[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100628738":3},{"organization":4,"outcomesModule":7,"designInfo":30,"detailedDescription":37,"studyPopulation":29,"armGroups":38,"interventions":51,"overallOfficials":29,"centralContacts":61,"locations":67,"responsibleParty":125,"collaborators":127,"id":131,"slug":29,"hasResults":132,"nctId":133,"briefTitle":134,"officialTitle":135,"acronym":136,"eligibilityCriteria":137,"healthyVolunteers":132,"sex":138,"minAge":139,"maxAge":29,"enrollmentInfo":140,"targetDuration":29,"studyType":143,"phases":144,"briefSummary":146,"conditions":147,"keywords":149,"overallStatus":70,"whyStopped":29,"lastUpdateSubmitDate":153,"lastUpdatePostDateStruct":154,"startDateStruct":157,"completionDateStruct":159,"leadSponsor":161,"locationsCount":162},{"fullName":5,"class":6},"Korea University Anam Hospital","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":29},[9],{"measure":10,"description":11,"timeFrame":12},"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.","24 weeks",[14,17,20,23,26],{"measure":15,"description":16,"timeFrame":12},"Incidence of treatment-emergent adverse events (TEAEs)","Proportion of participants experiencing treatment-emergent adverse events during the study period.",{"measure":18,"description":19,"timeFrame":12},"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.",{"measure":21,"description":22,"timeFrame":12},"Target blood pressure achievement rate","Proportion of participants achieving predefined ambulatory blood pressure targets.",{"measure":24,"description":25,"timeFrame":12},"Mean daytime and nighttime blood pressure","Mean systolic and diastolic blood pressure values during daytime and nighttime periods measured using ambulatory blood pressure monitoring.",{"measure":27,"description":28,"timeFrame":12},"Office blood pressure change","Change in office systolic and diastolic blood pressure from baseline to 24 weeks.",null,{"allocation":31,"interventionModel":32,"interventionModelDescription":33,"primaryPurpose":34,"observationalModel":29,"timePerspective":29,"maskingInfo":35},"RANDOMIZED","PARALLEL","Participants will be randomly assigned in a 1:1 ratio to either the CART BP Pro-guided management group or the usual care group using an electronic case report form-based randomization system. Antihypertensive treatment will be adjusted according to ambulatory blood pressure data obtained from the CART BP Pro device in the intervention group and according to conventional office blood pressure measurements in the usual care group.","TREATMENT",{"masking":36,"maskingDescription":29,"whoMasked":29},"NONE","Hypertension remains one of the most prevalent chronic conditions worldwide and is a major contributor to cardiovascular morbidity and mortality. Although multiple antihypertensive medications are widely used, a substantial proportion of patients remain inadequately controlled. Office blood pressure measurements alone may not adequately reflect the true blood pressure burden or nocturnal blood pressure patterns. Ambulatory blood pressure monitoring provides a more comprehensive assessment of blood pressure variability and control but is limited by patient discomfort and practical constraints. Recently developed wearable cuffless blood pressure monitoring devices have the potential to provide continuous and convenient blood pressure assessment in real-world settings.\n\nCART BP Pro is a wearable ring-type device that uses photoplethysmography-based technology to estimate continuous ambulatory blood pressure. Compared with conventional cuff-based ambulatory blood pressure monitoring, the device allows more comfortable long-term monitoring and may facilitate improved hypertension management.\n\nThis study is designed as a multicenter, prospective, open-label randomized controlled trial conducted at Korea University Anam Hospital, Korea University Guro Hospital, and Korea University Ansan Hospital. Adult patients with uncontrolled hypertension despite ongoing antihypertensive therapy will be enrolled and randomized to either CART BP Pro-guided management or usual care. In the intervention group, antihypertensive treatment adjustments will be guided by blood pressure information obtained from the CART BP Pro device. In the control group, treatment decisions will be based on conventional office blood pressure measurements according to standard clinical practice. Participants will be followed for 24 weeks to evaluate blood pressure control and safety outcomes. An optional extended follow-up to 48 weeks may be performed for additional observational analysis.\n\nThe study aims to determine whether CART BP Pro-guided blood pressure management improves ambulatory blood pressure control compared with usual care in real-world clinical practice.",[39,45],{"label":40,"type":41,"description":42,"interventionNames":43},"CART BP Pro-guided blood pressure management","EXPERIMENTAL","Participants will undergo ambulatory blood pressure monitoring using the CART BP Pro wearable device. Antihypertensive medication adjustments will be guided by ambulatory blood pressure data obtained from the device.",[44],"Device: CART BP Pro",{"label":46,"type":47,"description":48,"interventionNames":49},"Usual care","ACTIVE_COMPARATOR","Participants will receive standard hypertension management based on office blood pressure measurements according to current clinical guidelines.",[50],"Other: Usual Care",[52,57],{"type":53,"name":54,"description":55,"armGroupLabels":56,"otherNames":29},"DEVICE","CART BP Pro","CART BP Pro is a wearable cuffless continuous blood pressure monitoring device based on photoplethysmography technology that enables 24-hour ambulatory blood pressure measurement.",[40],{"type":6,"name":58,"description":59,"armGroupLabels":60,"otherNames":29},"Usual Care","Antihypertensive medication adjustments are based on office blood pressure measurements obtained during routine outpatient visits.",[46],[62],{"name":63,"role":64,"phone":65,"phoneExt":29,"email":66},"Hyung Joon Joo, MD PhD","CONTACT","+821034760526","drjoohj@korea.ac.kr",[68,86,112],{"facility":69,"status":70,"city":71,"state":29,"zip":29,"country":72,"countryCode":29,"cosmosGeoPoint":73,"geoPoint":78,"contacts":79},"Korea University Ansan Hospital","RECRUITING","Ansan","South Korea",{"type":74,"coordinates":75},"Point",[76,77],126.52613,35.46836,{"lat":77,"lon":76},[80,84],{"name":81,"role":64,"phone":82,"phoneExt":29,"email":83},"Seung Yong Shin, MD PhD","+82-1088631078","theshin04@korea.ac.kr",{"name":81,"role":85,"phone":29,"phoneExt":29,"email":29},"PRINCIPAL_INVESTIGATOR",{"facility":5,"status":70,"city":87,"state":29,"zip":88,"country":72,"countryCode":29,"cosmosGeoPoint":89,"geoPoint":93,"contacts":94},"Seoul","02841",{"type":74,"coordinates":90},[91,92],126.9784,37.566,{"lat":92,"lon":91},[95,98,99,102,104,106,108,110],{"name":96,"role":64,"phone":97,"phoneExt":29,"email":66},"Hyung Joon Joo","+82-1034760526",{"name":63,"role":85,"phone":29,"phoneExt":29,"email":29},{"name":100,"role":101,"phone":29,"phoneExt":29,"email":29},"Cheol Woong Yu, MD PhD","SUB_INVESTIGATOR",{"name":103,"role":101,"phone":29,"phoneExt":29,"email":29},"Dong-Hyuk Cho, MD PhD",{"name":105,"role":101,"phone":29,"phoneExt":29,"email":29},"Jung-Joon Cha, MD PhD",{"name":107,"role":101,"phone":29,"phoneExt":29,"email":29},"Mi-Na Kim, MD PhD",{"name":109,"role":101,"phone":29,"phoneExt":29,"email":29},"Jae Hyoung Park, MD PhD",{"name":111,"role":101,"phone":29,"phoneExt":29,"email":29},"Se Won Oh, MD PhD",{"facility":113,"status":70,"city":87,"state":29,"zip":29,"country":72,"countryCode":29,"cosmosGeoPoint":114,"geoPoint":116,"contacts":117},"Korea University Guro Hospital",{"type":74,"coordinates":115},[91,92],{"lat":92,"lon":91},[118,122,123],{"name":119,"role":64,"phone":120,"phoneExt":29,"email":121},"Soohyung Park, MD PhD","+82-1031053710","shp503@naver.com",{"name":119,"role":85,"phone":29,"phoneExt":29,"email":29},{"name":124,"role":101,"phone":29,"phoneExt":29,"email":29},"Ji Eun Lee, MD",{"type":85,"investigatorFullName":96,"investigatorTitle":126,"investigatorAffiliation":5,"oldNameTitle":29,"oldOrganization":29},"Professor",[128],{"name":129,"class":130},"Daewoong Pharmaceutical Co. LTD.","INDUSTRY","100628738",false,"NCT07465549","CART BP Pro-Guided Blood Pressure Management for Uncontrolled Hypertension","Efficacy and Safety of Cuffless Ambulatory Blood Pressure Monitoring Device-Guided Blood Pressure Management Compared With Usual Care in Korean Patients With Uncontrolled Hypertension: A Multicenter Prospective Randomized Controlled Trial","CART-BP RCT","Inclusion Criteria:\n\n1. Age ≥ 19 years\n2. Uncontrolled hypertension defined as office systolic blood pressure ≥ 140 mmHg or diastolic blood pressure ≥ 90 mmHg\n3. Ability and willingness to provide written informed consent and comply with study procedures\n\nExclusion Criteria:\n\n1. History of intolerance or contraindication to olmesartan, amlodipine, or hydrochlorothiazide\n2. Suspected secondary hypertension\n3. Atrial fibrillation\n4. Pregnancy or lactation\n5. Any serious medical condition that may interfere with study participation or interpretation of study results","ALL","19 Years",{"count":141,"type":142},400,"ESTIMATED","INTERVENTIONAL",[145],"NA","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.\n\nEligible 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.\n\nThe 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.",[148],"Hypertension",[148,150,151,152,54],"Ambulatory blood pressure monitoring","Cuffless blood pressure monitoring","Wearable blood pressure device","2026-04-26",{"date":155,"type":156},"2026-04-30","ACTUAL",{"date":158,"type":156},"2025-10-22",{"date":160,"type":142},"2027-07-31",{"name":5,"class":6},3]