A Study of the ReCor Medical Paradise System in Clinical Hypertension
This study, called RADIANCE-HTN, is investigating a new treatment for high blood pressure using the Paradise® Renal Denervation Ultrasound System. This system uses ultrasound energy to treat nerves near the kidneys that are involved in controlling blood pressure. The study is split into two groups: one for people who have high blood pressure that's usually controlled with one or two medications (SOLO cohort), and another for those with high blood pressure that's hard to control even with several medications (TRIO cohort). To make sure the results are reliable, some participants will receive the real treatment, while others will have a 'sham procedure' – a pretend treatment without the ultrasound – so nobody knows who got what until the end. The main goal is to find out if this new system is safe and effective in lowering blood pressure.
At a glance
What is this study about?
You might be reading this because you have high blood pressure, and you're interested in learning about new ways to manage it. This study is testing a new treatment called the Paradise® Renal Denervation System. High blood pressure, also known as hypertension, means the blood flowing through your arteries is pushing too hard against their walls. Over time, this can lead to serious health problems like heart attacks, strokes, and kidney disease. Current treatments usually involve lifestyle changes and medicines, but for some people, these aren't enough.
This new Paradise system aims to lower blood pressure by using gentle ultrasound waves to calm down certain nerves near your kidneys. These nerves play a role in regulating blood pressure. By treating them, doctors hope to reduce your blood pressure.
The study is set up very carefully to get clear answers. It involves two main groups of people. One group (called SOLO) includes people whose high blood pressure is usually managed with one or two medicines, or who have high blood pressure without taking any medicine. The other group (called TRIO) consists of people whose high blood pressure is more difficult to control, even when they're taking at least three different blood pressure medicines. By studying these different groups, researchers hope to understand who might benefit most from this new treatment and whether it's a safe and effective option.
Key takeaways
- This study is testing a new ultrasound treatment for high blood pressure.
- It aims to find out if the Paradise® system is safe and effective for people with different types of high blood pressure.
- Participants will either get the active treatment or a pretend (sham) procedure, without knowing which one.
- Close medical checks and monitoring will be provided throughout the study.
- You can withdraw from the study at any point without affecting your medical care.
Who may be eligible?
To join this study, you would generally need to be between 18 and 75 years old and have a clear medical history of high blood pressure. Your doctors would review your health carefully to make sure the study is right for you. They'll also check your kidney health using scans to make sure the treatment can be safely performed.
There are some key differences depending on which group you might fit into. If you're in the SOLO group, you might be taking one or two blood pressure medicines, or sometimes no medicines at all, but your blood pressure is still high enough to be a concern. If you're in the TRIO group, you'd be taking at least three different blood pressure medications, including a water tablet (diuretic), but your blood pressure is still quite high.
However, this treatment isn't suitable for everyone. For example, if your kidney arteries are unusually narrow or wide, or if you have certain existing kidney conditions or a single functioning kidney, you wouldn't be able to take part. People with active infections or uncontrolled diabetes would also not be able to join. Your study doctor would discuss all of these points in detail with you.
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 between 18 and 75 years old?
- Do you have a diagnosis of high blood pressure?
- Are you able to attend appointments and follow study instructions?
- Do you have any severe kidney problems or uncontrolled diabetes?
- Are you taking specific blood pressure medications, or none at all, that match the study descriptions?
What does participation involve?
If you decide to join this study, it would involve several visits to the clinic. First, there would be screening appointments where doctors would check your medical history, measure your blood pressure, and do some scans to make sure the treatment is safe for you. If you qualify, you would then be randomly assigned to either receive the Paradise® ultrasound treatment or a 'sham' (pretend) procedure. This means neither you nor your study doctors would know which one you received until much later, which helps ensure the study results are fair and accurate.
The procedure itself involves placing a small device into the artery that leads to your kidney, usually through a small cut in your leg. If you're receiving the active treatment, this device would deliver ultrasound energy to the nerves. If you're getting the sham procedure, the doctor would go through similar steps but without delivering any ultrasound. After the procedure, you'd have regular follow-up visits, blood pressure checks, and possibly other tests over a period of time to see how the treatment is affecting you and your blood pressure. You would also need to continue taking any prescribed medications as advised by the study team.
Potential risks and benefits
Locations (49)
- University of Alabama at BirminghamVerified postcodeBirmingham, United States
- Cedars-Sinai Medical CenterVerified postcodeLos Angeles, United States
- Sutter Health Medical CenterVerified postcodeSacramento, United States
- Stamford HospitalVerified postcodeStamford, United States
- The Cardiac and Vascular InstituteVerified postcodeGainesville, United States
- Emory University Hospital MidtownVerified postcodeAtlanta, United States
- Southern Illinois University MedicineVerified postcodeSpringfield, United States
- Franciscan Health IndianapolisVerified postcodeIndianapolis, United States
- Ochsner Heart and Vascular InsituteVerified postcodeNew Orleans, United States
- Massachusetts General HospitalVerified postcodeBoston, United States
- The Brigham and Women's HospitalVerified postcodeBoston, United States
- Minneapolis Heart InstituteVerified postcodeMinneapolis, United States
Common questions
What is 'renal denervation'?
It's a procedure that uses energy, like ultrasound, to quiet down certain nerves near your kidneys that contribute to high blood pressure.
Will I know if I'm getting the real treatment or the pretend one?
No, during the study, neither you nor your doctors will know if you received the active treatment or a 'sham' (pretend) procedure. This helps make the study results more reliable.
How long does the study last?
The full duration of your participation, including follow-up visits, will be explained by the study team if you're eligible to join.
Do I have to stop my blood pressure medications if I join?
This depends on which study group you might be in. For some, adjustments to medication might be part of the process, but this would be closely managed by the study doctors.
What if I change my mind after joining?
You are free to leave the study at any time, for any reason, without it affecting your medical care.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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