Evaluation of the Clinical Benefit of the Aktiia Blood Pressure Monitoring for Early Awareness of Hypertension and Prediction of Cardiovascular Risk
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
Aktiia SA
15,000 participants
May 12, 2025
OBSERVATIONAL
Conditions
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.
Eligibility
Inclusion Criteria5
- 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.
Exclusion Criteria7
- 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.
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.
Locations(2)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06670677