Hypertension (HTN)WEARABLE-BPNCT07523269
WEARABLE-BP: Wearable Everyday Automated Readings to Enable Assessment of Blood Pressure Control
A study testing Aktiia G1 BP monitor for 12 months and Traditional BP monitor for 6 months / Aktiia G1 BP monitor for 6 months in people with Hypertension (HTN), run by Aktiia SA at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Hypertension (HTN)
- What is being tested?
- Aktiia G1 BP monitor for 12 months and Traditional BP monitor for 6 months / Aktiia G1 BP monitor for 6 months
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 164 participants
- Where
- 1 siteUnited States
- Study dates
- Apr 2026to Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Show all 9Show fewer
- 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.
Who cannot join
- Severe hypertension (SBP > 180 mmHg or DBP > 120 mmHg).
- Pregnant or breastfeeding.
- Known severe heart failure (LVEF < 35%).
- Known severe valvular heart disease.
- Known pheochromocytoma.
- Known severe chronic kidney disease (CKD stage 4-5; eGFR < 30 mL/min/1.73 m²).
Show all 21Show fewer
- Known uncontrolled hyperthyroidism or hypothyroidism.
- Known severe diabetes (Hemoglobin A1c > 10%).
- Known resting heart rate > 120 bpm.
- Known persistent atrial fibrillation.
- Known Raynaud's disease.
- Known tremors or shivering disorders.
- Known exfoliative skin diseases.
- Known allergy to silicone.
- Presence of lymphedema.
- Paralysis of the arm.
- Arm amputation.
- Presence of implanted devices, such as a pacemaker, defibrillator, intravascular device, or arteriovenous fistula.
- Upper arm circumference < 22 cm or > 42 cm.
- Wrist circumference > 23 cm.
- Mastectomy
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Mass General Brigham Hospital
Boston, Massachusetts, 02115
Kristen Harriott, 617-525-8493, BWHWearableBP@mgb.org
Dr. Naomi Fisher, MD
About this study
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.
Read the detailed description
This is a prospective open-label two-arm randomized clinical trial (RCT). The investigational device of this study is the Aktiia G1 BP monitor.
There is an active 6- month comparison period between two BP monitoring devices, followed by a 6-month follow-up period when all patients will have an Aktiia G1 BP monitor.
Each participant will be randomly assigned to one of two study groups: Group 1, or Group 2. The randomization will be a simple, based on a single computer-generated sequence of random assignments.
- Group 1: Aktiia G1 BP monitor (or "Hilo") - intervention 82 participants. These participants will receive an Aktiia G1 BP monitor and wear it through the entire 12-month study period.
- Group 2: Traditional BP monitor (upper arm cuff) - active control 82 participants. 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.
During the study, the patient completes online survey covering lifestyle, health, and socioeconomic environment.
- Conditions
- Hypertension (HTN)
- Being tested
- Aktiia G1 BP monitor for 12 months, Traditional BP monitor for 6 months / Aktiia G1 BP monitor for 6 months
- Keywords
- Vascular Diseases, Cardiovascular Diseases, Hypertension
- Medical subject headings
- Hypertension, Vascular Diseases, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Aktiia G1 BP monitor for 12 monthsDevice
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 monthsDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Group 1: Aktiia G1 BP monitor (or "Hilo") - intervention | Experimental | These participants will receive an Aktiia G1 BP monitor and wear it through the entire 12-month study period. Receives: Device: Aktiia G1 BP monitor for 12 months |
| Group 2: Traditional BP monitor (upper arm cuff) - active control | Active comparator | 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. Receives: Device: Traditional BP monitor for 6 months / Aktiia G1 BP monitor for 6 months |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 6 months
Secondary outcomes (3)
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.
Measured: 6 months
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
Measured: 0, 6 and 12 months
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.
Measured: 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Apr 2026
- Study startApr 2026 (estimated)
- Primary completionSep 2027 (estimated)
- Study completionDec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Hypertension (HTN)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- prospective open-label 2-arm study
- Masking
- None (open label)
- Enrolment
- 164 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aktiia SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital, Brigham and Women's Hospital
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07523269
- Sponsor's protocol ID
- WEARABLE-BP
- Acronym
- WEARABLE-BP
- Status last verified
- Apr 2026
- First submitted
- 30 Mar 2026
- Last updated
- 13 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 13 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- WEARABLE-BP: Wearable Everyday Automated Readings to Enable Assessment of Blood Pressure Control
- ClinicalTrials.gov ID
- NCT07523269
- Acronym / sponsor ID
- WEARABLE-BP / WEARABLE-BP
- Conditions
- Hypertension (HTN)
- Keywords
- Vascular Diseases, Cardiovascular Diseases, Hypertension
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- Aktiia SAIndustry (pharma, biotech, devices)
- Collaborators
- Massachusetts General Hospital, Brigham and Women's Hospital
- Study start
- Apr 2026 (estimated)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2027 (estimated)
- First posted
- 13 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a prospective open-label two-arm randomized clinical trial (RCT). The investigational device of this study is the Aktiia G1 BP monitor.
There is an active 6- month comparison period between two BP monitoring devices, followed by a 6-month follow-up period when all patients will have an Aktiia G1 BP monitor.
Each participant will be randomly assigned to one of two study groups: Group 1, or Group 2. The randomization will be a simple, based on a single computer-generated sequence of random assignments.
- Group 1: Aktiia G1 BP monitor (or "Hilo") - intervention 82 participants. These participants will receive an Aktiia G1 BP monitor and wear it through the entire 12-month study period.
- Group 2: Traditional BP monitor (upper arm cuff) - active control 82 participants. 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.
During the study, the patient completes online survey covering lifestyle, health, and socioeconomic environment.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- prospective open-label 2-arm study
| Arm | Type | Receives |
|---|---|---|
| Group 1: Aktiia G1 BP monitor (or "Hilo") - intervention | Experimental | Device: Aktiia G1 BP monitor for 12 monthsThese participants will receive an Aktiia G1 BP monitor and wear it through the entire 12-month study period. |
| Group 2: Traditional BP monitor (upper arm cuff) - active control | Active comparator | Device: Traditional BP monitor for 6 months / Aktiia G1 BP monitor for 6 monthsThese 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. |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (21 listed)
- Severe hypertension (SBP > 180 mmHg or DBP > 120 mmHg).
- Pregnant or breastfeeding.
- Known severe heart failure (LVEF < 35%).
- Known severe valvular heart disease.
- Known pheochromocytoma.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Aktiia G1 BP monitor for 12 monthsThese participants will receive an Aktiia G1 BP monitor and wear it through the entire 12-month study period. | Device | Group 1: Aktiia G1 BP monitor (or "Hilo") - intervention |
| Traditional BP monitor for 6 months / Aktiia G1 BP monitor for 6 monthsThese 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. | Device | Group 2: Traditional BP monitor (upper arm cuff) - active control |
Primary outcome
Change in automated unattended office BP between the two groups from baseline to 6 months
Time frame: 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.
3 secondary outcomes
Percentage of hypertensive subjects achieving BP control at 6 months in the intervention group compared to the standard treatment group
Time frame: 6 months
Difference in patient engagement and lifestyle features between the 2 groups
Time frame: 0, 6 and 12 months
Difference in mean average Aktiia G1 BP measurement after a 6-month period
Time frame: 6 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Hypertension (HTN)
Active, not recruiting
Digital Reinforcement of Motivational Interviewing Micro-Skills Among Primary Care Healthcare Professionals
Hypertension (Without Type 2 Diabetes Mellitus)
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Recruiting
Trial Phase: Syndemic Adapted Medly Uganda
Mental Health
Not yet recruitingPhase 2/3
An Open-Label Extension Study to Evaluate Inhaled Treprostinil SMI in Participants With Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease (PH-COPD)
Pulmonary Hypertension Associated With Chronic Obstructive Pulmonary Disease
Enrolling by invitation
Testing Implementation Strategies to Support Clinic Fidelity to an Outpatient Hypertension Bundle
Pregnancy Related, Hypertension
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Aktiia G1 BP monitor for 12 months and Traditional BP monitor for 6 months / Aktiia G1 BP monitor for 6 months in people with Hypertension (HTN), run by Aktiia SA at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 21 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Apr 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kristen Harriott (617-525-8493, BWHWearableBP@mgb.org), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in automated unattended office BP between the two groups from baseline to 6 months (time frame: 6 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Apr 2026.