Renal Artery DenervatIon Using Radial accesS in Uncontrolled HyperTensioN
This study is investigating a new treatment for people whose high blood pressure isn't well controlled, even after taking several medications. The treatment is called renal denervation, and it involves using a special device to reduce the activity of nerves in the kidneys that can contribute to high blood pressure. Traditionally, doctors access these kidney nerves through a blood vessel in the leg (femoral access). This study is comparing this traditional method with a newer approach where doctors access the blood vessels through the wrist (radial access). We want to find out if this wrist-based method is just as safe and works just as well as the leg-based method, potentially offering a less invasive option for patients. The study will involve 90 patients across Europe and will follow them for 6 months.
At a glance
What is this study about?
This study is designed for individuals who have tried several blood pressure medications, but their high blood pressure (also known as hypertension) is still not at a healthy level. High blood pressure can lead to serious health problems like heart attacks and strokes, so finding effective treatments is very important.
The treatment being studied is called renal denervation. This is a procedure where doctors use a special tiny device to quiet down certain nerves in the kidney arteries. These nerves can play a role in blood pressure regulation, and by calming them, we hope to help lower blood pressure. The main goal of this particular study is to compare two different ways of performing this procedure. One way, which is more common, involves guiding the device through a blood vessel in your groin (femoral access). The other, newer way, uses a blood vessel in your wrist (radial access).
We want to see if the wrist-based approach is just as safe and effective as the groin-based approach. The idea is that using the wrist might be a more comfortable and less complicated experience for patients. By comparing these two methods, we hope to improve how this important treatment is given in the future.
Key takeaways
- Exploring a new way to treat persistent high blood pressure.
- Compares two ways of performing a procedure called renal denervation.
- Aims to see if a wrist-based approach is as good as a groin-based approach.
- Involves 90 patients with uncontrolled high blood pressure.
- Follow-up for 6 months after the procedure.
- Could help improve future treatment options for high blood pressure.
Who may be eligible?
To join this study, you would generally need to be between 18 and 75 years old. Your blood pressure needs to be consistently high, even though you are already taking 2 to 5 different medications for it. Specifically, your blood pressure measured in the doctor's office should be above 150/80 mmHg, and your daytime blood pressure at home should be 140 mmHg or higher.
There are also some medical checks: the blood vessels leading to your kidneys need to be of a certain size (between 3mm and 8mm), and you must be suitable for both the groin and wrist access methods. You also need to be able to understand what the study involves and agree to take part by signing a consent form.
You would not be able to join if your kidney function is very low, or if you've had a kidney transplant in the past. If you have extra kidney arteries that are too small to treat, or if you're participating in another experimental drug or device study, you wouldn't be eligible. Pregnant or breastfeeding women, or those planning to become pregnant during the study, also cannot take part, nor can individuals who are unable to give informed consent, for example due to conditions like dementia.
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?
- Is your high blood pressure still high even though you take 2-5 medications for it?
- Have you been told you have good kidney function?
- Have you never had a kidney transplant?
- Are you able to understand and agree to take part in a study?
What does participation involve?
If you join this study, you will be randomly assigned to receive the renal denervation procedure using either the groin (femoral) access or the wrist (radial) access method. This is like flipping a coin to decide which group you're in. The procedure is performed using special equipment to calm nerves in your kidney arteries.
After the procedure, you will follow a standard care plan with your doctor. You'll have follow-up visits to check on your health and blood pressure at 3 months and 6 months after the procedure. These visits usually involve checking your blood pressure, and potentially some blood tests.
In total, the study expects to enroll patients over about 27 months, and the entire study, from beginning to end for all patients, is estimated to last around 38 months.
Potential risks and benefits
Locations (11)
- Hôpital Saint AndréVerified postcodeBordeaux, France· Recruiting
- Hôpital Jacques CartierVerified postcodeMassy, France· Recruiting
- Centre Hospitalier de PauVerified postcodePau, France· Recruiting
- Clinique PasteurVerified postcodeToulouse, France· Recruiting
- Zentrum für klinische Prüfungen in der Facharztzentrum Dresden Neustadt GbRVerified postcodeDresden, Germany· Recruiting
- Asklepios Klinik AltonaVerified postcodeHamburg, Germany· Recruiting
- Saarland University HospitalVerified postcodeHomburg, Germany· Recruiting
- Johanniter-Krankenhaus Genthin-StendalVerified postcodeStendal, Germany· Recruiting
- University Hospital BaselVerified postcodeBasel, Switzerland· Not yet recruiting
- University & Hospital FribourgVerified postcodeFribourg, Switzerland· Not yet recruiting
- Cardiovascolare Istituto Cardiocentro TicinoVerified postcodeLugano, Switzerland· Not yet recruiting
Common questions
What is 'renal denervation'?
It's a medical procedure that uses a special device to calm specific nerves near your kidneys that can contribute to high blood pressure.
Why are doctors looking at different ways to do this procedure?
They want to see if using a blood vessel in the wrist (radial access) is as safe and effective as using one in the groin (femoral access), hoping it might be a more comfortable option.
Will I get to choose which access method I receive?
No, you will be randomly assigned to one of the two methods, just like flipping a coin.
How long will I be involved in the study?
After your procedure, you'll have follow-up visits for 6 months.
What if my blood pressure doesn't get better?
There's no guarantee the treatment will work for everyone, but all patients continue to receive standard medical care during the study.
How to find out more
Bradley S Hubbard, DVM
Always speak to your GP or specialist before deciding to take part in a study.
Interested in taking part?
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