Monitoring blood pressure continuously to improve hypertension management
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
This study is testing whether using a continuous blood pressure monitoring device can help people with high blood pressure manage their condition better over ten years.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 15000 (estimated) |
| Ages | 21 Years to 85 Years |
| Sex | All |
| Sponsor | Aktiia SA Industry-sponsored |
| Locations | 2 sites (Lausanne and 1 other locations) |
| Trial ID | NCT06670677 on ClinicalTrials.gov |
What this trial studies
This study evaluates the clinical benefits of the Aktiia blood pressure monitoring device, focusing on its ability to provide continuous blood pressure readings and correlate these with various health and environmental factors. Participants, who are existing users of the Aktiia G1 device, will wear the device continuously for 10 years and complete online surveys every six months about their lifestyle and health. The study aims to gather extensive data to enhance hypertension management and predict cardiovascular risks based on continuous monitoring. The research includes two arms based on the smartphone operating system used by participants.
Who should consider this trial
Good fit: Ideal candidates are adults aged 21 to 85 who are existing users of the Aktiia G1 device and reside in Switzerland, Germany, or the UK.
Not a fit: Patients with certain cardiac arrhythmias, severe peripheral perfusion issues, or other specified health conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to improved management of hypertension and reduced cardiovascular risk for patients.
How similar studies have performed: While this approach is innovative in its use of continuous monitoring technology, similar studies have shown promise in managing hypertension through regular monitoring.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Lausanne and 1 other locations
- Fully remote study- no physical investigational site — Lausanne, Switzerland (Recruiting)
- Fully remote study- no physical investigational site — London, United Kingdom (Recruiting)
Study contacts
- Study coordinator: Pascale Vermare
- Email: pascale.vermare@aktiia.com
- Phone: +41 32 552 20 52
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.