Active not recruitingNAINTERVENTIONAL

The RADIANCE II Pivotal Study: A Study of the ReCor Medical Paradise System in Stage II Hypertension

The 'RADIANCE II Pivotal' study is looking at a new treatment called the Paradise System for people with high blood pressure (Stage 2 hypertension). This system works by treating certain nerves around the kidneys. The main goal is to find out if the Paradise System is safe and effective at lowering blood pressure in people who aren't currently taking many blood pressure medicines (0-2 types). Before joining, participants will stop their blood pressure medication for a short period. Researchers will then measure their blood pressure to make sure it's still elevated. This helps them see the true effect of the Paradise System on blood pressure without other medications getting in the way.

At a glance

Status

Active not recruiting

Phase

Sponsor

ReCor Medical, Inc.

Enrolment target

225

Start

14 Dec 2018

Estimated completion

01 Jul 2027

Hypertension Vascular Diseases Cardiovascular Diseases

What is this study about?

This study, called RADIANCE II Pivotal, is investigating a new way to treat high blood pressure using a device called the Paradise System. High blood pressure, also known as hypertension, is a common condition that can lead to serious health problems like heart attacks and strokes if not managed. This particular study is focusing on people with 'Stage 2 hypertension', which means their blood pressure is consistently quite high, but not dangerously so.

The Paradise System works by treating nerves around the kidneys. These nerves play a role in controlling blood pressure. The idea behind this treatment is that by calming these nerves, blood pressure could be lowered. For this study, researchers want to see how well and how safely this happens in people who are taking very few or no blood pressure medications at the start of the study. This setup helps them clearly see the impact of the new treatment itself.

Before anyone can join, they'll need to stop taking their blood pressure medicines for a short while, and doctors will check their blood pressure carefully to make sure it’s still high enough for the study. If it is, they might be able to take part. The study will then compare the Paradise System to other approaches to see which is more effective at lowering blood pressure.

Key takeaways

This study is for people with moderately high blood pressure.
It's testing a new device called the Paradise System that targets kidney nerves.
Participants will temporarily stop their blood pressure medication.
The goal is to see if the system safely and effectively lowers blood pressure.
Participation involves medical procedures and regular check-ups.

Who may be eligible?

To join this study, you generally need to be between 18 and 75 years old and have high blood pressure that's been confirmed by your doctor. Your blood pressure should be above certain levels when measured both at the doctor's office and with a special home monitor you wear. You also need to be taking no more than two different types of blood pressure medication, or currently taking none.

There are also some reasons you wouldn't be able to join. For example, if your kidneys aren't healthy enough, or if you have specific heart problems, a history of stroke, or certain types of diabetes. Also, if your blood vessels in the kidney area aren't suitable for the procedure, or if you've been in hospital frequently for very high blood pressure recently, you won't be able to participate. Women who are pregnant, breastfeeding, or planning to become pregnant also cannot join.

Quick self-check

Are you between 18 and 75 years old?
Do you have high blood pressure that's not well-controlled?
Are you currently taking two or fewer blood pressure medications (or none at all)?
Have you not had a recent stroke or serious heart event?
Do you not have advanced kidney disease or uncontrolled diabetes?

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

What does participation involve?

If you decide to take part in this study, you'll first be asked to stop any blood pressure medication you're currently taking for about four weeks. During this time, your blood pressure will be checked carefully, including using a portable monitor you wear at home. If your blood pressure is still high enough, and you meet all other requirements, you might then be randomly assigned to either receive the Paradise System treatment or a comparison procedure.

The Paradise System treatment involves a small procedure where doctors use a special catheter to gently treat the nerves near your kidneys. This is done through a small tube inserted into a blood vessel. You would have regular check-ups and your blood pressure monitored closely after the procedure. The total duration of your participation in the study, including follow-up appointments, will be explained in detail by the study team, but generally involves a number of visits over some months.

Potential risks and benefits

Taking part in this study could potentially offer the benefit of better blood pressure control if the Paradise System works well for you. However, as with any medical procedure, there are potential risks, including those associated with the angiogram procedure itself, such as bleeding or infection, or potential issues related to the Paradise System. All procedures carry some risks, and these will be fully explained to you before you decide to take part. Remember, you have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (47)

Cardiology PC
Birmingham, United States
Cedars Sinai Medical Center
Los Angeles, United States
Bridgeport Hospital
Bridgeport, United States
Stamford Hospital
Stamford, United States
MedStar Washington
Washington D.C., United States
The Cardiac and Vascular Institute
Gainesville, United States
Emory University Hospital Midtown
Atlanta, United States
Northwestern University
Chicago, United States
Southern Illinois University
Springfield, United States
Ochsner Heart and Vascular Institute
New Orleans, United States
The Brigham and Women's Hospital
Boston, United States
Munson Medical Center
Traverse City, United States

+35 more sites — see the official record for the full list.

Common questions

What is 'Stage 2 hypertension'?

It means your blood pressure readings are consistently quite high, usually 140/90 mmHg or higher, but not extremely high.

What is the Paradise System?

It's a new device that aims to lower blood pressure by gently treating specific nerves around your kidneys.

Will I have to stop my blood pressure medicines?

Yes, initially you will be asked to stop your blood pressure medications for about four weeks to see the natural level of your blood pressure.

What is a 'renal angiogram'?

It's a medical procedure where doctors look at the blood vessels in your kidneys using X-rays and a special dye.

How long does the study last?

The exact duration will vary by participant, but it involves several appointments over a number of months.