Aktiia G1 BP Monitor for High Blood Pressure
(WEARABLE-BP Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
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.
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants are assigned to either the Aktiia G1 BP monitor or a traditional BP monitor for a 6-month comparison period
Follow-up
All participants use the Aktiia G1 BP monitor for an additional 6-month follow-up period
What Are the Treatments Tested in This Trial?
Interventions
- Aktiia G1 BP monitor
How Is the Trial Designed?
2
Treatment groups
Experimental Treatment
Active Control
These participants will receive an Aktiia G1 BP monitor and wear it through the entire 12-month study period.
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.
Find a Clinic Near You
Who Is Running the Clinical Trial?
Aktiia SA
Lead Sponsor
Massachusetts General Hospital
Collaborator
Brigham and Women's Hospital
Collaborator
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