Tracks blood pressure with a wearable device to study heart risk
Studies blood pressure monitoring with a wearable device in adults to find early hypertension.
Key facts
- Who runs it
- Aktiia SA
- Where
- Lausanne, SwitzerlandSee the siteAlso in 1 other country, 1 site
- Trial code
- Registry title
- Evaluation of the Clinical Benefit of the Aktiia Blood Pressure Monitoring for Early Awareness of Hypertension and Prediction of Cardiovascular Risk
- Status
- Recruiting
- People taking part
- 15,000 people, planned
- Started
- 12 May 2025
- Expected to end
- 31 May 2035
- Type of study
- Observational, 3 groups
- Treatments tested
- Lifestyle survey completion
- Unlimited on-demand blood pressure measurements with G2C
- Continual blood pressure measurements with G1
- Record updated
- 14 May 2025
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for adults aged 21 to 85 who live in Switzerland, Germany or the UK and own a smartphone. Some already use the Aktiia blood pressure monitor, some do not.
- Age
- 21 to 85 years
- Sex
- All sexes can join.
Main reasons for not taking part
- Long-lasting heart rhythm problems such as a resting heart rate above 120bpm or atrial fibrillation
- Illnesses that reduce blood flow in the limbs, such as Raynaud's disease, diabetes, kidney problems (eGFR < 30mL / min / 1.73 m2), untreated thyroid disease, pheochromocytoma or arteriovenous fistula
- Polyneuropathy
- Pregnant women
- Damaged skin at the wrists or index fingers, or amputated index fingers or upper limb
The registry criteria, word for word
Show all 11 criteriaShow less
Who can take part
- Adult subjects aged 21 to 85 years old
- Subjects living in Switzerland, Germany or in the UK
- Subjects that are:; Aktiia users owning a smartphone with either iOS or Android operating system (ARMs 1 and 2); or Aktiia non-users owning a smartphone with iOS or Android operating system (ARM 3)
- Subjects agreeing to follow the study procedures
Who cannot take part
- Subjects suffering from sustained cardiac arrhythmias that can lead to weak or unstable pressure pulses including resting tachycardia (heart rate at rest > 120bpm) and atrial fibrillation
- Subjects suffering from pathologies that systematically reduce peripheral perfusion including Raynaud's disease, diabetes, renal dysfunctions (eGFR < 30mL / min / 1.73 m2), untreated hyper-/ hypothyroidism, pheochromocytoma, or arteriovenous fistula
- Subjects below 21 years old and above 85 years old
- Subjects suffering from polyneuropathy
- on pregnant women
- Subjects with damaged / injured skin at the wrists (for bracelet measurements) or at index fingers (for camera measurements)
- Subjects with amputated index fingers (for camera measurements) or amputated upper limb
Check if you might fit
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 21 and 85 years old?
Where in Switzerland
Also in 1 other country, 1 site
- LausanneHospital not named in the registryContact: Pr Wuerzner, MDTaking people
About the trial
What the trial wants to find out
Because Aktiia S.A. has been the first-ever company to put in the market an Optical Blood Pressure Monitoring device, there is a need for Aktiia S.A. to correlate for the first time continual Blood Pressure monitoring and the evolution of environmental and health factors to improve hypertension management.
The 3 groups in the trial
- ARM 1 G1 Aktiia users Android
Research participants are Aktiia G1 users with Android operating system, i.e. individuals who already purchased the Aktiia G1 device out of the context of the study, located in Switzerland, Germany or UK, and owning a smartphone with Android operating system.
Treatment: Lifestyle survey completion, Unlimited on-demand blood pressure measurements with G2C, and Continual blood pressure measurements with G1
- ARM 2 G1 AKTIIA users iOS
Research participants are Aktiia G1 users with iOS operating system, i.e. individuals who already purchased the Aktiia G1 device out of the context of the study, located in Switzerland, Germany or UK, and owning a smartphone with iOS operating system.
Treatment: Lifestyle survey completion, Unlimited on-demand blood pressure measurements with G2C, and Continual blood pressure measurements with G1
- ARM 3 non-Aktiia-G1-users Android & iOS
Research participants are non-Aktiia-G1 users (they do not own an Aktiia G1 device at their inclusion in the study), located in Switzerland, Germany or UK, and owning a smartphone with either iOS or Android operating system.
Treatment: Lifestyle survey completion and Unlimited on-demand blood pressure measurements with G2C
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- OBPM_FORESEE2024: 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: an Observational Cohorts' Study
- Plain-language title
- Tracks blood pressure with a wearable device to study heart riskGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Fit questions
- Built from NCT06670677, who can take part
- Record updated
- 14 May 2025