164 Participants NeededMy employer runs this trial

Aktiia G1 BP Monitor for High Blood Pressure

(WEARABLE-BP Trial)

KH
Overseen ByKristen Harriott
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Aktiia SA
Must be taking: Antihypertensives
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

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

Own a smartphone with iOS or Android operating system
Hypertensive with uncontrolled systolic blood pressure (SBP) >135 mm Hg by unattended automated office measurement
Able to read and speak English
See 6 more

Exclusion Criteria

I have severe diabetes with a recent A1c over 10%.
I have very high blood pressure above 180/120 mmHg.
I have paralysis in my arm.
See 18 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants are assigned to either the Aktiia G1 BP monitor or a traditional BP monitor for a 6-month comparison period

6 months
Monthly virtual check-ins

Follow-up

All participants use the Aktiia G1 BP monitor for an additional 6-month follow-up period

6 months
Monthly virtual check-ins

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

Group I: Group 1: Aktiia G1 BP monitor (or "Hilo") - interventionExperimental Treatment1 Intervention
Group II: Group 2: Traditional BP monitor (upper arm cuff) - active controlActive Control1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Aktiia SA

Lead Sponsor

Trials
12
Recruited
23,600+

Massachusetts General Hospital

Collaborator

Trials
3,066
Recruited
13,430,000+

Brigham and Women's Hospital

Collaborator

Trials
1,694
Recruited
14,790,000+