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Recruiting NCT07626879

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

— Observational Heart Failure With Reduced Ejection Fraction; Hypertension

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
This is an observational study: the protocol does not assign a study treatment.
Who it may be relevant to
Registry conditions: Heart Failure With Reduced Ejection Fraction; Hypertension. Basic parameters: from 19 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
South Korea
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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)

Overview

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.

Detailed description

Hypertension is a major risk factor and exacerbating cause of heart failure. Accurate blood pressure monitoring in HFrEF patients is critically important, as reduced left ventricular stroke volume and altered peripheral vascular hemodynamics may affect the accuracy of photoplethysmography (PPG)-based blood pressure measurement.

The CART-BP device uses PPG technology in a ring form factor to enable continuous, non-invasive blood pressure monitoring. This study will simultaneously measure blood pressure using CART-BP and standard 24-hour ABPM over a 24-hour period. Agreement will be assessed using ISO 81060-2:2018 Criteria 1 and 2. An interim analysis will be conducted after 40 participants are enrolled to assess preliminary agreement and determine whether to continue to the full enrollment of 100 participants.

Primary outcome measures

  • Agreement between CART-BP and ABPM in 24-hour mean systolic and diastolic blood pressure [Time frame: 24 hours]
Secondary outcome measures (6)
  • Agreement in daytime mean SBP and DBP between CART-BP and ABPM [Time frame: 24 hours]
  • Agreement in nighttime mean SBP and DBP between CART-BP and ABPM [Time frame: 24 hours]
  • Agreement in blood pressure dipping pattern between CART-BP and ABPM [Time frame: 24 hours]
  • Blood pressure variability (standard deviation) agreement between devices [Time frame: 24 hours]
  • Measurement adherence rate of ABPM (target: ≥ 80% valid readings in total enrolled patients) [Time frame: 24 hours]
  • Measurement adherence rate of CART-BP (target: ≥ 80% valid readings in total enrolled patients) [Time frame: 24 hours]

Eligibility criteria

Inclusion criteria

  • 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 criteria

  • 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

South Korea · 1 center
  • Keimyung University Dongsan Medical Center — Daegu

Identifiers

NCT: NCT07626879 · 2025-10-039-005

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗