Ongoing, recruitingHuman Pharmacology (Phase I)- OtherInterventional

Impact of CardiolRxTM on Recurrent Pericarditis: An open label Pilot Study

This clinical trial is investigating a new medication called CardiolRxTM for individuals suffering from recurrent pericarditis. Pericarditis is a condition where the sac around your heart becomes inflamed, causing chest pain. When it keeps coming back, it's called recurrent pericarditis. This study is an early-stage, 'open label' trial, meaning both participants and researchers will know who is receiving the new treatment. The main goal is to carefully observe how the treatment works in people, particularly focusing on its safety and any side effects. It's a pilot study, which means it's a small initial look to gather important information before potentially moving on to larger studies.

At a glance

Status

Ongoing, recruiting

Phase

Human Pharmacology (Phase I)- Other

Sponsor

Cardiol Therapeutics Inc.

Enrolment target

Start

05 Jan 2024

Recurrent Pericarditis

What is this study about?

Imagine your heart is a precious gift wrapped in a protective bag. This bag is called the pericardium. Sometimes, this bag can get inflamed, causing a lot of chest pain and discomfort. This condition is known as pericarditis. For some people, this inflammation keeps coming back, which is called recurrent pericarditis. It can be very frustrating and painful, impacting daily life.

This particular study is looking at a new treatment called CardiolRxTM. The aim is to see if this new medication can help people with recurrent pericarditis. Because it's a new treatment, researchers need to be very careful and start with small studies. This study is an 'open label' trial, which means everyone involved – both the patients taking part and the doctors – will know that the CardiolRxTM treatment is being given. This allows the medical team to closely watch how people react to the new treatment.

The main purpose of this study is to learn more about how CardiolRxTM works in the human body, especially to make sure it's safe. It's like taking the first careful steps to see if a new pathway is safe to walk on. The information gathered from this pilot study will help doctors understand promising new ways to treat recurrent pericarditis in the future.

Key takeaways

This study is testing a promising new treatment for recurrent pericarditis.
It's an early-stage study, focusing on safety and how the medication works.
Both men and women aged 18 and over can potentially take part.
Participation involves taking medication and regular medical check-ups.
You have the right to withdraw from the study at any point.

Who may be eligible?

To be considered for this study, you must be an adult aged 18 years or older. There is no upper age limit, meaning that older adults are also welcome to participate.

This study is open to both men and women. The researchers are looking for a diverse group of people to join. Because it's an early-stage study, the specific details about your health condition for you to be able to join will be discussed thoroughly with you by the study team. They will ensure it's suitable for you.

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?
Do you have recurrent pericarditis?
Are you able to attend regular study appointments?
Are you comfortable potentially taking a new, experimental medication?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you would be taking a new medication called CardiolRxTM. The study is 'open-label', which means everyone will know you are receiving this specific treatment. You would have regular appointments with the study doctors and nurses. These visits would involve health checks, likely including blood tests, heart rhythm checks (like an ECG), and discussions about how you are feeling and any side effects you might experience. The total duration of your participation, including how often you'd need to visit, would be fully explained to you before you agree to join.

Potential risks and benefits

Participating in this study might offer a potential benefit: you could receive a new treatment for your recurrent pericarditis that isn't widely available yet, which might help your symptoms. However, as with any new medication, there are always potential risks, including side effects that are not yet fully known. The study team will explain all known risks to you. Remember, you can choose to leave the study at any time, for any reason, without it affecting your usual medical care.

Locations (1)

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

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Unverified
France

Common questions

What is pericarditis?

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

What does 'recurrent' mean?

Recurrent means that the pericarditis keeps coming back even after it gets better.

What is CardiolRxTM?

CardiolRxTM is the name of the new medication being tested in this study for recurrent pericarditis.

Is this a new treatment?

Yes, this is an early-stage study to see how a new treatment called CardiolRxTM works in people.

Can I leave the study if I change my mind?

Yes, you can choose to stop participating in the study at any time, for any reason.