Health TrialsbyHealthPanel

CART BP Pro-Guided Blood Pressure Management for Uncontrolled Hypertension

ConditionHypertension
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age19+
SponsorKorea University Anam Hospital

About this trial

This multicenter, prospective, open-label randomized controlled trial evaluates the efficacy and safety of CART BP Pro-guided blood pressure management in Korean patients with uncontrolled hypertension. CART BP Pro is a wearable cuffless blood pressure monitoring device based on photoplethysmography technology that enables continuous ambulatory blood pressure monitoring.

Eligible participants with uncontrolled hypertension despite ongoing antihypertensive therapy will be randomly assigned in a 1:1 ratio to either a CART BP Pro-guided management group or a usual care group based on conventional office blood pressure measurements. Antihypertensive treatment in both groups will follow guideline-based therapy using standard agents including angiotensin receptor blockers, calcium channel blockers, and thiazide diuretics.

The primary efficacy endpoint is the between-group difference in 24-hour mean systolic blood pressure at 24 weeks measured using ambulatory blood pressure monitoring. Safety will be assessed by the incidence of treatment-emergent adverse events during the study period.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Age ≥ 19 years

Uncontrolled hypertension defined as office systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg

Ability and willingness to provide written informed consent and comply with study procedures

Disqualifiers

History of intolerance or contraindication to olmesartan, amlodipine, or hydrochlorothiazide

Suspected secondary hypertension

Atrial fibrillation

Pregnancy or lactation

Trial design

Design model

Parallel

Treatments tested in this trial

  • CART BP Pro

    Device

    CART BP Pro is a wearable cuffless continuous blood pressure monitoring device based on photoplethysmography technology that enables 24-hour ambulatory blood pressure measurement.

  • Usual Care

    Other intervention

    Antihypertensive medication adjustments are based on office blood pressure measurements obtained during routine outpatient visits.

Treatment groups

400 Participants
are divided into 2 treatment groups
Group A: CART BP Pro-guided blood pressure managementExperimental treatment 1 intervention
Group B: Usual careActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

24-hour mean systolic blood pressure

Between-group difference in 24-hour mean systolic blood pressure measured using ambulatory blood pressure monitoring at 24 weeks.

Time frame
24 weeks

Secondary outcomes

1

Incidence of treatment-emergent adverse events (TEAEs)

Proportion of participants experiencing treatment-emergent adverse events during the study period.

Time frame
24 weeks
2

24-hour blood pressure load

Percentage of ambulatory blood pressure measurements exceeding predefined systolic or diastolic blood pressure thresholds over a 24-hour monitoring period.

Time frame
24 weeks
3

Target blood pressure achievement rate

Proportion of participants achieving predefined ambulatory blood pressure targets.

Time frame
24 weeks
4

Mean daytime and nighttime blood pressure

Mean systolic and diastolic blood pressure values during daytime and nighttime periods measured using ambulatory blood pressure monitoring.

Time frame
24 weeks

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Korea University Anam Hospital

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Collaborator

Source ClinicalTrials.gov
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