Health TrialsbyHealthPanel

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

ConditionHypertension (HTN)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-85
SponsorAktiia SA

About 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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

Severe hypertension (SBP > 180 mmHg or DBP > 120 mmHg).

Pregnant or breastfeeding.

Known severe heart failure (LVEF < 35%).

Known severe valvular heart disease.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Aktiia G1 BP monitor for 12 months

    Device

    These participants will receive an Aktiia G1 BP monitor and wear it through the entire 12-month study period.

  • Traditional BP monitor for 6 months / Aktiia G1 BP monitor for 6 months

    Device

    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.

Treatment groups

164 Participants
are divided into 2 treatment groups
Group A: Group 1: Aktiia G1 BP monitor (or "Hilo") - interventionExperimental treatment 1 intervention
Group B: Group 2: Traditional BP monitor (upper arm cuff) - active controlActive comparator 1 intervention

Trial outcomes

Primary outcomes

1

Change in automated unattended office BP between the two groups from baseline to 6 months

Comparison of change in automated unattended office BP (average over triplicate consecutive measurements) from baseline to 6 months between the two groups: those given an Aktiia G1 BP monitor and those given a traditional upper arm BP cuff.

Time frame
6 months

Secondary outcomes

1

Percentage of hypertensive subjects achieving BP control at 6 months in the intervention group compared to the standard treatment group

Percentage of hypertensive subjects achieving BP control at 6 months in the intervention group (Aktiia G1 BP monitor) compared to the standard treatment group (traditional upper arm cuff), defined by unattended automated office SBP \<130 mm Hg.

Time frame
6 months
2

Difference in patient engagement and lifestyle features between the 2 groups

To test if there is a difference in patient engagement and lifestyle features between the group given an Aktiia G1 BP monitor, and those given a traditional upper arm cuff, at baseline, 6 months and 12 months based on a questionnaire

Time frame
0, 6 and 12 months
3

Difference in mean average Aktiia G1 BP measurement after a 6-month period

To compare the difference in mean average Aktiia G1 BP measurement between the first week and the last week of the six-month comparison period in the intervention group to the difference in mean Aktiia G1 BP measurement between the first and the last week of the follow-up period for the active control group.

Time frame
6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Aktiia SA

Lead sponsor

Massachusetts General Hospital

Collaborator

Brigham and Women's Hospital

Collaborator

Source ClinicalTrials.gov
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