NCT06670677 Evaluation of the Clinical Benefit of the Aktiia Blood Pressure Monitoring for Early Awareness of Hypertension and Prediction of Cardiovascular Risk
| NCT ID | NCT06670677 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Aktiia SA |
| Condition | Hypertension |
| Study Type | OBSERVATIONAL |
| Enrollment | 15,000 participants |
| Start Date | 2025-05-12 |
| Primary Completion | 2035-05-31 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 15,000 participants in total. It began in 2025-05-12 with a primary completion date of 2035-05-31.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
Inclusion Criteria: 1. Adult subjects aged 21 to 85 years old 2. Subjects living in Switzerland, Germany or in the UK 3. 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) 4. Subjects agreeing to follow the study procedures. Exclusion Criteria: 1. 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; 2. 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; 3. Subjects suffering from polyneuropathy; 4. on pregnant women; 5. Subjects with damaged / injured skin at the wrists (for bracelet measurements) or at index fingers (for camera measurements) 6. Subjects with amputated index fingers (for camera measurements) or amputated upper limb; 7. Subjects below 21 years old and above 85 years old.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06670677 clinical trial?
This trial is open to participants of all sexes, aged 21 Years or older, up to 85 Years, studying Hypertension. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06670677 currently recruiting?
Yes, NCT06670677 is actively recruiting participants. Contact the research team at pascale.vermare@aktiia.com for enrollment information.
Where is the NCT06670677 trial being conducted?
This trial is being conducted at Lausanne, Switzerland, London, United Kingdom.
Who is sponsoring the NCT06670677 clinical trial?
NCT06670677 is sponsored by Aktiia SA. The trial plans to enroll 15,000 participants.