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New treatment option for Hypertension (HTN)
Official title WEARABLE-BP: Wearable Everyday Automated Readings to Enable Assessment of Blood Pressure Control
ClinicalTrials.gov ID: NCT07523269
What this study is testing
- What it's testing
- 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.
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 21 to 85
You may be able to join if
- 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.
You likely can't join if
- 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).
See the full eligibility 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.
- 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 \ 42 cm.
- Wrist circumference \> 23 cm.
- Mastectomy
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 21 years to 85 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.