WEARABLE-BP: Wearable Everyday Automated Readings to Enable Assessment of Blood Pressure Control
NCT07523269 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 164
Last updated 2026-04-13
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.
Conditions
- Hypertension (HTN)
Interventions
- DEVICE
-
Aktiia G1 BP monitor for 12 months
These participants will receive an Aktiia G1 BP monitor and wear it through the entire 12-month study period.
- DEVICE
-
Traditional BP monitor for 6 months / Aktiia G1 BP monitor for 6 months
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.
Sponsors & Collaborators
-
Massachusetts General Hospital
collaborator OTHER -
Brigham and Women's Hospital
collaborator OTHER -
Aktiia SA
lead INDUSTRY
Study Design
- Allocation
- RANDOMIZED
- Purpose
- OTHER
- Masking
- NONE
- Model
- PARALLEL
Eligibility
- Min Age
- 21 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2026-04-30
- Primary Completion
- 2027-09-30
- Completion
- 2027-12-31
- FDA Device
- Yes
Countries
- United States
Study Locations
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