Validation Study of CART BP as a Wearable Cuffless Blood Pressure Monitor

NCT06513975 | Recruiting

• 1 other identifier: SL_BP_V1.0
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to evaluate the accuracy of the CART BP, a medically approved ring-type blood pressure monitor, in comparison to the traditional auscultatory method using a dual-head stethoscope. The comparison is conducted in accordance with the 2023 European Society of Hypertension (ESH) Recommendations, focusing on patients with suspected hypertension or hypotension. The evaluation includes accuracy measurements across various postures and during different exercise periods.

Conditions

Blood Pressure; Hypertension; Blood Pressure, High; Blood Pressure, Low; Hypotension

Outcome Measures

Primary Outcomes (1)

• Mean error and standard deviations of differences between CART BP and Reference

  The primary outcome measure is the mean error and standard deviation (SD) of the differences between the CART BP device and the reference device. This endpoint is determined based on the European Hypertension Society (ESH) recommendation, which states that the pass criteria are as per International Organization for Standardization (ISO) 81060-2:2018: a mean error within 5 mmHg and an standard deviation within ±8 mmHg.

  1 hour

Study Arms (1)

Subjects requiring 24-hour ambulatory blood pressure monitoring

EXPERIMENTAL

Subjects prescribed for ambulatory blood pressure monitor (ABPM) measure 24-hour blood pressure using both the CART BP and sphygmomanometer

Device: CART BP; Device: sphygmomanometer

Interventions

CART BP DEVICE

A ring-type medical device worn by the subject that non-invasively measures systolic and diastolic blood pressure, as well as pulse rate.

Subjects requiring 24-hour ambulatory blood pressure monitoring

sphygmomanometer DEVICE

Blood pressure measurement method utilizing a two-headed stethoscope, allowing two observers to simultaneously hear the Korotkoff sounds.

Subjects requiring 24-hour ambulatory blood pressure monitoring

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Subjects aged 18 years or older but younger than 80 years
• Individuals who voluntarily decide to participate in this clinical trial and provide written consent to the information and consent form
• Individuals willing to comply with the clinical trial protocol

You may not qualify if:

• Subjects who do not consent to the study
• Obese individuals with a Body Mass Index (BMI) of 30 or higher (concerns about measurement errors as the standard 24-hour ambulatory blood pressure monitor cuff may not fit the arm properly)
• Patients or volunteers who are pregnant
• Patients or volunteers with underlying heart diseases: those with a history of hospitalization for heart failure, valvular disease, or myocardial infarction
• Patients or volunteers diagnosed with atrial fibrillation on a 12-lead electrocardiogram (ECG) within the past 6 months
• Patients or volunteers with end-stage renal disease (undergoing dialysis)
• Patients or volunteers unable to perform repeated exercises required for the study
• Patients or volunteers with a systolic blood pressure (SBP) exceeding 160 millimeters of mercury (mmHg)
• Patients or volunteers with a systolic blood pressure (SBP) exceeding 160 millimeters of mercury (mmHg) and/or a diastolic blood pressure (DBP) exceeding 100 millimeters of mercury (mmHg) (for exercise tests)

Sponsors & Collaborators

• Sky Labs: lead
• Samsung Medical Center: collaborator

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

RECRUITING

Related Publications (4)

• Carey RM, Muntner P, Bosworth HB, Whelton PK. Prevention and Control of Hypertension: JACC Health Promotion Series. J Am Coll Cardiol. 2018 Sep 11;72(11):1278-1293. doi: 10.1016/j.jacc.2018.07.008.

  PMID: 30190007 BACKGROUND

• Stergiou GS, Avolio AP, Palatini P, Kyriakoulis KG, Schutte AE, Mieke S, Kollias A, Parati G, Asmar R, Pantazis N, Stamoulopoulos A, Asayama K, Castiglioni P, De La Sierra A, Hahn JO, Kario K, McManus RJ, Myers M, Ohkubo T, Shroff SG, Tan I, Wang J, Zhang Y, Kreutz R, O'Brien E, Mukkamala R. European Society of Hypertension recommendations for the validation of cuffless blood pressure measuring devices: European Society of Hypertension Working Group on Blood Pressure Monitoring and Cardiovascular Variability. J Hypertens. 2023 Dec 1;41(12):2074-2087. doi: 10.1097/HJH.0000000000003483. Epub 2023 Jun 22.

  PMID: 37303198 BACKGROUND

• Kario K, Shin J, Chen CH, Buranakitjaroen P, Chia YC, Divinagracia R, Nailes J, Hoshide S, Siddique S, Sison J, Soenarta AA, Sogunuru GP, Tay JC, Teo BW, Turana Y, Zhang Y, Park S, Van Minh H, Wang JG. Expert panel consensus recommendations for ambulatory blood pressure monitoring in Asia: The HOPE Asia Network. J Clin Hypertens (Greenwich). 2019 Sep;21(9):1250-1283. doi: 10.1111/jch.13652.

  PMID: 31532913 BACKGROUND

• O'Brien E, Parati G, Stergiou G, Asmar R, Beilin L, Bilo G, Clement D, de la Sierra A, de Leeuw P, Dolan E, Fagard R, Graves J, Head GA, Imai Y, Kario K, Lurbe E, Mallion JM, Mancia G, Mengden T, Myers M, Ogedegbe G, Ohkubo T, Omboni S, Palatini P, Redon J, Ruilope LM, Shennan A, Staessen JA, vanMontfrans G, Verdecchia P, Waeber B, Wang J, Zanchetti A, Zhang Y; European Society of Hypertension Working Group on Blood Pressure Monitoring. European Society of Hypertension position paper on ambulatory blood pressure monitoring. J Hypertens. 2013 Sep;31(9):1731-68. doi: 10.1097/HJH.0b013e328363e964.

  PMID: 24029863 BACKGROUND

MeSH Terms

Conditions

Hypertension; Hypotension

Interventions

Sphygmomanometers

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Equipment; Equipment and Supplies

Study Officials

• Seung Woo Park

  Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Gerrard Kim

CONTACT

+82-10-5192-8767; gerrard.kim@skylabs.io

Yujung Kang

CONTACT

+82-10-9764-7432; yujung.kang@skylabs.io

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 16, 2024
• First Posted: July 23, 2024
• Study Start: November 22, 2024
• Primary Completion: August 15, 2025
• Study Completion: August 15, 2025
• Last Updated: June 15, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)