RecruitingOBSERVATIONAL

Evaluation of the Clinical Benefit of the Aktiia Blood Pressure Monitoring for Early Awareness of Hypertension and Prediction of Cardiovascular Risk

This research project, called the 'Aktiia Blood Pressure Monitoring' study, is looking into how a special wearable device can help people with high blood pressure, also known as hypertension. The main goal is to understand if continuously tracking blood pressure with the Aktiia G1 device, alongside information about a person's lifestyle and health, can lead to better ways of managing high blood pressure and foreseeing potential heart problems. Researchers hope to see how these factors are connected over time. This is a long-term study, lasting 10 years, and involves people in the UK, Switzerland, and Germany, using both Android and Apple smartphones.

At a glance

Status

Recruiting

Sponsor

Aktiia SA

Enrolment target

15,000

Start

12 May 2025

Estimated completion

31 May 2035

Hypertension Cardiovascular Risk Blood Pressure Check (Hypertension Screening)

What is this study about?

This study is designed to understand how a new kind of blood pressure monitor, the Aktiia G1, can be used to help manage your blood pressure better and give an early warning about potential heart health issues. High blood pressure, or hypertension, often doesn't have obvious symptoms, but it can significantly increase your risk of heart attacks and strokes. That's why keeping track of it is so important.

The Aktiia G1 device is unique because it's the first wrist-worn monitor that continuously checks your blood pressure. The researchers want to see if having this constant information, combined with details about your daily life and health habits, can give us a clearer picture of how blood pressure changes and what affects it. This could lead to more personalised and effective ways to keep your blood pressure healthy.

Over the next 10 years, the study will collect a lot of information from people who already use the Aktiia G1, as well as some who don't yet. By looking at all this data together, the scientists hope to develop better tools and strategies for preventing and managing high blood pressure, ultimately improving heart health for many people.

Key takeaways

Study aims to improve high blood pressure management and predict heart risks.
Uses a special wrist-worn device (Aktiia G1) for continuous blood pressure monitoring.
Involves answering surveys about lifestyle and health every six months.
Participation lasts for 10 years.
Open to adults aged 21-85 in the UK, Switzerland, or Germany with a smartphone.
Not suitable for individuals with certain heart conditions or other specific health issues.

Who may be eligible?

To join this study, you need to be an adult between 21 and 85 years old and live in the UK, Switzerland, or Germany. You also need to have a smartphone, either an Apple iPhone or an Android phone. Depending on which part of the study you join, you might already be using the Aktiia G1 device, or you might not be.

There are certain conditions that would prevent you from taking part. For example, if you have very irregular heart rhythms like atrial fibrillation, or certain health issues that affect your blood flow like Raynaud's disease or severe kidney problems. You also can't participate if you have nerve damage (polyneuropathy), if you are pregnant, or if you have any skin damage on your wrists or index fingers where measurements would be taken.

Basically, if you're a healthy adult within the age range, living in one of the specified countries with a smartphone, and don't have any of the listed medical conditions that could interfere with the blood pressure measurements, you might be suitable.

Quick self-check

Are you between 21 and 85 years old?
Do you live in the UK, Switzerland, or Germany?
Do you own a smartphone (Apple iPhone or Android)?
Are you able to complete online surveys every six months?
Do you have any serious heart rhythm problems or conditions affecting blood flow (e.g., Raynaud's disease, severe kidney issues)? (If yes, you might not be eligible)
Are you pregnant? (If yes, you are not eligible)

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you join this study, you'll be asked to take part for a long time – 10 years. If you already own an Aktiia G1 device, you'll continue to wear it regularly, just as you normally would. Every six months throughout the study, you'll need to complete a short online survey (it should take no more than 5 minutes) about your lifestyle, health, and social background.

Additionally, once a new app called 'Aktiia One App' is available, you'll be asked to take extra blood pressure checks using a new feature on the app (Aktiia G2C) that measures your blood pressure from your finger while you're sitting down. This will also continue for the entire 10-year study period. For participants who don't already own an Aktiia G1 device, the exact tasks will be slightly different, but will still involve providing survey information and potentially using the new measurement app.

Potential risks and benefits

Participating in this study might offer you the benefit of better understanding your own blood pressure patterns over a long period, which could help you and your doctor manage your health. The risks are generally low, as you'd mostly be using a device you might already own and completing surveys; there are no new medications or invasive procedures. The study involves collecting personal health and lifestyle data, which will be handled with strict privacy. You are always free to leave the study at any time, for any reason, without it affecting your medical care.

Locations (2)

Fully remote study- no physical investigational site
Lausanne, Switzerland· Recruiting
Fully remote study- no physical investigational site
London, United Kingdom· Recruiting

Common questions

What is hypertension?

Hypertension is the medical term for high blood pressure. It often has no obvious symptoms but can lead to serious health problems if not managed.

What is the Aktiia G1 device?

The Aktiia G1 is a wearable device that continuously monitors your blood pressure from your wrist.

How long will I need to be part of the study?

The study will last for 10 years, with regular surveys and continued use of the Aktiia G1 or the new app as requested.

Do I need to live in the UK to join?

Yes, you need to live in the UK, Switzerland, or Germany to be eligible for this study.

Will I get medical advice from the study?

The study collects information for research purposes and will not provide individual medical advice or recommendations.

How to find out more

Pascale Vermare

pascale.vermare@aktiia.com +41 32 552 20 52 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.