WEARABLE-BP: Wearable Everyday Automated Readings to Enable Assessment of Blood Pressure Control

Recruiting now · Not applicable

Conditions studied: Hypertension (HTN)

In brief

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.

Key facts

Study ID

NCT07523269

Run by

Aktiia SA

People needed

164

Starts

2026-04-01

Expected to finish

2027-12-01

Last updated by the study team

2026-04-13

Who can join

Age: 21 and older, up to 85. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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

Where it is running

• Mass General Brigham Hospital — Boston, Massachusetts, United States (enrolling)

Full record on ClinicalTrials.gov

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