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

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

Treatments tested in this trial

  • CART BP Pro
  • Usual Care

Treatment groups

400 Participants
are divided into 2 treatment groups

Sponsors and collaborators

Korea University Anam Hospital

Lead sponsor

Daewoong Pharmaceutical Co. LTD.

Collaborator