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Recruiting NCT07523269

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

No phase Interventional Hypertension (HTN)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Aktiia G1 BP monitor for 12 months, Traditional BP monitor for 6 months / Aktiia G1 BP monitor for 6 months.
Who it may be relevant to
Registry conditions: Hypertension (HTN). Basic parameters: 21 years — 85 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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.

Interventions

  • Device Aktiia G1 BP monitor for 12 months
    These participants will receive an Aktiia G1 BP monitor and wear it through the entire 12-month study period.
  • Device Traditional BP monitor for 6 months / Aktiia G1 BP monitor for 6 months
    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.

Primary outcome measures

  • Change in automated unattended office BP between the two groups from baseline to 6 months [Time frame: 6 months]
Secondary outcome measures (3)
  • 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]

Eligibility criteria

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Open label
Primary purpose
Other

Study locations

United States · 1 center
  • Mass General Brigham Hospital — Boston

Identifiers

NCT: NCT07523269 · WEARABLE-BP

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗