WEARABLE-BP: Wearable Everyday Automated Readings to Enable Assessment of Blood Pressure Control
Recruiting · NCT07523269 · Interventional (participants receive a specific treatment) · Lead sponsor: Aktiia SA
View the official record on ClinicalTrials.gov →Interventions studied
Aktiia G1 BP monitor for 12 monthsTraditional BP monitor for 6 months / Aktiia G1 BP monitor for 6 months
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.
Who can take part
Age range
21 Years to 85 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
1 location listed across 1 US state.
- Mass General Brigham Hospital - Boston, Massachusetts, United States