect of Self-Acupressure on Blood Pressure, Stress, and Well-Being Levels in Individuals With Hypertension
PRIMARY HYPERTENSION
Active, not recruiting
Smartphone-Guided Paced Breathing and Aerobic Exercise for Essential Hypertension
Essential (Primary) Hypertension
Recruiting
Isometric Resistance Exercise on Accelerated Atherosclerosis in Hypertension
Atherosclerosis Cardiovascular Disease
Not yet recruitingObservational study
A Study to Evaluate the Effectiveness and Safety of S-amlodipine-based Monotherapy and Combination Therapy
Hypertension (HTN), Hypertension
Recruiting
Community Health Worker Support to Lower Blood Pressure After a Pregnancy With High Blood Pressure
Pregnancy-Associated Hypertension, Gestational Hypertension
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,Essential and Home 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 2 inclusion and 14 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: finished, 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
validation of the diagnostic algorithm of hypertension (time frame: at baseline). 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 NCT03855605, which also lists 1 linked publication.
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.