Ring-style blood pressure bracelet test compared with 24-hour monitoring in people with HFrEF

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This observational, multi-center study in South Korea compares a ring-based BP device that uses photoplethysmography (PPG) to the conventional 24-hour ABPM. Fifty? No, 100 patients will be enrolled to measure BP over a full day and assess agreement with ISO 81060-2:2018 criteria for mean, daytime, and nighttime values. An interim analysis after 40 participants will determine whether to continue to the full enrollment. The study focuses on ensuring accuracy in a population where BP readings can be challenging due to reduced cardiac output and vascular changes.

Why it matters

Who can join: the full rules

Inclusion Criteria:

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

Exclusion Criteria:

1. Office blood pressure: SBP \< 90 mmHg, or DBP \< 50 mmHg, or SBP \> 180 mmHg, or DBP \> 100 mmHg
2. Unable to perform 24-hour ambulatory blood pressure monitoring
3. Unable to wear or use the ring-type blood pressure device
4. Variability in three consecutive resting cuff blood pressure measurements ≥ 20 mmHg (SBP) or ≥ 10 mmHg (DBP)
5. 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
6. Pregnant, suspected pregnancy, or breastfeeding
7. Judged by the investigator to be legally or mentally unfit to participate in the clinical study

Where it's running

• Keimyung University Dongsan Medical Center
  Daegu, South Korea Recruiting

Study contacts

• Study coordinator: In-Cheol Kim
• Email: kimic@dsmc.or.kr
• Phone: 82-53-258-4629

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.