A Pivotal, Multicenter, Blinded, Sham Procedure-Controlled Trial of Renal Denervation by the Peregrine System™ Kit, in Subjects with Hypertension
High blood pressure is very common and can lead to serious health problems like heart attacks and strokes. While tablets help many people, some still struggle to keep their blood pressure under control. This study tests a medical device called the Peregrine System Kit. The system uses a small tube (catheter) to calm overactive nerves around the blood vessels leading to the kidneys, a process called renal denervation. In this study, some participants will receive the real procedure, while others will have a 'sham' (dummy) procedure to see if the device genuinely works. Researchers will follow participants for up to a year. They will check blood pressure at clinic visits and using 24-hour monitors worn at home. The goal is to see if the procedure lowers blood pressure and helps reduce the need for tablets.
At a glance
What is this study about?
Blood pressure is the force of your blood pushing against the walls of your blood vessels. When it stays too high for a long time, it can damage your blood vessels and strain your heart. For many people, everyday tablets and lifestyle changes work well. However, for others, blood pressure remains stubbornly high. Doctors are looking for new, long-term ways to help.
The nerves surrounding the kidneys play a major role in controlling blood pressure. In people with high blood pressure, these nerves can become overactive and send signals that make blood vessels tighten. This study is testing an experimental treatment called renal denervation using the Peregrine System Kit. The treatment delivers a small amount of medication through a thin tube directly to the nerves outside the kidney arteries to calm them down.
To be certain that the treatment really works and is safe, this study uses a 'sham-controlled' design. This means half the patients receive the actual nerve treatment, and the other half receive a dummy procedure where no nerve treatment is given. Neither you nor the doctors checking your blood pressure will know which group you are in during the initial testing period. This helps make the study results as fair and reliable as possible.
Key takeaways
- The study tests a new keyhole procedure to lower high blood pressure by calming nerves near the kidneys.
- Half of the participants will receive the real procedure, and half will receive a dummy (sham) procedure.
- You will be asked to wear a 24-hour blood pressure monitor at home at several points during the trial.
- Participation lasts for around 6 to 12 months with regular check-up visits.
- Joining the study is completely your choice, and you can withdraw at any time.
Who may be eligible?
This trial is open to adults aged 18 and older who have persistent high blood pressure. Both men and women can take part.
To qualify, your blood pressure will need to remain above recommended targets despite medical care. The research team will review your health history, your current medications, and the health of your kidneys and blood vessels to see if the procedure is suitable for you.
People with certain other health conditions, such as severe kidney disease or specific problems with their blood vessels, may not be able to join. The study team will carry out detailed health checks before you can take part.
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.
- I am aged 18 or older.
- I have been diagnosed with high blood pressure.
- My blood pressure stays high despite taking prescribed tablets.
- I am willing to undergo a minor hospital procedure.
- I am able to attend follow-up clinic visits and wear a 24-hour blood pressure cuff.
What does participation involve?
Taking part involves several clinic visits over 6 to 12 months. Before the procedure, you will attend screening visits to check your general health, have blood tests, and wear a 24-hour blood pressure monitor at home. You will then have the keyhole procedure in hospital, which is done through a small puncture in a blood vessel, usually in the groin. After the procedure, you will attend regular follow-up visits at 4 weeks, 3 months, 6 months, and 12 months. At these appointments, the team will check your blood pressure, monitor your medications, and ask you to wear the 24-hour monitor again. Your doctor may adjust your blood pressure tablets during the study according to set safety guidelines.
Potential risks and benefits
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Common questions
What is renal denervation?
It is a keyhole procedure that treats the nerves running along the arteries to your kidneys. Calming these nerves can help your blood vessels relax and lower your blood pressure.
What is a sham procedure?
A sham procedure is a dummy procedure. You receive sedation and a check of your blood vessels, but the nerve treatment itself is not done. This helps researchers prove whether the actual device makes a real difference.
Will I still need to take my blood pressure tablets?
Yes. You will still need your regular medications unless the study doctors safely adjust your prescription based on your blood pressure readings.
How is my blood pressure measured during the study?
It is measured during clinic visits and also using a 24-hour monitor that you wear at home, which takes readings automatically throughout the day and night.
Does taking part cost anything?
No. The study treatment, tests, and care are provided free of charge, and trial teams often help cover reasonable travel expenses to visits.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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