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)
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 100
- Locations
- 1
- Primary Endpoint
- Agreement between CART-BP and ABPM in 24-hour mean systolic and diastolic blood pressure
Study Overview
Brief 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.
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.
Study Design
- Study Type
- Observational
- Observational Model
- Cohort
- Time Perspective
- Prospective
Eligibility Criteria
- Ages
- 19 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Arms & Interventions
Heart failure with reduced ejection fraction
Heart failure with reduced ejection fraction with or without hypertension
Outcomes
Primary Outcomes
Agreement between CART-BP and ABPM in 24-hour mean systolic and diastolic blood pressure
Time Frame: 24 hours
Agreement between the CART-BP ring-type device and the 24-hour ABPM for mean 24-hour systolic blood pressure (SBP) and diastolic blood pressure (DBP), evaluated according to ISO 81060-2:2018 Criteria 1 and 2 (Opposite arm simultaneous method, section 5.2.4.2.2)
Secondary Outcomes
- Blood pressure variability (standard deviation) agreement between devices(24 hours)
- Measurement adherence rate of ABPM (target: ≥ 80% valid readings in total enrolled patients)(24 hours)
- Measurement adherence rate of CART-BP (target: ≥ 80% valid readings in total enrolled patients)(24 hours)
- Agreement in nighttime mean SBP and DBP between CART-BP and ABPM(24 hours)
- Agreement in blood pressure dipping pattern between CART-BP and ABPM(24 hours)
- Agreement in daytime mean SBP and DBP between CART-BP and ABPM(24 hours)
Investigators
In-Cheol Kim
Associate Professor
Keimyung University Dongsan Medical Center