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Feasibility and Effectiveness of a Ring-Type Blood Pressure Device (CART-BP) Compared With 24-Hour Ambulatory Blood Pressure Monitoring in HFrEF

Feasibility and Effectiveness of a RING-type Blood Pressure Measurement Device (CART-BP) Compared With 24-Hour Ambulatory Blood Pressure Monitoring Device in Patients With Heart Failure With Reduced Ejection Fraction (RING-HFrEF)

Sponsor

Keimyung University Dongsan Medical Center

Enrollment

100 participants

Start Date

Oct 23, 2025

Study Type

OBSERVATIONAL

Conditions

Heart Failure With Reduced Ejection Fraction; Hypertension

Summary

This study aims to evaluate the feasibility and diagnostic accuracy of the CART-BP ring-type wearable blood pressure monitoring device in comparison with 24-hour ambulatory blood pressure monitoring (ABPM) in patients with heart failure with reduced ejection fraction (HFrEF, LVEF ≤ 40%). As a multi-center, prospective, exploratory study, 100 patients will be enrolled at two tertiary hospitals in South Korea. The agreement between the two devices in 24-hour mean, daytime, and nighttime blood pressure measurements will be assessed per ISO 81060-2:2018 criteria.

Eligibility

Min Age: 19 Years

Inclusion Criteria5

  • Age ≥ 19 years (male or female)
  • Diagnosed with heart failure and currently under treatment
  • Left ventricular ejection fraction (LVEF) ≤ 40% confirmed by echocardiography performed within 1 year prior to enrollment
  • Able to undergo both 24-hour ambulatory blood pressure monitoring and ring-type blood pressure measurement
  • Voluntarily provided written informed consent to participate in this clinical study

Exclusion Criteria7

  • Office blood pressure: SBP < 90 mmHg, or DBP < 50 mmHg, or SBP > 180 mmHg, or DBP > 100 mmHg
  • Unable to perform 24-hour ambulatory blood pressure monitoring
  • Unable to wear or use the ring-type blood pressure device
  • Variability in three consecutive resting cuff blood pressure measurements ≥ 20 mmHg (SBP) or ≥ 10 mmHg (DBP)
  • Insufficient valid ABPM readings: < 25 daytime or < 12 nighttime measurements per ESH criteria; or < 25 daytime or < 12 nighttime valid readings from the ring-type device
  • Pregnant, suspected pregnancy, or breastfeeding
  • Judged by the investigator to be legally or mentally unfit to participate in the clinical study

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Locations(1)

Keimyung University Dongsan Medical Center

Daegu, South Korea

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NCT07626879