Active not recruitingNAINTERVENTIONAL

Renal Denervation in ADPKD- RDN-ADPKD Study

People with Autosomal Dominant Polycystic Kidney Disease (ADPKD) often have high blood pressure, which can harm their kidneys. This study investigates a procedure called renal denervation (RDN). RDN involves using a special device to calm overactive nerves in the kidneys that can contribute to high blood pressure. The study wants to find out if this procedure is safe and effective in lowering blood pressure in ADPKD patients. Half the participants will have the procedure straight away, and the other half will have it after three months. Researchers will monitor their blood pressure closely to see if the treatment helps and to understand its potential benefits for kidney health.

At a glance

Status

Active not recruiting

Phase

Sponsor

University of Erlangen-Nürnberg Medical School

Enrolment target

Start

14 Jun 2022

Estimated completion

01 Mar 2028

Uncontrolled Hypertension Autosomal Dominant Polycystic Kidney Disease Renal Denervation

What is this study about?

For people living with Autosomal Dominant Polycystic Kidney Disease (ADPKD), high blood pressure is very common and can lead to serious kidney problems over time. Even if their blood pressure is controlled with medication, the 'fight or flight' nerves around the kidneys can sometimes be overactive. This overactivity is thought to play a role in how ADPKD progresses and can even worsen kidney damage.

This study explores a treatment called renal denervation (RDN). RDN is a procedure where a thin, flexible tube (catheter) is guided into the arteries leading to the kidneys. Small bursts of energy are then delivered to gently calm these overactive nerves. The main goal of this particular study is to see if RDN is a safe procedure for people with ADPKD and if it helps to lower their blood pressure. This is an early-stage study, designed to give researchers more information about whether RDN could be a helpful treatment option in the future.

Participants will be split into two groups by chance: one group will receive the RDN procedure right away, and the other group will receive it after three months. This setup allows the researchers to compare how blood pressure changes both short-term and long-term in people who have had the procedure. By carefully tracking blood pressure, they hope to learn whether RDN can make a meaningful difference for ADPKD patients struggling with high blood pressure.

Key takeaways

New study for ADPKD patients with high blood pressure.
Investigating a procedure called renal denervation (RDN).
Aims to see if RDN is safe and lowers blood pressure.
Participation involves a procedure and about three years of follow-up.
Will continue current blood pressure medications.
Focuses on improving heart and kidney health.

Who may be eligible?

To join this study, you need to have Autosomal Dominant Polycystic Kidney Disease (ADPKD) and high blood pressure that isn't fully controlled, even if you're taking medicine for it. Your blood pressure would typically be around 130/80 mmHg or higher in your doctor's office, and a 24-hour home monitor would also show it's elevated. You should be taking blood pressure medication regularly, and your treatment plan should have been stable for at least four weeks before joining. You must be 18 years old or older.

There are also some reasons why you might not be able to join. For example, if your kidney function is too low (eGFR below 40ml/min), or if you have very high blood pressure (180/110 mmHg or higher in the doctor's office) that's considered an emergency. You also can't have certain other conditions, such as Type 1 Diabetes, severe protein in your urine, or if you've already had a heart attack or stroke recently. If you are pregnant or breastfeeding, or planning to become pregnant, you won't be able to participate. The doctors will also check your kidney arteries to make sure the procedure can be done safely.

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.

Do I have Autosomal Dominant Polycystic Kidney Disease (ADPKD)?
Is my blood pressure often 130/80 mmHg or higher, even with medication?
Am I taking blood pressure medication regularly and have my doses been stable for a month?
Am I 18 years old or older?
Is my kidney function (eGFR) 40ml/min or higher?
Am I not pregnant, breastfeeding, or planning to become pregnant?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you'll be randomly assigned to one of two groups. Half the participants will have the renal denervation (RDN) procedure straight away. The other half will wait three months before having the RDN procedure. After your procedure, you'll have regular follow-up visits with the study team for 36 months (three years). These visits will involve monitoring your blood pressure closely, which might include wearing a 24-hour blood pressure monitor, and possibly other tests to check your kidney health. You'll continue to take your current blood pressure medications, and it's important that your medication plan stays stable unless your doctors decide otherwise. The total duration of your participation in the study, including follow-up, will be around three years.

Potential risks and benefits

Participating in this study might offer the benefit of potentially lowering your blood pressure, which could help protect your kidneys from further damage due to ADPKD and high blood pressure. However, like any medical procedure, renal denervation carries potential risks, such as those associated with the catheter procedure itself or potential side effects. These will be fully explained by the study team. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (1)

University Hospital FAU Erlangen-Nürnberg
Verified postcode
Erlangen, Germany

Common questions

What is renal denervation?

It's a procedure where doctors use a special device to calm overactive nerves around your kidneys that can contribute to high blood pressure.

Will I still need to take my blood pressure medication?

Yes, you will continue to take your prescribed blood pressure medications throughout the study.

How long does the study last?

Your involvement in the study, including follow-up appointments, will last for about three years.

What's the difference between the two groups?

One group has the procedure straight away, and the other group has it after three months. This helps researchers compare results.

Is this a new treatment?

While RDN has been studied, this research is specifically looking at its safety and effectiveness in people with ADPKD and high blood pressure.