NCT07465549 CART BP Pro-Guided Blood Pressure Management for Uncontrolled Hypertension

Trial Parameters

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Brief Summary

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

Inclusion Criteria: 1. Age ≥ 19 years 2. Diagnosis of hypertension with ongoing antihypertensive treatment for at least one year 3. Uncontrolled hypertension defined as office systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg 4. Ability and willingness to provide written informed consent and comply with study procedures Exclusion Criteria: 1. History of intolerance or contraindication to olmesartan, amlodipine, or hydrochlorothiazide 2. Suspected secondary hypertension 3. Atrial fibrillation 4. Pregnancy or lactation 5. Any serious medical condition that may interfere with study participation or interpretation of study results

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