WEARABLE-BP: Wearable Everyday Automated Readings to Enable Assessment of Blood Pressure Control
Aktiia SA
164 participants
Apr 1, 2026
INTERVENTIONAL
Conditions
Summary
The WEARABLE-BP study will evaluate the clinical value of obtaining continual measurements using the Aktiia G1 Optical Blood Pressure Monitoring (OBPM) device in hypertensive patients, compared to using a traditional upper arm cuff for home BP monitoring. The WEARABLE-BP study aims to compare the change in unattended automated office blood pressure from baseline to 6 months between two study groups: those given an Aktiia G1 BP monitor and those given a traditional upper arm BP cuff.
Eligibility
Inclusion Criteria9
- Adults aged 21 to 85 years.
- Able to read and speak English.
- Have an MGB provider and medical record number in EPIC
- Study participants will wear the Aktiia bracelet for 6 months
- Willing to attend two on-site study visits and comply with all study procedures.
- Signed informed consent provided.
- Own a smartphone with iOS or Android operating system.
- Hypertensive with uncontrolled systolic blood pressure (SBP) >135 mm Hg by unattended automated office measurement
- Currently taking 0, 1 or 2 antihypertensive medications.
Exclusion Criteria21
- Severe hypertension (SBP > 180 mmHg or DBP > 120 mmHg).
- Pregnant or breastfeeding.
- Known severe heart failure (LVEF < 35%).
- Known severe valvular heart disease.
- Known pheochromocytoma.
- Known severe chronic kidney disease (CKD stage 4-5; eGFR < 30 mL/min/1.73 m²).
- Known uncontrolled hyperthyroidism or hypothyroidism.
- Known severe diabetes (Hemoglobin A1c > 10%).
- Known resting heart rate > 120 bpm.
- Known persistent atrial fibrillation.
- Known Raynaud's disease.
- Known tremors or shivering disorders.
- Known exfoliative skin diseases.
- Known allergy to silicone.
- Presence of lymphedema.
- Paralysis of the arm.
- Arm amputation.
- Presence of implanted devices, such as a pacemaker, defibrillator, intravascular device, or arteriovenous fistula.
- Upper arm circumference < 22 cm or > 42 cm.
- Wrist circumference > 23 cm.
- Mastectomy
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Interventions
These participants will receive an Aktiia G1 BP monitor and wear it through the entire 12-month study period.
These participants will receive a traditional BP monitor (validated upper arm cuff) to use for the 6 months comparison period. At the 6-month visit, they will return the traditional BP monitor and receive an Aktiia G1 BP monitor for the 6-month follow-up period.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07523269