RecruitingNAINTERVENTIONAL

Baroloop Multicenter Trial (Baroloop MCT)

The Baroloop Multicenter Trial is testing a new device called the 'baroloop system' for adults in the UK who have high blood pressure that hasn't responded well to usual medications. Doctors call this 'resistant hypertension'. The main aims of the study are to find out if the baroloop device is safe to use and whether it effectively lowers blood pressure. Participants will have the device fitted and then attend regular check-ups over two years. These check-ups will involve adjusting the device settings and other tests. The study also wants to understand how the new treatment affects people's quality of life.

At a glance

Status

Recruiting

Phase

Sponsor

neuroloop GmbH

Enrolment target

120

Start

22 May 2024

Estimated completion

01 Dec 2031

Hypertension, Resistant to Conventional Therapy

What is this study about?

This important study, called the Baroloop Multicenter Trial, is for people in the UK whose high blood pressure (hypertension) is proving difficult to manage with standard medications. If your blood pressure remains high despite taking several different medicines, doctors might call it 'resistant hypertension'. The trial is looking at a new treatment option – a device called the 'baroloop system' – to see if it can help.

The main goals are to make sure the baroloop device is safe for patients and to see if it can successfully lower blood pressure. It's a big step in understanding if this new approach could offer hope to those who haven't found enough relief from current treatments. The researchers also want to hear about your experiences and how the treatment might affect your daily life and wellbeing.

Taking part would involve having the baroloop device implanted. After that, you'd have several follow-up appointments over two years. These visits are crucial for checking how you're doing, making any necessary adjustments to the device, and carrying out other health checks related to the study. Your comfort and safety are a top priority throughout the entire process.

Key takeaways

Tests a new device for hard-to-treat high blood pressure.
Aims to check device safety and its ability to lower blood pressure.
Involves device implantation and regular clinic visits over two years.
Participants continue their blood pressure medications.
Open to adults whose blood pressure is not controlled by current treatment.
You can stop participating at any time.

Who may be eligible?

This study is looking for adults aged 18 and over who have persistently high blood pressure, even after trying several medications. Specifically, your blood pressure readings, both in the doctor's office and with a 24-hour monitor, would need to be above certain levels.

You would also need to be on a stable regimen of at least three specific blood pressure medicines for at least four weeks before joining. It's important that you are willing and able to attend all the scheduled follow-up appointments and give your informed consent, meaning you understand and agree to take part.

There are also some reasons why you might not be able to join. For example, if you have certain existing health conditions like severe kidney problems, poorly controlled diabetes, or severe sleep apnea. Also, if you have had certain neck surgeries, have a pacemaker, or a history of specific heart or brain conditions recently, you might not be eligible. The size of certain nerves in your neck or a history of nerve injury in that area would also need to be checked.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Is your blood pressure still high even with several medications?
Are you able and willing to attend all follow-up appointments for two years?
Have you been on a stable regimen of at least three blood pressure medicines for 4 weeks?
Do you have a clear understanding and are you willing to sign a consent form?
Do you have any conditions like severe kidney problems, uncontrolled diabetes, or recent strokes?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will have a small medical procedure to implant the baroloop device. After the device is fitted, you will need to attend several follow-up appointments over a period of two years. These visits will be at 14 days, 3 months, 6 months, 12 months, 18 months, and 24 months after the device is implanted.

During these appointments, the study team will adjust the settings of the device as needed, and carry out various health checks and assessments related to the study. You will also be asked to answer questions about your general health and how the treatment is affecting your quality of life. You will continue to take your prescribed blood pressure medications as advised by your study doctor throughout the trial. The total duration of your active participation in the study will be two years.

Potential risks and benefits

Participating in a clinical trial has potential benefits and risks. The potential benefit of this study is that the baroloop device might help to lower your blood pressure when other medicines haven't been enough, which could improve your long-term health. However, as with any medical procedure, there are potential risks, including those related to the device implantation and the device itself, such as infection or side effects related to its stimulation. These will be fully explained by the study team. You always have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (4)

Clemenshospital Münster
Verified postcode
Münster, Germany· Recruiting
Marienhaus Klinikum Mainz
Verified postcode
Mainz, Germany· Recruiting
Städtisches Klinikum Dresden
Verified postcode
Dresden, Germany· Recruiting
UMC Utrecht
Verified postcode
Utrecht, Netherlands· Recruiting

Common questions

What is 'resistant hypertension'?

It's when your high blood pressure remains high despite taking several different types of blood pressure medications.

What is the 'baroloop system'?

It's a new medical device being tested to see if it can help lower blood pressure in people who haven't responded well to medicines.

How long does the study last?

If you take part, you will be followed for a period of two years after the device is implanted.

Will I still take my usual blood pressure medicines?

Yes, you will continue to take your prescribed blood pressure medications as advised by the study doctor during the trial.

Can I leave the study if I change my mind?

Yes, you can withdraw from the study at any time, for any reason, without it affecting your medical care.

How to find out more

Medical Scientific Affairs

study@neuroloop.de +49 761 1543390 Official trial record

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