Actively Recruiting

Phase Not Applicable
Age: 21Years - 85Years
All Genders
NCT07523269

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

Led by Aktiia SA · Updated on 2026-04-13

164

Participants Needed

1

Research Sites

87 weeks

Total Duration

On this page

Sponsors

A

Aktiia SA

Lead Sponsor

M

Massachusetts General Hospital

Collaborating Sponsor

AI-Summary

What this Trial Is About

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.

CONDITIONS

Official Title

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

Who Can Participate

Age: 21Years - 85Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Adults aged 21 to 85 years.
  • Able to read and speak English.
  • Have an MGB provider and medical record number in EPIC.
  • 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 above 135 mm Hg by unattended automated office measurement.
  • Currently taking 0, 1 or 2 antihypertensive medications.
Not Eligible

You will not qualify if you...

  • Severe hypertension (systolic blood pressure above 180 mmHg or diastolic blood pressure above 120 mmHg).
  • Pregnant or breastfeeding.
  • Known severe heart failure with left ventricular ejection fraction less than 35%.
  • Known severe valvular heart disease.
  • Known pheochromocytoma.
  • Known severe chronic kidney disease (stage 4-5) with estimated glomerular filtration rate less than 30 mL/min/1.73 m82.
  • Known uncontrolled hyperthyroidism or hypothyroidism.
  • Known severe diabetes with hemoglobin A1c above 10%.
  • Known resting heart rate above 120 beats per minute.
  • 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 pacemaker, defibrillator, intravascular device, or arteriovenous fistula.
  • Upper arm circumference less than 22 cm or greater than 42 cm.
  • Wrist circumference greater than 23 cm.
  • Mastectomy.

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

Mass General Brigham Hospital

Boston, Massachusetts, United States, 02115

Actively Recruiting

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Research Team

K

Kristen Harriott

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

OTHER

Number of Arms

2

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