Evaluation of the Clinical Benefit of the Aktiia Blood Pressure Monitoring for Early Awareness of Hypertension and Prediction of Cardiovascular Risk
FORESEE2024
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
2 other identifiers
observational
15,000
2 countries
2
Brief 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started May 2025
Longer than P75 for all trials
2 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 23, 2024
CompletedFirst Posted
Study publicly available on registry
November 1, 2024
CompletedStudy Start
First participant enrolled
May 12, 2025
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2035
ExpectedStudy Completion
Last participant's last visit for all outcomes
May 31, 2035
May 14, 2025
May 1, 2025
10.1 years
October 23, 2024
May 12, 2025
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
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
10 years
Study Arms (3)
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.
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.
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.
Interventions
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.
For the next 10 years: take unlimited on-demand measurements with the Aktiia G2C feature (finger measurement) while seated
For the next 10 years: wear their 24/7 Aktiia G1 device continuously as they would outside the context of the research project.
Eligibility Criteria
Any subjects that respect the study inclusion criteria.
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Aktiia SAlead
Study Sites (2)
Fully remote study- no physical investigational site
Lausanne, Switzerland
Fully remote study- no physical investigational site
London, United Kingdom
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
October 23, 2024
First Posted
November 1, 2024
Study Start
May 12, 2025
Primary Completion (Estimated)
May 31, 2035
Study Completion (Estimated)
May 31, 2035
Last Updated
May 14, 2025
Record last verified: 2025-05
Data Sharing
- IPD Sharing
- Will not share