Wearable tech may outsmart the blood pressure cuff in preventing heart attacks
NCT ID NCT07770477
First seen Aug 18, 2026 · Last updated Aug 19, 2026 · Updated 1 time
Summary
This trial compares two ways of managing high blood pressure: using a cuffless wearable device that tracks blood pressure continuously for 24 hours versus traditional office measurements. About 3,000 adults with high blood pressure will be randomly assigned to one of the two strategies. The goal is to see if the cuffless approach leads to fewer cardiovascular events like strokes, heart attacks, and heart failure.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Cuffless ambulatory blood pressure monitoring device
- What this could lead to
- If successful, this approach could improve blood pressure control and reduce the risk of heart attacks, strokes, and other cardiovascular events in people with hypertension.
- What could go wrong
- The trial is large but still experimental; the cuffless device may not be as accurate as traditional cuffs, and the benefit over standard care is not yet proven.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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About 3,000 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Dec 2036
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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30 to 79 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 24 hour mean SBP ≥ 130 mmHg by cuffless ambulatory BP monitor * aged ≥30 and \<80 years * voluntarily decide to participate in this clinical trial and provide written informed consent after being adequately informed. * willing and able to comply with the requirements of the study protocol Exclusion Criteria: * Did not agree with this clinical trial and did not provide informed consent * Office SBP ≥ 190 mmHg, or diastolic BP (DBP) \< 60 mmHg. * Diagnosed secondary hypertension. * Hospitalization for stroke, myocardial infarction (MI) or unstable angina within the last 6 months * Coronary revascularization (percutaneous coronary intervention \[PCI\] or coronary artery bypass grafting \[CABG\]) within the last 12 months. * Planned to perform coronary revascularization (PCI or CABG) in the next 12 months. * History of sustained atrial fibrillation (AF) or ventricular arrhythmias at entry influencing the BP measurement of ring-type cuffless BP monitoring device. * Severe valvular disease or valvular disease likely to require surgery or percutaneous valve replacement during the trial. * Underlying heart disease: Hypertrophic cardiomyopathy (HCM), dilated cardiomyopathy (DCM), rheumatic heart disease or congenital heart disease * Uncontrolled diabetes mellitus (serum fasting glucose \> 200 mg/dL or glycated hemoglobin \[HbA1c\] \>8%). * Severe liver dysfunction (alanine aminotransferase \[ALT\] \> 3 times the upper limit of normal (ULN) value). * Severe renal dysfunction (end stage renal disease \[ESRD\] on dialysis or estimated glomerular filtration rate \[eGFR\] \<30 ml/min/1.73m², or serum creatinine \>2.5 mg/dL. * Malignancy history within 5 years. * Severe cognitive impairment or mental disorders. * Participating in other clinical trials other than observation registry
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
9 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Korea University Anam Hospital
Seoul, South Korea
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Korea University Guro Hospital
Seoul, South Korea
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Kyung Hee University Hospital at Gangdong
Seoul, South Korea
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Kyungpook National University Hospital
Daegu, South Korea
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Seoul National University Boramae Medical Center
Seoul, South Korea
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Seoul National University Bundang Hospital
Seongnam-si, Gyeonggi-do, South Korea
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Seoul National University Hospital
Seoul, South Korea
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The Catholic University of Korea, Seoul St. Mary's Hospital
Seoul, South Korea
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The Catholic University of Korea, Uijeongbu St. Mary's Hospital
Uijeongbu-si, Gyeonggi-do, South Korea
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Could a quieter, automated blood pressure check help more people control hypertension?
- Can a phone call boost confidence in managing high blood pressure?
- Smart pillbox aims to keep patients on track
- Wristband vs. cuff: can a cuffless device match 24-Hour blood pressure monitoring?