Low Blood PressureNCT06491433
Clinical Trial of H2-BP Electronic Sphygmomanometer
A study testing H2-BP in people with Low Blood Pressure and Normal Blood Pressure, run by Gangnam Severance Hospital at 1 site in South Korea.
Trial summary
The study compares H2-BP, a wristband blood pressure monitor, with an auscultatory sphygmomanometer. Both devices are used on the same arm. After confirming wrist and upper arm circumference, H2-BP is operated by one measurer, while the auscultatory sphygmomanometer is simultaneously operated by two other measurers. Read more about this study
- Who is it for?
- Ages 19 years and olderHealthy volunteers can take part
- Conditions the study is for
- Low Blood Pressure, Normal Blood Pressure, Prehypertension
- What is being tested?
- H2-BP
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 141 participants
- Where
- 1 siteSouth Korea
- Study dates
- 27 Apr 2023to 15 Oct 2024
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 19 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Outpatients and inpatients aged 19 years or older showing hypotension, normal blood pressure, prehypertension, and hypertension
- Individuals who meet the criteria for wrist circumference, age, gender, and upper arm circumference as specified in the target number of participants.
- Those who have listened to a detailed explanation of the clinical trial, fully understand it, voluntarily decide to participate, and provide written consent to comply with precautions.
Who cannot join
- Patients who do not consent to participate in the study.
- Individuals who may not maintain stable blood pressure for approximately 30 minutes due to conditions resembling hypovolemia or similar conditions.
- Those who may not maintain stable blood pressure for approximately 30 minutes due to short-acting vasodilators or similar medications.
- Individuals with arrhythmia.
- Those who have eaten within 30 minutes before blood pressure measurement.
- Individuals who have consumed caffeine-containing beverages within 1 hour or smoked within 15 minutes before measurement.
- Participants who have exercised immediately before blood pressure measurement.
- Other patients deemed unsuitable for the study at the discretion of the researchers.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Prospective, Single Arm, Single Center, Non-randomized, Open Label Study to Evaluate the Accuracy of the Wrist Blood Pressure Monitor (H2-BP) Comparing With Aneroid Sphygmomanometer
The study compares H2-BP, a wristband blood pressure monitor, with an auscultatory sphygmomanometer. Both devices are used on the same arm. After confirming wrist and upper arm circumference, H2-BP is operated by one measurer, while the auscultatory sphygmomanometer is simultaneously operated by two other measurers. Each subject undergoes alternating measurements of H2-BP on one wrist and the auscultatory sphygmomanometer on the same arm until three valid measurement pairs are obtained per subject, with a maximum of eight repetitions allowed. The two auscultatory sphygmomanometer measurers operate independently and cannot see each other's measurements during the test. Measurements are repeated for 10 to 30 minutes until three valid blood pressure values are obtained and recorded. Validity assessment variables are derived from the recorded values to evaluate the accuracy of H2-BP.
- Being tested
- H2-BP
- Medical subject headings
- Hypotension, Prehypertension, Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
H2-BPDevice
Also called Sphygmomanometer, Blood Pressure Measurement
The patient will have the test device applied to one wrist to measure blood pressure and the control device applied to the upper arm of the same arm to measure blood pressure.
- H2-BP: The test device is placed on the wrist and presses a button to start pressurising. When the measurement is complete, the systolic and diastolic blood pressure is displayed on the screen.
- big ben® Sphygmomanometer: The cuff is placed on the upper arm and the pump is pressed manually to inflate. 2 measurers will measure systolic and diastolic blood pressure by connecting 2 stethoscopes separately to one cuff.
Due to the external nature of the study medical device, it is not possible to blind subjects and investigators, so that subjects and measurers are aware of the allocation. Therefore, blinding of subjects and measurers will not be used in this study.
| Study group | Role | What they receive |
|---|---|---|
| Test subjects using H2-BP and big ben® Sphygmomanometer | Experimental | Blood Pressure Measurement with the H2-BP Electronic Sphygmomanometer (H2-BP) and with aneroid Sphygmomanometer(big ben® Sphygmomanometer). Receives: Device: H2-BP |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean and Standard Deviation of Differences Between H2-BP Device and Aneroid Sphygmomanometer Measurements.
Average difference between blood pressure measurements obtained with the test medical device and the comparator.
Standard deviation of the difference between blood pressure measurements obtained with the test medical device and the comparator (based on the number of measurements).
Measured: serial assessment during 1 day
Secondary outcomes (1)
Standard Deviation of Differences Between H2-BP Device and Aneroid Sphygmomanometer Measurements.
Standard deviation of the difference in blood pressure measurements between the test device and the comparator (based on the number of participants)
Measured: secondary outcome will be out in 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2024
- Study start27 Apr 2023
- Primary completion15 Oct 2024
- Study completion15 Oct 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Low Blood PressureStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 141 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gangnam Severance Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Byoung Kwon Lee, Gangnam Severance Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06491433
- Sponsor's protocol ID
- 3-2022-0427
- Status last verified
- Feb 2025
- First submitted
- 30 Jun 2024
- Last updated
- 3 Mar 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Single Arm, Single Center, Non-randomized, Open Label Study to Evaluate the Accuracy of the Wrist Blood Pressure Monitor (H2-BP) Comparing With Aneroid Sphygmomanometer
- ClinicalTrials.gov ID
- NCT06491433
- Acronym / sponsor ID
- 3-2022-0427
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 141 participants (actual)
- Lead sponsor
- Gangnam Severance HospitalUniversity, hospital or other
- Study start
- 27 Apr 2023 (actual)
- Primary completion
- 15 Oct 2024 (actual)
- Study completion
- 15 Oct 2024 (actual)
- First posted
- 9 Jul 2024 (actual)
- Results
- Posted 3 Mar 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study compares H2-BP, a wristband blood pressure monitor, with an auscultatory sphygmomanometer. Both devices are used on the same arm. After confirming wrist and upper arm circumference, H2-BP is operated by one measurer, while the auscultatory sphygmomanometer is simultaneously operated by two other measurers. Each subject undergoes alternating measurements of H2-BP on one wrist and the auscultatory sphygmomanometer on the same arm until three valid measurement pairs are obtained per subject, with a maximum of eight repetitions allowed. The two auscultatory sphygmomanometer measurers operate independently and cannot see each other's measurements during the test. Measurements are repeated for 10 to 30 minutes until three valid blood pressure values are obtained and recorded. Validity assessment variables are derived from the recorded values to evaluate the accuracy of H2-BP.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Non-randomised
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Test subjects using H2-BP and big ben® Sphygmomanometer | Experimental | Device: H2-BPBlood Pressure Measurement with the H2-BP Electronic Sphygmomanometer (H2-BP) and with aneroid Sphygmomanometer(big ben® Sphygmomanometer). |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Outpatients and inpatients aged 19 years or older showing hypotension, normal blood pressure, prehypertension, and hypertension
- Individuals who meet the criteria for wrist circumference, age, gender, and upper arm circumference as specified in the target number of participants.
- Those who have listened to a detailed explanation of the clinical trial, fully understand it, voluntarily decide to participate, and provide written consent to comply with precautions.
Key exclusion criteria (8 listed)
- Patients who do not consent to participate in the study.
- Individuals who may not maintain stable blood pressure for approximately 30 minutes due to conditions resembling hypovolemia or similar conditions.
- Those who may not maintain stable blood pressure for approximately 30 minutes due to short-acting vasodilators or similar medications.
- Individuals with arrhythmia.
- Those who have eaten within 30 minutes before blood pressure measurement.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| H2-BPAlso: Sphygmomanometer, Blood Pressure MeasurementThe patient will have the test device applied to one wrist to measure blood pressure and the control device applied to the upper arm of the same arm to measure blood pressure. 1. H2-BP: The test device is placed on the wrist and presses a button to start pressurising. When the measurement is complete, the systolic and diastolic blood pressure is displayed on the screen. 2. big ben® Sphygmomanometer: The cuff is placed on the upper arm and the pump is pressed manually to inflate. 2 measurers will measure systolic and diastolic blood pressure by connecting 2 stethoscopes separately to one cuff. Due to the external nature of the study medical device, it is not possible to blind subjects and investigators, so that subjects and measurers are aware of the allocation. Therefore, blinding of subjects and measurers will not be used in this study. | Device | Test subjects using H2-BP and big ben® Sphygmomanometer |
Primary outcome
Mean and Standard Deviation of Differences Between H2-BP Device and Aneroid Sphygmomanometer Measurements.
Time frame: serial assessment during 1 day
Average difference between blood pressure measurements obtained with the test medical device and the comparator. Standard deviation of the difference between blood pressure measurements obtained with the test medical device and the comparator (based on the number of measurements).
1 secondary outcome
Standard Deviation of Differences Between H2-BP Device and Aneroid Sphygmomanometer Measurements.
Time frame: secondary outcome will be out in 1 day
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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?
A study testing H2-BP in people with Low Blood Pressure and Normal Blood Pressure, run by Gangnam Severance Hospital 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 3 inclusion and 8 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 3 Mar 2025. 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?
Yes. Results are posted in the registry (first posted 3 Mar 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Mean and Standard Deviation of Differences Between H2-BP Device and Aneroid Sphygmomanometer Measurements. (time frame: serial assessment during 1 day). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 3 Mar 2025.