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Study on Anakinra for Treating Inflammatory Dilated Cardiomyopathy in Patients: Evaluating Efficacy and Safety of Anakinra with Standard Care vs. Standard Care Alone

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What is this trial about?

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

This clinical trial is focused on studying a heart condition known as inflammatory dilated cardiomyopathy. This condition affects the heart's ability to pump blood effectively due to inflammation, leading to symptoms like fatigue and shortness of breath. The trial will test a treatment called anakinra, which is a medication designed to reduce inflammation by blocking a specific protein in the body. The study will compare the effects of anakinra combined with standard heart care to standard heart care alone.

The purpose of the study is to evaluate whether anakinra can improve heart function in patients with inflammatory dilated cardiomyopathy. Participants will receive either anakinra or a placebo, in addition to their usual heart treatment. The study will last for a period of 12 weeks, during which participants will be monitored to assess any changes in their heart's ability to pump blood, measured by a test called transthoracic echocardiography (TTE). This test uses sound waves to create images of the heart and evaluate its function.

Throughout the study, participants will have regular check-ups to monitor their health and the effects of the treatment. The goal is to determine if anakinra can help improve the heart's pumping ability, which is measured by the left ventricular ejection fraction (LVEF). This trial aims to provide valuable information on the potential benefits of anakinra for patients with this specific type of heart disease.

The research process

The trial runs in 6 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Joining the study
Upon joining the study, eligibility is confirmed based on specific criteria such as age, diagnosis of dilated cardiomyopathy, and other health conditions.
Informed consent is signed, indicating understanding and agreement to participate in the trial.
Step 2
Initial assessment
An initial assessment is conducted, which includes a review of medical history and current symptoms.
Tests such as echocardiography and possibly cardiac MRI are performed to evaluate heart function and inflammation.
Step 3
Randomization
Participants are randomly assigned to one of two groups: one receiving anakinra plus standard care, and the other receiving standard care alone.
This process is double-blind, meaning neither the participant nor the researchers know which group the participant is in.
Step 4
Treatment phase
If assigned to the anakinra group, the medication is administered through subcutaneous injection.
The dosage and frequency of anakinra are determined by the study protocol and are followed for a duration of 4 weeks.
Step 5
Follow-up assessments
Regular follow-up assessments are conducted to monitor health and heart function.
Echocardiography is used to measure the improvement in heart function, specifically the left ventricular ejection fraction.
Step 6
Completion of the trial
At the end of the 4-week period, a final assessment is conducted to evaluate the overall impact of the treatment.
Participants are provided with information about the results and any further steps if necessary.

Who can join the trial?

8 criteria

Age between 18 and 75 years old.
Have a diagnosis of DCM (dilated cardiomyopathy) according to current guidelines.
Have symptoms of HF (heart failure) that have not improved or have worsened despite at least 3 months of optimal therapy.
Have a LVEF (Left Ventricular Ejection Fraction) of less than 50% as shown by an echocardiogram (a heart ultrasound), which has not improved or has worsened despite at least 3 months of optimal therapy.
Have increased levels of high-sensitive troponin T (hs-TnT) (a protein that indicates heart muscle damage) and/or signs of current or past heart muscle inflammation on a cardiac MRI (a detailed heart scan) within the last 6 months.
No presence of coronary artery disease, which means no significant narrowing (more than 50%) of the coronary arteries as shown by an angiography or coronary CT scan, if done in the last 12 months.
Ability to sign an informed consent form, which means understanding the study and agreeing to participate.
For a specific part of the study (Phase IIa), there must be more than 7 CD3+ cells per mm² on an EMB (endomyocardial biopsy), in addition to all the other criteria listed above.

Who cannot join the trial?

9 criteria

Patients with any other heart condition besides inflammatory dilated cardiomyopathy cannot participate. This is a specific heart condition where the heart becomes enlarged and inflamed, affecting its ability to pump blood.
Patients who are not within the age range of 18 to 65 years old are excluded.
Patients who are pregnant or breastfeeding cannot participate.
Patients with a history of severe allergic reactions to the study medication, Anakinra, are excluded. Anakinra is a medication used to block certain proteins in the body that can cause inflammation.
Patients with active infections or a history of recurrent infections are not eligible.
Patients with a history of cancer within the last 5 years, except for certain skin cancers, are excluded.
Patients who have received another investigational drug within the last 30 days cannot participate.
Patients with severe liver or kidney disease are excluded.
Patients with any condition that, in the opinion of the study doctor, would make participation unsafe or affect the study results are not eligible.

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Ospedale San Raffaele S.r.l.
Milan, Italy

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Investigated drugs

Anakinra is a medication used in this clinical trial to help treat inflammation. It works by blocking a specific protein in the body called interleukin-1 (IL-1), which is involved in causing inflammation. In this study, Anakinra is being tested to see if it can improve the function of the heart in patients with a condition called dilated cardiomyopathy. The researchers want to find out if Anakinra can help the heart pump blood more effectively by reducing inflammation.

Anakinra

What is already known about the treatment

Anakinra – Anakinra is administered as an injection under the skin, typically in the abdomen, thigh, or upper arm. It is currently being studied for its effectiveness in treating inflammatory dilated cardiomyopathy, a condition where the heart becomes enlarged and inflamed, affecting its ability to pump blood. Anakinra works by blocking a protein called interleukin-1 (IL-1), which plays a role in inflammation, thereby potentially reducing heart inflammation and improving heart function. It is classified as an interleukin-1 receptor antagonist, a type of medication that interferes with the inflammatory process.

Investigated diseases

Inflammatory dilated cardiomyopathy – This disease is characterized by the enlargement and weakening of the heart's main pumping chamber, the left ventricle, due to inflammation. The inflammation can lead to a reduction in the heart's ability to pump blood effectively, causing symptoms such as fatigue, shortness of breath, and swelling in the legs and feet. Over time, the heart muscle may become progressively weaker, leading to further dilation of the heart chambers. This can result in an irregular heartbeat and the potential for blood clots to form. The condition can also cause fluid buildup in the lungs and other parts of the body. The progression of the disease can vary, with some individuals experiencing a gradual worsening of symptoms.