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Study of prednisone and azathioprine treatment in patients with virus-negative myocarditis or inflammatory heart muscle disease with reduced heart pump function

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What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on myocarditis and inflammatory cardiomyopathy, which are conditions where the heart muscle becomes inflamed. The research aims to evaluate how effective certain medications are in treating these heart conditions when there is no virus present in the heart tissue. The medications being tested are prednisone and azathioprine, which are drugs that reduce the body's immune response, along with placebo.

The study will examine patients who have inflammation of the heart muscle and reduced heart function, specifically looking at how well the heart pumps blood. The medications will be given as tablets that are taken by mouth. The treatment period lasts for 12 months, during which patients will receive either the study medications or placebo in addition to their standard heart treatment.

After the initial 12-month treatment period, patients will be monitored for another 12 months to see if the effects of the treatment continue. Throughout the study, various measurements will be taken to check heart function and track how well the treatment is working. The study uses special heart tests to monitor the condition of the heart muscle and measure how effectively it pumps blood.

The research process

The trial runs in 4 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Initial examination and medication start
After joining the study, you will receive either active treatment or placebo (inactive substance that looks like the medication).
The active treatment consists of two medications: prednisone (tablets of 5mg or 10mg) and azathioprine (50mg tablets), both taken by mouth.
These medications help reduce inflammation in the heart muscle by lowering the body's immune response.
Step 2
Treatment period - first 12 months
You will take the prescribed medications or placebo daily for 12 months.
During this period, doctors will monitor your heart function through regular examinations.
The main focus will be on measuring your heart ejection fraction (the amount of blood your heart pumps out with each beat).
Regular checks will include measuring the size of your heart chambers and assessing your physical condition.
Step 3
Follow-up period - months 13-24
After the initial 12-month treatment period, monitoring will continue for another 12 months.
During this time, doctors will continue to check your heart function and overall health.
The focus will remain on measuring your heart ejection fraction and heart chamber sizes.
Your physical condition will be regularly assessed to track any changes.
Step 4
Final evaluation
At the end of the 24-month period, a final assessment of your heart function will be conducted.
This will help determine if the treatment effects have been maintained or improved over time.
The evaluation will include measurements of your heart function and physical condition assessment.

Who can join the trial?

8 criteria

Must sign a written consent form to participate in the study, including agreement to undergo two EMBs (heart tissue samples) and two CMRs (cardiac magnetic resonance imaging)
Must be diagnosed with active myocarditis (heart muscle inflammation) or inflammatory cardiomyopathy (heart muscle disease), either: - Currently undergoing diagnosis with heart tissue biopsy, or - Already confirmed by heart tissue biopsy within the last 3 months
Age requirement: between 18 and 65 years old
For women who can become pregnant: - Must have a negative pregnancy test - Must use effective birth control throughout the study and for 8 weeks after - Or be post-menopausal for at least 1 year - Or have had surgical sterilization
Must show no significant improvement in condition despite standard treatment for at least 3 months before screening
Must have a left ventricular ejection fraction (LVEF) between 10-45% (measure of heart pumping function) with: - No significant improvement in the last 3 months - Measurement taken under stable conditions
Must have confirmed active myocarditis or inflammatory cardiomyopathy through heart tissue examination
Must test negative for heart-affecting viruses in heart tissue sample

Who cannot join the trial?

13 criteria

Patients with viral myocarditis (heart muscle inflammation caused by a virus)
Patients with heart function below 10% or above 45% (as measured by left ventricular ejection fraction)
Persons under 18 years of age
Known allergies or hypersensitivity to prednisone (a steroid medication) or azathioprine (an immunosuppressant drug)
Pregnant or breastfeeding women
Active infections that require treatment
History of autoimmune diseases (conditions where the immune system attacks healthy body tissues)
Severe kidney or liver disease
Recent heart attack within the past 30 days
Current participation in other clinical trials
History of cancer in the past 5 years
Inability to provide informed consent
Conditions that could interfere with study procedures or follow-up

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Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Gornoslaskie Centrum Mwdyczne
Verified
Katowice, Poland
Samodzielny Publiczny Zaklad Opieki Zdrowotnej Centralny Szpital Kliniczny Uniwersytetu Medycznego W Lodzi
Responsive
Lodz, Poland
Uniwersyteckie Centrum Kliniczne Warszawskiego Uniwersytetu Medycznego
Responsive
Warsaw, Poland

Trial locations

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Investigated drugs

Prednisone This is a corticosteroid medication that helps reduce inflammation in the body. In this trial, it's used to suppress the immune system response in patients with heart muscle inflammation (myocarditis) when no virus is present. It helps decrease inflammation in the heart muscle. Azathioprine This is an immunosuppressive medication that works by decreasing the activity of the body's immune system. In this trial, it's used together with prednisone to help treat inflammation of the heart muscle in cases where no virus is causing the condition. It helps prevent the immune system from attacking healthy heart tissue. Both medications are being tested alongside standard heart failure treatments to see if they can improve heart function in patients with myocarditis or inflammatory cardiomyopathy where their heart is not pumping blood as effectively as it should.

What is already known about the treatment

Prednisone
A synthetic corticosteroid medication that is taken orally in tablet form and works by suppressing the immune system and reducing inflammation throughout the body. This widely-used drug is a standard treatment for various inflammatory conditions, including myocarditis and inflammatory cardiomyopathy, where it helps reduce heart muscle inflammation. Prednisone belongs to the glucocorticoid class of medications and works by binding to specific receptors in cells to decrease the production of inflammatory substances and immune system activity.
Azathioprine
An oral immunosuppressive medication that is used to prevent organ rejection and treat various autoimmune conditions, including inflammatory heart conditions. The medication works by interfering with DNA synthesis in immune cells, thereby reducing the body's immune response and inflammation. Azathioprine belongs to the antimetabolite class of drugs and is often used in combination with other immunosuppressive medications like prednisone for enhanced therapeutic effect in treating inflammatory conditions.

Investigated diseases

Myocarditis
An inflammatory condition of the heart muscle (myocardium) that can affect the heart's ability to pump blood effectively. The inflammation can weaken the heart muscle, leading to reduced heart function. It can develop suddenly or progress gradually over time.
Inflammatory Cardiomyopathy
A condition where inflammation of the heart muscle leads to enlarged, thickened, or stiffened heart chambers. This causes the heart to become weaker and less efficient at pumping blood. The condition can develop from myocarditis and results in changes to the heart's structure and function.