RecruitingNAINTERVENTIONAL

Randomised Trial Comparing Thermal Ablation With Adrenalectomy in the Treatment of Unilateral Asymmetric PA

This study, called WAVE, is looking at a condition called primary aldosteronism, where an adrenal gland produces too much of a hormone called aldosterone, leading to high blood pressure. Currently, surgery to remove the affected gland is the main treatment. We want to find out if a newer, less invasive treatment called thermal ablation (using heat to treat the gland) works just as well as surgery. We'll compare how well each treatment fixes the hormone problem and improves symptoms. We'll also look at things like how quickly people recover, their quality of life, and any side effects. The goal is to see if thermal ablation can be a good alternative option for patients.

At a glance

Status

Recruiting

Phase

Sponsor

Queen Mary University of London

Enrolment target

122

Start

01 Sep 2022

Estimated completion

01 Sep 2026

Primary Aldosteronism

What is this study about?

You're reading this because you might have a condition called primary aldosteronism (PA). This is a type of high blood pressure caused when one of your small adrenal glands (which sit on top of your kidneys) makes too much of a hormone called aldosterone. This extra hormone can lead to high blood pressure and other issues like low potassium, and it can increase your risk of heart problems.

Currently, if only one adrenal gland is causing the problem, the usual treatment is an operation to remove that gland. This is often done using keyhole surgery. This study, called WAVE, is investigating a different treatment called thermal ablation. This treatment uses heat, often applied with a needle, to destroy the part of the adrenal gland that's making too much hormone, instead of removing the whole gland. We want to see if this less invasive treatment is as good as surgery for helping people with PA.

We'll compare both treatments to see how well they correct the hormone imbalance and improve your overall health. We'll also look at other important things like how soon you can return to your daily activities, your quality of life, and how satisfied you are with your treatment. The aim is to understand if thermal ablation can be a safe and effective option for more patients in the future.

Key takeaways

This study compares two treatments for a type of high blood pressure.
It aims to see if thermal ablation (using heat) works as well as surgery.
The study is for people with too much aldosterone from one adrenal gland.
Participants will be randomly assigned to one of the two treatments.
Researchers will compare how well each treatment fixes the problem and impacts quality of life.
The goal is to find more treatment options for patients in the future.

Who may be eligible?

This study is for adults aged 18 and over who have been diagnosed with primary aldosteronism following international guidelines. This means your doctor will have done specific tests to confirm your diagnosis.

Crucially, we're looking for people where only one adrenal gland is causing the problem, and where scans show a clear, harmless-looking lump on that gland that could be treated by either surgery or thermal ablation. You must be able and willing to understand and sign a consent form to join the study, and your case must have been reviewed and approved by a team of medical specialists.

There are some reasons why you wouldn't be able to join. For example, if you have strong reasons not to have either surgery or thermal ablation, or if you're pregnant or unwilling to use reliable contraception during the study. Also, if you have another serious health condition that limits your life expectancy, or if doctors think your adrenal gland is also making too much of another hormone (cortisol) that would require surgery anyway, you wouldn't be eligible.

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 18 years old or older?
Have you been diagnosed with primary aldosteronism by international standards?
Do scans show that only one adrenal gland is causing the problem?
Are you able and willing to give your informed consent for the study?
Are you able to manage withdrawing certain medications if needed for the study?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be randomly assigned to receive either thermal ablation or surgery to treat your primary aldosteronism. This is like flipping a coin – you wouldn't get to choose which treatment you receive.

After your treatment, you would have several follow-up appointments with the study team. These appointments would involve blood tests, blood pressure checks, and questionnaires to see how you are feeling, your quality of life, and how well the treatment is working. We would also monitor for any side effects. The exact number and timing of visits would be explained in detail by the study team, but they are designed to track your progress over a period of time to compare both treatments thoroughly.

Potential risks and benefits

Taking part in this study may offer potential benefits, such as contributing to scientific understanding that could improve treatment for future patients with primary aldosteronism. You would also receive close monitoring of your condition. However, as with any medical procedure, both surgery and thermal ablation carry potential risks, such as side effects, complications, or the possibility that the treatment might not work as expected. These risks will be fully explained by the study team before you decide to participate. Remember, your participation is voluntary, and you have the right to withdraw from the study at any time without affecting your usual medical care.

Locations (6)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

Cambridge University Hospitals NHS Foundation Trust
Verified postcode
Cambridge, United Kingdom· Recruiting
St Bartholomew's Hospital
Verified postcode
London, United Kingdom· Recruiting
University College London Hospital NHS Foundation Trust
Verified postcode
London, United Kingdom· Recruiting
Guy's and St Thomas' NHS Foundation Trust
Verified postcode
London, United Kingdom· Recruiting
Imperial College Healthcare NHS Trust
Verified postcode
London, United Kingdom· Recruiting
Sheffield Teaching Hospitals NHS Foundation Trust
Verified postcode
Sheffield, United Kingdom· Recruiting

Common questions

What is primary aldosteronism?

It's a condition where one or both of your adrenal glands make too much of a hormone called aldosterone, which can cause high blood pressure and other issues.

What is thermal ablation?

It's a treatment that uses heat, often delivered by a needle, to destroy a small part of the adrenal gland that's producing too much hormone.

What is unilateral adrenalectomy?

This is surgery to remove the single adrenal gland that is causing the problem, usually done with keyhole surgery.

Will I get to choose my treatment?

No, if you join the study, you will be randomly assigned to receive either thermal ablation or surgery, like drawing lots or flipping a coin.

What does non-inferior mean?

It means the study aims to show that thermal ablation is not worse than surgery in treating the condition, and ideally, just as good or even better.

How to find out more

Aklima Khatun

aklima.khatun4@nhs.net 0203 765 8577 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.