Monitoring blood pressure continuously to improve hypertension management

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

Why it matters

Who can join: the full rules

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 it's running

• 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

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.