WEARABLE-BP: Wearable Everyday Automated Readings to Enable Assessment of Blood Pressure Control
ConditionHypertension (HTN)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age21-85
SponsorAktiia SA
About this trial
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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Severe hypertension (SBP > 180 mmHg or DBP > 120 mmHg).
Pregnant or breastfeeding.
Known severe heart failure (LVEF < 35%).
Known severe valvular heart disease.
Trial design
Treatments tested in this trial
- Aktiia G1 BP monitor for 12 months
- Traditional BP monitor for 6 months / Aktiia G1 BP monitor for 6 months
Treatment groups
164 Participants
are divided into 2 treatment groupsLocations
1Mass General Brigham Hospital02115, BostonMassachusetts, United States
Sponsors and collaborators
Aktiia SA
Lead sponsor
Massachusetts General Hospital
Collaborator
Brigham and Women's Hospital
Collaborator
Source ClinicalTrials.gov