HypertensionFORESEE2024NCT06670677
Evaluation of the Clinical Benefit of the Aktiia Blood Pressure Monitoring for Early Awareness of Hypertension and Prediction of Cardiovascular Risk
An observational study of Hypertension and Cardiovascular Risk, run by Aktiia SA at 2 sites in 2 countries.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 21 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Hypertension, Cardiovascular Risk, Blood Pressure Check (Hypertension Screening)
- What is being tested?
- Lifestyle survey completion, Unlimited on-demand blood pressure measurements with G2C and Continual blood pressure measurements with G1
- How many people
- 15,000 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 12 May 2025to 31 May 2035
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Any subjects that respect the study inclusion criteria.
Who may be able to join
- 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 join
- 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 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;
- Subjects below 21 years old and above 85 years old.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
Switzerland1 site, 1 recruiting
- Recruiting
Fully remote study- no physical investigational site
Lausanne
Pr Wuerzner, MD, +41 21 314 02 23, gregoire.wuerzner@chuv.ch
United Kingdom1 site, 1 recruiting
- Recruiting
Fully remote study- no physical investigational site
London
Dr. Manish SAXENA, MD, 0207 882 3856, m.saxena@qmul.ac.uk
About this study
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
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.
Read the detailed description
ARM 1:
N1~ 3'300 subjects.
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. ARM 1 research participants are asked to:
- For the next 10 years: wear their 24/7 Aktiia G1 device continuously as they would outside the context of the research project,
- For the next 10 years, starting at their inclusion in the research project and every 6 months thereafter: fill in an online survey on their lifestyle- health- socioeconomic environment.
- Additionally, once the Aktiia One App is released and for the next 10 years:
- Take an on-demand measurement with the Aktiia G2C feature (finger measurement) while seated.
ARM 2:
N2~ 6'600 subjects.
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. ARM 2 research participants are asked to:
- For the next 10 years: wear their 24/7 Aktiia G1 device continuously as they would outside the context of the research project,
- For the next 10 years, starting at their inclusion in the research project and every 6 months thereafter: fill in an online survey on their lifestyle- health- socioeconomic environment. The completion of a survey lasts 5min maximum.
- Additionally, once the Aktiia One App is released and for the next 10 years:
- Take an on-demand measurement with the Aktiia G2C feature (finger measurement) while seated.
ARM 3:
N3~ 5'000 subjects.
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. ARM 3 research participants are asked to:
- For the next 10 years, starting at their inclusion in the research project and every 6 months thereafter: fill in an online survey on their lifestyle- health- socioeconomic environment. The completion of a survey lasts 5min maximum.
- At their inclusion in the study: download the Aktiia One App to access G2C functionality with on-demand measurements at fingertip using the smartphone's camera.
- For the next 10 years, starting at their inclusion in the research project and thereafter:
- Take unlimited on-demand measurements with the Aktiia G2C feature.
- Being tested
- Lifestyle survey completion, Unlimited on-demand blood pressure measurements with G2C, Continual blood pressure measurements with G1
- Keywords
- hypertension, blood pressure, Hypertensive, cardiovascular diseases, cardiovascular risk, prediction
- Medical subject headings
- Hypertension, Cardiovascular Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Lifestyle survey completionOther
For the next 10 years, starting at their inclusion in the research project and every 6 months thereafter: fill in an online survey on their lifestyle- health- socioeconomic environment. The completion of a survey lasts 5min maximum.
Unlimited on-demand blood pressure measurements with G2COther
For the next 10 years: take unlimited on-demand measurements with the Aktiia G2C feature (finger measurement) while seated
Continual blood pressure measurements with G1Other
For the next 10 years: wear their 24/7 Aktiia G1 device continuously as they would outside the context of the research project.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Lifestyle survey completion; Other: Unlimited on-demand blood pressure measurements with G2C; Other: 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. Receives: Other: Lifestyle survey completion; Other: Unlimited on-demand blood pressure measurements with G2C; Other: 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. Receives: Other: Lifestyle survey completion; Other: Unlimited on-demand blood pressure measurements with G2C |
What is being measured
The primary outcome is the main question the study is designed to answer.
Multivariate models relating data from 24/7 Aktiia the G1 device continual BP monitoring with sociodemographic - lifestyle - and health factors
Strength and direction of the correlation coefficient between continuous blood pressure readings and various survey-derived factors such as sociodemographic variables, lifestyle habits, and health metrics.
Measured: 10 years
Secondary outcomes (1)
Global scale projections of the benefit of the early awareness of hypertension with the spot-check Aktiia G2C device at the fingertip
Proportion of subjects with early hypertension awareness enabled by the fingertip spot-check feature of the Aktiia G2C device.
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Nov 2024
- Study start12 May 2025
- Primary completion31 May 2035 (estimated)
- Study completion31 May 2035 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HypertensionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Aktiia SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06670677
- Sponsor's protocol ID
- OBPM_FORESEE2024
- Other IDs
- SNCTP
- Acronym
- FORESEE2024
- Status last verified
- May 2025
- First submitted
- 23 Oct 2024
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT06670677
- Acronym / sponsor ID
- FORESEE2024 / OBPM_FORESEE2024
- Keywords
- hypertension, blood pressure, Hypertensive, cardiovascular diseases, cardiovascular risk, prediction
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 15,000 participants (estimated)
- Lead sponsor
- Aktiia SAIndustry (pharma, biotech, devices)
- Study start
- 12 May 2025 (actual)
- Primary completion
- 31 May 2035 (estimated)
- Study completion
- 31 May 2035 (estimated)
- First posted
- 1 Nov 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
ARM 1:
N1~ 3'300 subjects.
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. ARM 1 research participants are asked to:
- For the next 10 years: wear their 24/7 Aktiia G1 device continuously as they would outside the context of the research project,
- For the next 10 years, starting at their inclusion in the research project and every 6 months thereafter: fill in an online survey on their lifestyle- health- socioeconomic environment.
- Additionally, once the Aktiia One App is released and for the next 10 years:
- Take an on-demand measurement with the Aktiia G2C feature (finger measurement) while seated.
ARM 2:
N2~ 6'600 subjects.
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. ARM 2 research participants are asked to:
- For the next 10 years: wear their 24/7 Aktiia G1 device continuously as they would outside the context of the research project,
- For the next 10 years, starting at their inclusion in the research project and every 6 months thereafter: fill in an online survey on their lifestyle- health- socioeconomic environment. The completion of a survey lasts 5min maximum.
- Additionally, once the Aktiia One App is released and for the next 10 years:
- Take an on-demand measurement with the Aktiia G2C feature (finger measurement) while seated.
ARM 3:
N3~ 5'000 subjects.
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. ARM 3 research participants are asked to:
- For the next 10 years, starting at their inclusion in the research project and every 6 months thereafter: fill in an online survey on their lifestyle- health- socioeconomic environment. The completion of a survey lasts 5min maximum.
- At their inclusion in the study: download the Aktiia One App to access G2C functionality with on-demand measurements at fingertip using the smartphone's camera.
- For the next 10 years, starting at their inclusion in the research project and thereafter:
- Take unlimited on-demand measurements with the Aktiia G2C feature.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| ARM 1 G1 Aktiia users Android | – | Other: Lifestyle survey completion, Other: Unlimited on-demand blood pressure measurements with G2C, Other: Continual blood pressure measurements with G1Research 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. |
| ARM 2 G1 AKTIIA users iOS | – | Other: Lifestyle survey completion, Other: Unlimited on-demand blood pressure measurements with G2C, Other: Continual blood pressure measurements with G1Research 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. |
| ARM 3 non-Aktiia-G1-users Android & iOS | – | Other: Lifestyle survey completion, Other: Unlimited on-demand blood pressure measurements with G2CResearch 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. |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Any subjects that respect the study inclusion criteria.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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 suffering from polyneuropathy;
- on pregnant women;
- Subjects with damaged / injured skin at the wrists (for bracelet measurements) or at index fingers (for camera measurements)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Lifestyle survey completionFor the next 10 years, starting at their inclusion in the research project and every 6 months thereafter: fill in an online survey on their lifestyle- health- socioeconomic environment. The completion of a survey lasts 5min maximum. | Other | ARM 1 G1 Aktiia users Android, ARM 2 G1 AKTIIA users iOS, ARM 3 non-Aktiia-G1-users Android & iOS |
| Unlimited on-demand blood pressure measurements with G2CFor the next 10 years: take unlimited on-demand measurements with the Aktiia G2C feature (finger measurement) while seated | Other | ARM 1 G1 Aktiia users Android, ARM 2 G1 AKTIIA users iOS, ARM 3 non-Aktiia-G1-users Android & iOS |
| Continual blood pressure measurements with G1For the next 10 years: wear their 24/7 Aktiia G1 device continuously as they would outside the context of the research project. | Other | ARM 1 G1 Aktiia users Android, ARM 2 G1 AKTIIA users iOS |
Primary outcome
Multivariate models relating data from 24/7 Aktiia the G1 device continual BP monitoring with sociodemographic - lifestyle - and health factors
Time frame: 10 years
Strength and direction of the correlation coefficient between continuous blood pressure readings and various survey-derived factors such as sociodemographic variables, lifestyle habits, and health metrics.
1 secondary outcome
Global scale projections of the benefit of the early awareness of hypertension with the spot-check Aktiia G2C device at the fingertip
Time frame: 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hypertension and Cardiovascular Risk, run by Aktiia SA at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland, United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Pascale Vermare (+41 32 552 20 52, pascale.vermare@aktiia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Multivariate models relating data from 24/7 Aktiia the G1 device continual BP monitoring with sociodemographic - lifestyle - and health factors (time frame: 10 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.