NCT07523269

Brief Summary

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
164

participants targeted

Target at P75+ for not_applicable

Timeline
19mo left

Started Apr 2026

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Progress3%
Apr 2026Dec 2027

First Submitted

Initial submission to the registry

March 30, 2026

Completed
2 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
12 days until next milestone

First Posted

Study publicly available on registry

April 13, 2026

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2027

Expected
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

April 13, 2026

Status Verified

April 1, 2026

Enrollment Period

1.4 years

First QC Date

March 30, 2026

Last Update Submit

April 8, 2026

Conditions

Hypertension (HTN)

Keywords

Vascular DiseasesCardiovascular DiseasesHypertension

Outcome Measures

Primary Outcomes (1)

  • Change in automated unattended office BP between the two groups from baseline to 6 months

    Comparison of change in automated unattended office BP (average over triplicate consecutive measurements) from baseline to 6 months between the two groups: those given an Aktiia G1 BP monitor and those given a traditional upper arm BP cuff.

    6 months

Secondary Outcomes (3)

  • Percentage of hypertensive subjects achieving BP control at 6 months in the intervention group compared to the standard treatment group

    6 months

  • Difference in patient engagement and lifestyle features between the 2 groups

    0, 6 and 12 months

  • Difference in mean average Aktiia G1 BP measurement after a 6-month period

    6 months

Study Arms (2)

Group 1: Aktiia G1 BP monitor (or "Hilo") - intervention

EXPERIMENTAL

These participants will receive an Aktiia G1 BP monitor and wear it through the entire 12-month study period.

Device: Aktiia G1 BP monitor for 12 months

Group 2: Traditional BP monitor (upper arm cuff) - active control

ACTIVE COMPARATOR

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.

Device: Traditional BP monitor for 6 months / Aktiia G1 BP monitor for 6 months

Interventions

Traditional BP monitor for 6 months / Aktiia G1 BP monitor for 6 monthsDEVICE

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.

Group 2: Traditional BP monitor (upper arm cuff) - active control
Aktiia G1 BP monitor for 12 monthsDEVICE

These participants will receive an Aktiia G1 BP monitor and wear it through the entire 12-month study period.

Group 1: Aktiia G1 BP monitor (or "Hilo") - intervention

Eligibility Criteria

Age21 Years - 85 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify 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.
  • 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.

You may not qualify 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).
  • 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.
  • +6 more criteria

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mass General Brigham Hospital

Boston, Massachusetts, 02115, United States

RECRUITING

MeSH Terms

Conditions

HypertensionVascular DiseasesCardiovascular Diseases

Central Study Contacts

Kristen Harriott

CONTACT

617-525-8493BWHWearableBP@mgb.org

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
PARALLEL
Model Details: prospective open-label 2-arm study
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 30, 2026

First Posted

April 13, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

September 1, 2027

Study Completion (Estimated)

December 1, 2027

Last Updated

April 13, 2026

Record last verified: 2026-04

Locations

US(1)