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Wearable BP monitor takes on the cuff in hypertension showdown

NCT ID NCT07523269

Disease control Sponsor: Aktiia SA Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study compares a wearable blood pressure monitor (Aktiia G1) to a traditional arm cuff in adults with uncontrolled high blood pressure. Over 6 months, researchers will see which method leads to better blood pressure control. Participants must have a smartphone and attend two clinic visits.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 164 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Apr 2026

An estimate. Start dates often move.

Expected to finish

Dec 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

21 to 85 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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. Exclusion Criteria: * 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). * 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

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder hypertensive disorder vascular disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Hypertension (HTN)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Mass General Brigham Hospital

    RECRUITING

    Boston, Massachusetts, 02115, United States

More trials for these conditions

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