Heart Failure With Reduced Ejection Fraction; HypertensionRING-HFrEFNCT07626879
Feasibility and Effectiveness of a Ring-Type Blood Pressure Device (CART-BP) Compared With 24-Hour Ambulatory Blood Pressure Monitoring in HFrEF
An observational study of Heart Failure With Reduced Ejection Fraction; Hypertension, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
Trial 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%). Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Heart Failure With Reduced Ejection Fraction; Hypertension
- How many people
- 100 participants
- Where
- 1 siteSouth Korea
- Study dates
- 23 Oct 2025to 22 Oct 2026
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Heart Failure with Reduced Ejection Fraction patients
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
South Korea1 site, 1 recruiting
- Recruiting
Keimyung University Dongsan Medical Center
Daegu, 42601
Hyemin Kwon, 82-53-258-6691, irbdsmc@naver.com
About this study
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)
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.
Read the 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.
- Keywords
- HFrEF, ambulatory blood pressure monitoring, ABPM, wearable device, ring-type blood pressure, photoplethysmography, PPG, blood pressure validation
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Heart failure with reduced ejection fraction | Heart failure with reduced ejection fraction with or without hypertension |
What is being measured
The primary outcome is the main question the study is designed to answer.
Agreement between CART-BP and ABPM in 24-hour mean systolic and diastolic blood pressure
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)
Measured: 24 hours
Secondary outcomes (6)
Agreement in daytime mean SBP and DBP between CART-BP and ABPM
Measured: 24 hours
Agreement in nighttime mean SBP and DBP between CART-BP and ABPM
Measured: 24 hours
Agreement in blood pressure dipping pattern between CART-BP and ABPM
Measured: 24 hours
Blood pressure variability (standard deviation) agreement between devices
Measured: 24 hours
Measurement adherence rate of ABPM (target: ≥ 80% valid readings in total enrolled patients)
Measured: 24 hours
Measurement adherence rate of CART-BP (target: ≥ 80% valid readings in total enrolled patients)
Measured: 24 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2026
- Study start23 Oct 2025
- Primary completion22 Oct 2026 (estimated)
- Study completion22 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart Failure With Reduced Ejection Fraction; HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Keimyung University Dongsan Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, In-Cheol Kim, Keimyung University Dongsan Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07626879
- Sponsor's protocol ID
- 2025-10-039-005
- Acronym
- RING-HFrEF
- Status last verified
- Nov 2025
- First submitted
- 29 May 2026
- Last updated
- 4 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 4 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT07626879
- Acronym / sponsor ID
- RING-HFrEF / 2025-10-039-005
- Keywords
- HFrEF, ambulatory blood pressure monitoring, ABPM, wearable device, ring-type blood pressure, photoplethysmography, PPG, blood pressure validation
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Keimyung University Dongsan Medical CenterUniversity, hospital or other
- Study start
- 23 Oct 2025 (actual)
- Primary completion
- 22 Oct 2026 (estimated)
- Study completion
- 22 Oct 2026 (estimated)
- First posted
- 4 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Heart failure with reduced ejection fraction | – | –Heart failure with reduced ejection fraction with or without hypertension |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Heart Failure with Reduced Ejection Fraction patients
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
6 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Jun 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure With Reduced Ejection Fraction; Hypertension, run by Keimyung University Dongsan Medical Center at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 4 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact In-Cheol Kim (82-53-258-4629, kimic@dsmc.or.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Agreement between CART-BP and ABPM in 24-hour mean systolic and diastolic blood pressure (time frame: 24 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.