RecruitingOBSERVATIONAL

Clinical Phenotypes in Pericarditis: IL-1RA Antibodies and suPAR Levels

This research aims to understand why some people suffer from recurrent pericarditis, a condition where the protective sac around the heart becomes inflamed repeatedly. Scientists believe that different things might cause this in different people. This study will check for special antibodies (called IL-1RA antibodies) and a protein marker (called suPAR) in the blood. They hope these tests will help them tell the difference between various types of pericarditis, including those where inflammatory processes are very active and those where they are not. The findings could help doctors decide if a specific medicine, like anakinra, would be a good treatment for a patient and lead to better ways to manage this ongoing heart condition.

At a glance

Status

Recruiting

Sponsor

ASST Fatebenefratelli Sacco

Enrolment target

146

Start

01 Jul 2023

Estimated completion

20 Dec 2025

Pericarditis

What is this study about?

Pericarditis is a condition where the thin, fluid-filled sac surrounding your heart (called the pericardium) becomes inflamed. When this happens over and over again, it's called recurrent pericarditis (RP). It can cause chest pain and greatly impact a person's life, sometimes leading to more serious heart problems. Right now, it's not always clear why some people get RP and others don't, or why certain treatments work better for some.

This study is trying to get a clearer picture of what's happening inside the body when someone has recurrent pericarditis. We know that the body's immune system plays a big role in inflammation. Researchers will look for specific antibodies in the blood that are known to be involved in severe inflammation. They will also measure levels of a protein called suPAR. By testing for these substances, the study hopes to discover if there are different underlying reasons or 'types' of recurrent pericarditis, even if they look similar on the surface.

The main goal is to figure out if these tests can help doctors understand which type of pericarditis a person has. This information could be very important for choosing the best treatment. For example, if certain antibodies are found, it might mean that a particular medicine called anakinra (which works by targeting inflammation) could be very effective. Ultimately, this research aims to improve how recurrent pericarditis is diagnosed and treated, helping patients feel better and live healthier lives.

Key takeaways

This study investigates why some people repeatedly get pericarditis.
It aims to find different 'types' of pericarditis using new blood tests.
The research looks for specific antibodies and a protein called suPAR.
Findings could lead to more personalised and effective treatments.
It might help doctors decide if medicines like anakinra are suitable for you.
Participation involves blood tests during flare-ups and possibly between them.

Who may be eligible?

This study is looking for adults aged 18 to 90 who are currently experiencing a flare-up of recurrent pericarditis. To be included, your pericarditis diagnosis needs to meet specific medical criteria, such as having typical chest pain or changes seen on heart tests. If you've had pericarditis after heart surgery or an injury, and it's new or getting worse, you might also be able to join.

Researchers will also be interested in your past medical history, specifically your CRP levels. CRP is a marker of inflammation in the body. They want to see if your CRP levels have been very high during previous pericarditis episodes or if they usually stay normal. This helps them understand different types of inflammation.

However, some people won't be able to join. This includes anyone under 18, pregnant or breastfeeding women, or those with certain other medical conditions like tuberculosis, some cancers, or autoimmune diseases. If you have a weakened immune system, you would also not be able to take part.

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?
Are you currently experiencing an episode of recurrent pericarditis?
Has your doctor confirmed your pericarditis diagnosis using specific criteria?
Do you have a history of your CRP levels during previous pericarditis episodes?
Are you NOT pregnant or breastfeeding?
Do you NOT have conditions like tuberculosis, certain cancers, or autoimmune diseases?

Answer every question to see your result.

What does participation involve?

The detailed involvement for participants isn't fully described in the summary provided. However, generally, taking part in a study like this would likely involve providing blood samples during an acute flare-up of your pericarditis, and possibly again when you are feeling better (during 'intercritical phases'). These blood samples would be used to measure the specific antibodies and suPAR levels mentioned in the study. You would also likely have standard heart and inflammation markers checked, as part of your regular care, which the study would use to compare with the new test results. The total duration of your participation would depend on how often you have recurrences and how long the researchers need to follow your condition.

Potential risks and benefits

Potential benefits of taking part include contributing to a better understanding of recurrent pericarditis, which might lead to improved treatments for future patients, and potentially for yourself, if the findings help guide your care. The risks are generally low, mainly related to blood draws, which can cause minor discomfort, bruising, or rarely, infection. You might also have additional doctor visits. It's important to remember that you can stop being part of the study at any time, for any reason, without it affecting your usual medical care.

Locations (9)

Saarland University
Verified postcode
Homburg, Germany· Recruiting
University Children's Hospital Muenster
Verified postcode
Münster, Germany· Not yet recruiting
University Hospital Tübingen
Verified postcode
Tübingen, Germany· Not yet recruiting
A.O.U. Careggi
Verified postcode
Florence, Italy· Not yet recruiting
Luigi Sacco Hospital - ASST Fatebenefratelli Sacco
Verified postcode
Milan, Italy· Recruiting
Fatebenefratelli Hospital - ASST Fatebenefratelli Sacco
Verified postcode
Milan, Italy· Recruiting
Ospedale Galeazzi Sant'Ambrogio - IRCCS, Poliambulatorio Cardiovascolare Cardiologia Universitaria
Verified postcode
Milan, Italy· Not yet recruiting
Policlinico di Milano Ospedale Maggiore, Fondazione IRCCS Ca' Granda
Verified postcode
Milan, Italy· Not yet recruiting
Ospedale Santa Maria della Misericordia dell'ASU-FC
Verified postcode
Udine, Italy· Not yet recruiting

Common questions

What is pericarditis?

Pericarditis is when the protective sac around your heart becomes inflamed, often causing chest pain.

What does 'recurrent' mean in this study?

Recurrent means that you experience episodes of pericarditis that keep coming back, even after treatment.

What kind of tests will be done?

The study will involve blood tests to look for specific antibodies and a protein marker called suPAR, along with standard inflammation checks.

Will taking part help me personally?

While the main goal is to help future patients, the insights gained might also help your doctor tailor your treatment. You'll also be contributing to important medical research.

What is anakinra?

Anakinra is a medicine that helps reduce inflammation in the body by blocking certain signals from the immune system.

How to find out more

Maddalena A Wu

maddalena.wu@unimi.it +393392883379 Official trial record

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