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

Status: Recruiting
Location: See location...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 21
Maximum Age: 85
Healthy Volunteers: f
View:

• 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.

Locations
United States
Massachusetts
Mass General Brigham Hospital
RECRUITING
Boston
Contact Information
Primary
Kristen Harriott
BWHWearableBP@mgb.org
617-525-8493
Time Frame
Start Date: 2026-04
Estimated Completion Date: 2027-12
Participants
Target number of participants: 164
Treatments
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.
Related Therapeutic Areas
Sponsors
Collaborators: Brigham and Women's Hospital, Massachusetts General Hospital
Leads: Aktiia SA

This content was sourced from clinicaltrials.gov