WEARABLE-BP: Wearable Everyday Automated Readings to Enable Assessment of Blood Pressure Control
Purpose
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.
Condition
- Hypertension (HTN)
Eligibility
- Eligible Ages
- Between 21 Years and 85 Years
- Eligible Sex
- All
- Accepts Healthy Volunteers
- No
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
- Phase
- N/A
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel Assignment
- Intervention Model Description
- prospective open-label 2-arm study
- Primary Purpose
- Other
- Masking
- None (Open Label)
Arm Groups
| Arm | Description | Assigned Intervention |
|---|---|---|
|
Experimental Group 1: Aktiia G1 BP monitor (or "Hilo") - intervention |
These participants will receive an Aktiia G1 BP monitor and wear it through the entire 12-month study period. |
|
|
Active Comparator Group 2: Traditional BP monitor (upper arm cuff) - active control |
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. |
|
Recruiting Locations
Boston, Massachusetts 02115
More Details
- Status
- Recruiting
- Sponsor
- Aktiia SA
Detailed Description
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.