NCT06670677Recruiting
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
Source: ClinicalTrials.gov · Last updated 14 May 2025 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 15000 (estimated)
- First submitted
- 23 Oct 2024
- Start date
- 12 May 2025
- Primary completion date
- 31 May 2035
- Lead sponsor
- Aktiia SA
- Diseases
- High blood pressure
- NCT number
- NCT06670677
What you commit to
- Study type: Observational
- Planned participants: 15000
- From 12 May 2025 to the primary completion date, 31 May 2035
- 2 sites in 2 countries
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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;
Lab values
- 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;
Age
- Subjects below 21 years old and above 85 years old.
Other
- 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;
Who the study is looking for
- 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.
Age in the registry: 21 years to 85 years · Sex: All · Accepts healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| - Coordinator of this site? Confirm its status | Lausanne | Switzerland | Recruiting |
| - Coordinator of this site? Confirm its status | London | United Kingdom | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.