HypertensionNCT07454148
CART-BP Prospective Study for Hypertension Control
A study testing CART BP pro in people with Hypertension, run by Korea University Anam Hospital at 1 site in South Korea.
Trial summary
This prospective, open-label, non-randomized study evaluates the effectiveness and safety of a CART BP pro(a brand name of cuffless ambulatory blood pressure monitoring device)-guided blood pressure management strategy in Korean patients with uncontrolled hypertension. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Hypertension
- What is being tested?
- CART BP pro
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 288 participants
- Where
- 1 siteSouth Korea
- Study dates
- 25 Mar 2025to 4 May 2026
- Phase
- Interventional
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age >= 19 years
- Office systolic blood pressure(BP) >= 140 mmHg or diastolic BP >= 90 mmHg
- Able and willing to provide written informed consent and comply with follow-up visits
Who cannot join
- History of intolerance to olmesartan, amlodipine, or hydrochlorothiazide
- Suspected secondary hypertension
- Atrial fibrillation
- Pregnancy or lactation
- Other serious medical condition that may interfere with study participation
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Korea University Anam Hospital
Seoul, Choose One..., 02841
About this study
Official title: Efficacy and Safety of Cuffless Ambulatory Blood Pressure Monitoring Device-Guided Blood Pressure Management in Korean Patients With Uncontrolled Hypertension: A Prospective Non-Randomized Study
This prospective, open-label, non-randomized study evaluates the effectiveness and safety of a CART BP pro(a brand name of cuffless ambulatory blood pressure monitoring device)-guided blood pressure management strategy in Korean patients with uncontrolled hypertension. Participants are allocated to either a CART BP pro-guided management group or a usual care group based on clinical decision and participant preference. The primary efficacy endpoint is 24-hour mean ambulatory systolic blood pressure at 24 weeks; safety outcomes including treatment-emergent adverse events (TEAEs) are also assessed.
Read the detailed description
Hypertension remains suboptimally controlled despite combination pharmacotherapy, and office blood pressure measurements may not adequately reflect true ambulatory blood pressure burden and nocturnal patterns. CART BP pro is a wearable, cuffless photoplethysmography-based continuous blood pressure monitoring device. This study investigates whether a CART BP pro-guided antihypertensive titration strategy improves 24-hour ambulatory blood pressure control compared with usual care in real-world outpatient settings. Participants receive standard antihypertensive medications (e.g., angiotensin receptor blocker [ARB], calcium channel blocker [CCB], thiazide diuretic) per guideline-based care. In the CART BP pro-guided group, medication adjustments are informed by CART BP pro-derived 24-hour blood pressure data. Follow-up is 24 weeks with optional extended follow-up to 48 weeks.
- Conditions
- Hypertension
- Being tested
- CART BP pro, Usual care (office BP-based management)
- Keywords
- Hypertension, Ambulatory blood pressure monitoring, Cuffless blood pressure monitoring, Wearable blood pressure device, CART BP Pro
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CART BP proDevice
Wearable cuffless continuous blood pressure monitoring device.
Usual care (office BP-based management)Other
Standard hypertension management based on office blood pressure.
| Study group | Role | What they receive |
|---|---|---|
| CART BP pro-guided management | Experimental | Participants undergo 24-hour continuous blood pressure monitoring with CART BP pro. Antihypertensive medications are adjusted based on ambulatory blood pressure data. Receives: Device: CART BP pro |
| Usual care | Active comparator | Participants receive antihypertensive medication adjustments based on office blood pressure measurements according to standard clinical practice. Receives: Other: Usual care (office BP-based management) |
What is being measured
The primary outcome is the main question the study is designed to answer.
24-hour mean systolic blood pressure
Between-group difference in 24-hour mean ambulatory systolic blood pressure measured using the CART BP Pro device at 24 weeks.
Measured: 24 weeks
Secondary outcomes (4)
Incidence of treatment-emergent adverse events (TEAE)
Proportion of participants experiencing TEAEs during the 24-week study period.
Measured: 24 weeks
24-hour blood pressure load
Percentage of valid ambulatory BP readings exceeding prespecified thresholds over 24 hours.
Measured: 24 weeks
Office blood pressure change
Change in office systolic and diastolic blood pressure from baseline to 24 weeks.
Measured: 24 weeks
Target blood pressure achievement rate
Proportion of participants achieving prespecified ambulatory BP targets.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2026
- Study start25 Mar 2025
- Primary completion4 May 2026 (estimated)
- Study completion4 May 2026 (estimated)
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 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Participants are allocated to either a CART BP Pro-guided management group or a usual care group. Treatment decisions in the CART BP Pro-guided group are informed by continuous ambulatory blood pressure data obtained from the wearable device, whereas treatment decisions in the usual care group are based on conventional office blood pressure measurements.
- Masking
- None (open label)
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Korea University Anam Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hyung Joon Joo, Korea University Anam Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07454148
- Sponsor's protocol ID
- CARTBP-HTN-P1-2025
- Status last verified
- Mar 2026
- First submitted
- 2 Mar 2026
- Last updated
- 10 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: De-identified individual participant data collected in this study are not currently planned to be shared with external researchers. Data sharing may be considered in the future subject to institutional review board approval and institutional data governance policies.
Publications
Cha JJ, Kim MN, Kim SR, Park JH, Joo HJ, Yu CW. Cuffless 24-hour ambulatory blood pressure monitoring-guided antihypertensive titration in real-world clinical practice: a prospective non-randomized study. Clin Hypertens. 2026 Oct 1;32:e42. doi: 10.5646/ch.2026.32.e42. eCollection 2026.
PubMed 42846709
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Cuffless Ambulatory Blood Pressure Monitoring Device-Guided Blood Pressure Management in Korean Patients With Uncontrolled Hypertension: A Prospective Non-Randomized Study
- ClinicalTrials.gov ID
- NCT07454148
- Acronym / sponsor ID
- CARTBP-HTN-P1-2025
- Conditions
- Hypertension
- Keywords
- Hypertension, Ambulatory blood pressure monitoring, Cuffless blood pressure monitoring, Wearable blood pressure device, CART BP Pro
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 288 participants (actual)
- Lead sponsor
- Korea University Anam HospitalUniversity, hospital or other
- Study start
- 25 Mar 2025 (actual)
- Primary completion
- 4 May 2026 (estimated)
- Study completion
- 4 May 2026 (estimated)
- First posted
- 6 Mar 2026 (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.
This prospective, open-label, non-randomized study evaluates the effectiveness and safety of a CART BP pro(a brand name of cuffless ambulatory blood pressure monitoring device)-guided blood pressure management strategy in Korean patients with uncontrolled hypertension. Participants are allocated to either a CART BP pro-guided management group or a usual care group based on clinical decision and participant preference. The primary efficacy endpoint is 24-hour mean ambulatory systolic blood pressure at 24 weeks; safety outcomes including treatment-emergent adverse events (TEAEs) are also assessed.
Detailed description
Hypertension remains suboptimally controlled despite combination pharmacotherapy, and office blood pressure measurements may not adequately reflect true ambulatory blood pressure burden and nocturnal patterns. CART BP pro is a wearable, cuffless photoplethysmography-based continuous blood pressure monitoring device. This study investigates whether a CART BP pro-guided antihypertensive titration strategy improves 24-hour ambulatory blood pressure control compared with usual care in real-world outpatient settings. Participants receive standard antihypertensive medications (e.g., angiotensin receptor blocker [ARB], calcium channel blocker [CCB], thiazide diuretic) per guideline-based care. In the CART BP pro-guided group, medication adjustments are informed by CART BP pro-derived 24-hour blood pressure data. Follow-up is 24 weeks with optional extended follow-up to 48 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Participants are allocated to either a CART BP Pro-guided management group or a usual care group. Treatment decisions in the CART BP Pro-guided group are informed by continuous ambulatory blood pressure data obtained from the wearable device, whereas treatment decisions in the usual care group are based on conventional office blood pressure measurements.
| Arm | Type | Receives |
|---|---|---|
| CART BP pro-guided management | Experimental | Device: CART BP proParticipants undergo 24-hour continuous blood pressure monitoring with CART BP pro. Antihypertensive medications are adjusted based on ambulatory blood pressure data. |
| Usual care | Active comparator | Other: Usual care (office BP-based management)Participants receive antihypertensive medication adjustments based on office blood pressure measurements according to standard clinical practice. |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Age >= 19 years
- Office systolic blood pressure(BP) >= 140 mmHg or diastolic BP >= 90 mmHg
- Able and willing to provide written informed consent and comply with follow-up visits
Key exclusion criteria (5 listed)
- History of intolerance to olmesartan, amlodipine, or hydrochlorothiazide
- Suspected secondary hypertension
- Atrial fibrillation
- Pregnancy or lactation
- Other serious medical condition that may interfere with study participation
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 |
|---|---|---|
| CART BP proWearable cuffless continuous blood pressure monitoring device. | Device | CART BP pro-guided management |
| Usual care (office BP-based management)Standard hypertension management based on office blood pressure. | Other | Usual care |
Primary outcome
24-hour mean systolic blood pressure
Time frame: 24 weeks
Between-group difference in 24-hour mean ambulatory systolic blood pressure measured using the CART BP Pro device at 24 weeks.
4 secondary outcomes
Incidence of treatment-emergent adverse events (TEAE)
Time frame: 24 weeks
24-hour blood pressure load
Time frame: 24 weeks
Office blood pressure change
Time frame: 24 weeks
Target blood pressure achievement rate
Time frame: 24 weeks
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 10 Mar 2026.
- Derived from this study: PubMed 42846709Cha JJ, Kim MN, Kim SR, Park JH, Joo HJ, Yu CW. Cuffless 24-hour ambulatory blood pressure monitoring-guided antihypertensive titration in real-world clinical practice: a prospective non-randomized study. Clin Hypertens. 2026 Oct 1;32:e42. doi: 10.5646/ch.2026.32.e42. eCollection 2026.
- Individual participant dataSharing planned: No. De-identified individual participant data collected in this study are not currently planned to be shared with external researchers. Data sharing may be considered in the future subject to institutional review board approval and institutional data governance policies.
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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 CART BP pro in people with Hypertension, run by Korea University Anam 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 5 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 10 Mar 2026. 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?
24-hour mean systolic blood pressure (time frame: 24 weeks). 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 NCT07454148, 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 10 Mar 2026.