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Targeted therapy with anakinra for dilated cardiomyopathy: phase IIa randomized double blind monocentric clinical trial to evaluate the efficacy and safety of anakinra plus standard of care vs standard of care alone in the treatment of dilated cardiomyopathy.
EU CTIS ID: 2024-514861-21-00
What this study is testing
To evaluate the efficacy of IL-1 therapeutic blockade with Anakinra in improving Left Ventricular Ejection Fraction (LVEF) assessed by Trans Thoracic Echocardiograhy (TTE) at 4 weeks.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Age: 18 Years to 75 years;
- Diagnosis of DCM according to current guidelines;
- Symptoms of HF not improved or worsened despite at least 3 months of optimal therapy;
- LVEF<50% at echocardiography (TTE), not improved or worsened despite at least 3 months of optimal therapy;
- Increased high-sensitive troponin T (hs-TnT), and/or findings suggestive for actual or prior myocardial inflammation at cardiac MRI (within 6 months);
- Absence of coronary artery disease (coronary artery stenosis > 50% at angiography or coronary CT Scan, acceptable if performed during the last 12 months).
You likely can't join if
- Genetic DCM;
- Hepatic impairment = Child-Pugh Class C;
- Mechanical ventilation circulatory assistance;
- Pregnancy, breastfeeding. Female patients of childbearing potential may participate if adequate contraception is used during the study. (For the purposes of this trial, women of childbearing potential are defined as “All female subjects after puberty unless they are post-menopausal for at least 2 years or are surgically sterile.”)
- Contra-indication to ANAKINRA (known hypersensitivity to the active substance or to any of the excipients or to Escherichia coli-derived proteins).
- Presence of neutropenia < 1,5.109/L), or thrombocytopenia < 50.000/mm3;
See the full eligibility criteria
Who can join
- Age: 18 Years to 75 years;
- Diagnosis of DCM according to current guidelines;
- Symptoms of HF not improved or worsened despite at least 3 months of optimal therapy;
- LVEF<50% at echocardiography (TTE), not improved or worsened despite at least 3 months of optimal therapy;
- Increased high-sensitive troponin T (hs-TnT), and/or findings suggestive for actual or prior myocardial inflammation at cardiac MRI (within 6 months);
- Absence of coronary artery disease (coronary artery stenosis > 50% at angiography or coronary CT Scan, acceptable if performed during the last 12 months).
- Ability to sign an informed consent;
- Presence of CD3+ >7/mm2 cells on EMB, in addiction to all the aformentioned inclusion criteria, will be needed exclusively to be enrollend in the Phase IIa Randomized Double Blind monocentric Clinical Trial.
What rules you out
- Genetic DCM;
- Hepatic impairment = Child-Pugh Class C;
- Mechanical ventilation circulatory assistance;
- Pregnancy, breastfeeding. Female patients of childbearing potential may participate if adequate contraception is used during the study. (For the purposes of this trial, women of childbearing potential are defined as “All female subjects after puberty unless they are post-menopausal for at least 2 years or are surgically sterile.”)
- Contra-indication to ANAKINRA (known hypersensitivity to the active substance or to any of the excipients or to Escherichia coli-derived proteins).
- Presence of neutropenia < 1,5.109/L), or thrombocytopenia < 50.000/mm3;
- Any comorbidity limiting survival or conditions predicting inability to complete the study;
- Any concomitant immune-suppressive medications (i.e. azathioprine, methotrexate, cyclosporine, mycophenolate, cyclophosphamide, rituximab, tacrolimus);
- Therapy with prednisone >10 mg daily and/or any immuno-suppressive agents within 3 months before the enrolment;
- Congenital and/or acquired valvular disease or any other heart disease that could justify the severity of cardiac dysfunction; Major surgery within 2 weeks prior to randomization, or unhealed operation wounds.
- Toxin abuse/exposure (Alcohol, amphetamines, cocaine, anthracyclines [e.g., doxycycline], trastuzumab, clozapine, chloroquine, carbon monoxide, cobalt, lead, mercury;
- Clinical suspicion or proven underlying active, chronic or recurrent bacterial, fungal or viral infections, including tuberculosis, or HIV infection or epatitis B virus (HBV) or hepatitis C virus (HCV) infection, Lyme disease, Chagas disease or any other bacterial/fungeal/protozoal disease possibly responsible for DCM;
- Endocrine, infiltrative (Cushing’s disease, acromegaly not clinically controlled hypo/hyperthyroidism, pheochromocytoma) or neuromuscular diseases (Dystrophinopathies [Duchenne/Becker muscular dystrophy/X-linked DCM], Limb-girdle muscular dystrophies, Facioscapulohumeral muscular dystrophy, Emery-Dreifuss muscular dystrophy, Friedreich’s ataxia, Myotonic dystrophy);
- Contraindications to EMB;
- Contraindications to PET/MRI (i.e. gadolinium hypersensitivity, renal failure, claustrophobia, pacemaker or ICD device, blood glucose>12.5 mmol/L);
- History of malignancy in the previous 5 years. Exceptions are basal cell skin cancer, carcinoma-in-situ of the cervix or low-risk prostate cancer after curative therapy;
- Any other concomitant or previous biological anti-cytokine treatment administered within 5 -half lives of the specific drug;
- Renal failure as defined by estimated glomerular filtration rate (eGFR) <30 ml/min, according to Cockcroft-Gault;
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.