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

NCT07523269 · Aktiia SA

Recruiting

In plain English

Click the button to translate this study into plain language — what it is, who qualifies, and what participation looks like.

About this study

This is a prospective open-label two-arm randomized clinical trial (RCT). The investigational device of this study is the Aktiia G1 BP monitor. There is an active 6- month comparison period between two BP monitoring devices, followed by a 6-month follow-up period when all patients will have an Aktiia G1 BP monitor. Each participant will be randomly assigned to one of two study groups: Group 1, or Group 2. The randomization will be a simple, based on a single computer-generated sequence of random assignments. * Group 1: Aktiia G1 BP monitor (or "Hilo") - intervention 82 participants. These participants will receive an Aktiia G1 BP monitor and wear it through the entire 12-month study period. * Group 2: Traditional BP monitor (upper arm cuff) - active control 82 participants. 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. During the study, the patient completes online survey covering lifestyle, health, and socioeconomic environment.

Eligibility criteria

Inclusion Criteria: * 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 Criteria: * 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

Study design

Enrollment target: 164 participants

Allocation: randomized

Masking: none

Age groups: adult, older_adult

Timeline

Starts: 2026-04

Estimated completion: 2027-12

Last updated: 2026-04-13

Interventions

Device: Aktiia G1 BP monitor for 12 monthsDevice: Traditional BP monitor for 6 months / Aktiia G1 BP monitor for 6 months

Primary outcomes

• Change in automated unattended office BP between the two groups from baseline to 6 months (6 months)

Sponsor

Aktiia SA · industry

With: Massachusetts General Hospital, Brigham and Women's Hospital

Contacts & investigators

ContactKristen Harriott · contact · BWHWearableBP@mgb.org · 617-525-8493

All locations (1)

Mass General Brigham HospitalRecruiting

Boston, Massachusetts, United States

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