Actively Recruiting
Evaluation of the Clinical Benefit of the Aktiia Blood Pressure Monitoring for Early Awareness of Hypertension and Prediction of Cardiovascular Risk in a Multi-ethnic European Population
Led by Aktiia SA · Updated on 2025-05-14
15000
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
This research evaluates the clinical benefits of the Aktiia Blood Pressure Monitoring system for early detection of hypertension and predicting cardiovascular risk. The study involves a multi-ethnic European population and aims to correlate continuous blood pressure monitoring with environmental and health factors over time to improve hypertension management. It is an observational study sponsored by Aktiia SA. Participants are divided into three groups: those who already own the Aktiia G1 device with Android smartphones, those with iOS smartphones, and individuals without the Aktiia G1 device but owning either iOS or Android smartphones. Over the next 10 years, participants who own the Aktiia G1 device will wear it continuously. All participants will complete online surveys about their lifestyle, health, and socioeconomic environment every six months. Additionally, once available, participants will use the Aktiia One App to take on-demand fingertip blood pressure measurements using the smartphone camera. During the study, participants will be monitored through continuous blood pressure data from the Aktiia G1 device and periodic surveys. The main outcome measured is how continuous blood pressure monitoring relates to sociodemographic, lifestyle, and health factors over 10 years. Secondary outcomes include projections of benefits from early hypertension awareness using the fingertip measurement feature. Participants engage in regular surveys and on-demand blood pressure checks, with the study lasting up to 10 years.
CONDITIONS
Brief Title
Evaluation of the Clinical Benefit of the Aktiia Blood Pressure Monitoring for Early Awareness of Hypertension and Prediction of Cardiovascular Risk
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Adult subjects aged 21 to 85 years old
- Living in Switzerland, Germany, or the UK
- Aktiia users owning a smartphone with iOS or Android (ARMs 1 and 2) or non-Aktiia users owning a smartphone with iOS or Android (ARM 3)
- Agreeing to follow the study procedures
You will not qualify if you...
- Having sustained cardiac arrhythmias that cause weak or unstable blood pressure pulses, including resting heart rate over 120 bpm or atrial fibrillation
- Having conditions that reduce peripheral blood flow such as Raynaud's disease, diabetes, kidney dysfunction (eGFR less than 30 mL/min/1.73 m2), untreated thyroid disorders, pheochromocytoma, or arteriovenous fistula
- Having polyneuropathy
- Being pregnant
- Having damaged or injured skin at wrists (for bracelet) or index fingers (for camera measurements)
- Having amputated index fingers or upper limbs
- Being younger than 21 or older than 85 years old
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (online or remote)
Duration - 10 years
Participants are observed while wearing the Aktiia G1 device continuously as they normally would outside the study and completing lifestyle, health, and socioeconomic surveys every 6 months.
Surveys every 6 months online; continuous device use
Duration - Up to 10 years
Participants take unlimited on-demand blood pressure measurements using the Aktiia G2C feature (finger measurement) via the Aktiia One App once available.
On-demand measurements anytime as desired
Trial Site Locations
Total: 2 locations
1
Fully remote study- no physical investigational site
Lausanne, Switzerland
Actively Recruiting
2
Fully remote study- no physical investigational site
London, United Kingdom
Actively Recruiting
Research Team
P
Pascale Vermare
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
3
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