Not yet recruitingNAINTERVENTIONAL

Endovascular Ablation of the Right Greater Splanchnic Nerve in Subjects With Reduced Ejection Fraction

This is an early-stage study for people with heart failure where the heart struggles to pump blood (called HFrEF). Researchers are testing a new procedure that uses a thin tube, called a catheter, to treat a specific nerve in the chest (the right greater splanchnic nerve). The main goal is to find out if this treatment is safe and if it might show early signs of helping people feel better. About 50 volunteers, aged 40 or over, will take part in hospitals worldwide. Some will get the real treatment, and others will get a 'sham' procedure that looks and feels similar but isn't active. This helps researchers compare results fairly and understand if the treatment truly works. The study also aims to figure out who might benefit most in the future.

At a glance

Status

Not yet recruiting

Phase

Sponsor

Axon Therapies, Inc.

Enrolment target

Start

01 Mar 2026

Estimated completion

01 Sep 2028

Heart Failure With Reduced Ejection Fraction (HFrEF)

What is this study about?

Imagine your heart struggles to pump blood around your body – this is called heart failure, and if it's because the pumping action is weaker than it should be, doctors call it "heart failure with reduced ejection fraction" (HFrEF).

This study is looking at a new way to help people with HFrEF. It involves a procedure that uses a special tube (called a catheter) to treat a nerve in the chest called the right greater splanchnic nerve. We know that nerves play a big role in how our bodies function, and some researchers believe this particular nerve might be involved in heart failure symptoms. The hope is that by treating this nerve, it could help improve how people with heart failure feel.

This is a small, early study, which means the main focus is on making sure the procedure is safe and looking for any early signs that it might be helpful. It's not designed to prove it's a long-term cure, but rather to see if it's promising enough to be studied more widely in the future. Researchers are also trying to understand which patients might benefit the most from this kind of treatment.

Key takeaways

This is an early study testing a new procedure for heart failure (HFrEF).
It aims to check safety and if the treatment shows early promise.
A special tube is used to treat a nerve in the chest.
Participants will either get the real treatment or a 'sham' procedure.
Neither you nor your family doctor will know which treatment you received.
It's for people aged 40 and over with stable heart failure medication.

Who may be eligible?

To join this study, you would typically need to meet certain conditions related to your heart failure. You should have ongoing symptoms that need treatment with water tablets (diuretics) and have been managing your heart failure with standard medications for at least a month. Your doctor will check your symptoms and do blood tests to confirm your heart condition.

You also need to be at least 40 years old. An important part of the study is that you shouldn't have recently started certain new diabetes or weight loss medications (like GLP-1 or GIP agonists) or be planning to start them within the next six months. Your heart failure doctor will carefully review all your current medications to make sure they are stable and appropriate for the study.

The research team will carry out several checks and tests to make sure that taking part in this study is suitable and safe for you. They will look at your overall health, including any other medical conditions you have, to make sure this study is the right fit. Both men and women can take part in this research.

Quick self-check

Are you at least 40 years old?
Do you have heart failure with reduced pumping ability (HFrEF)?
Are you currently taking water tablets (diuretics) for your heart failure symptoms?
Have you been on stable heart failure medications (like ACE inhibitors/ARBs/ARNIs and beta-blockers) for at least the last month?
Have you *not* started certain new diabetes or weight loss medications (GLP-1/GIP agonists) in the last 6 months, and don't plan to in the next 6 months?

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

What does participation involve?

Taking part in this study means you will be followed closely by the study team. You might have several hospital visits for assessments, including checks of your heart failure symptoms, blood tests, and possibly scans. You will continue to take your regular heart failure medications as prescribed by your doctor. The study procedure itself is done under anaesthesia or sedation and involves either the actual nerve treatment or a 'sham' (dummy) procedure, which takes about 45 minutes.

Neither you nor your usual heart doctor will know whether you received the real treatment or the sham — this is important for getting unbiased results. However, the doctor performing the procedure will know for safety reasons. You will be followed over a period to see how you are doing, with check-ups at specific times. The exact number of visits and the total duration of your participation will be explained in detail by the study team.

Potential risks and benefits

As with any medical procedure, there are potential risks, side effects, or discomfort from the procedures involved, including those from anaesthesia or sedation. Your doctors will discuss these in detail. On the other hand, you might experience an early improvement in your heart failure symptoms or overall well-being, though this is not guaranteed, especially since some participants will receive a sham procedure. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (6)

Motol and Homolka University Hospital
Prague, Czechia
Uniwersytecki Szpital Kliniczny im. Jana Mikulicza Radeckiego we Wrocławiu
Wroclaw, Poland
Hospital Clínico Universitario de Valencia-INCLIVA
Valencia, Spain
Vithas Valencia Turia
Valencia, Spain
Leeds General Infirmary
Leeds, United Kingdom
King's College London
London, United Kingdom

Common questions

What is 'heart failure with reduced ejection fraction' (HFrEF)?

It means your heart muscle is weakened and doesn't pump blood as strongly as it should, leading to symptoms like breathlessness and tiredness.

What is a 'sham control' procedure?

It's a dummy procedure designed to look and feel like the real treatment but without delivering the actual active treatment. This helps researchers compare true treatment effects fairly.

Will I know if I got the real treatment?

No, neither you nor your regular heart doctor will know if you received the real treatment or the sham procedure. This helps ensure the study results are reliable.

What does 'early-stage' mean for this study?

It means the main goals are to check the safety of the new procedure and look for initial signs that it might be helpful, rather than proving it's a long-term solution just yet.

What is the 'right greater splanchnic nerve'?

It's a nerve in your chest that researchers believe might play a role in heart failure symptoms. This study aims to understand if treating it can help.

How to find out more

Judit Adorjan

j.adorjan@axontherapies.com +1 650 722-1119 Official trial record

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