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

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

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.

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.

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