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.

DECIPHERING IL-1 MEDIATED INFLAMMATION FOR THE TARGETED TREATMENT OF DILATED CARDIOMYOPATHY. - DICTAT-1

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-005507-39-IT

Enrollment

Registered

2021-06-04

Start date

2022-03-17

Completion date

Unknown

Last updated

2024-12-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Inflammatory dilated cardiomyopathy MedDRA version: 20.0 Level: LLT Classification code 10056419 Term: Dilated cardiomyopathy System Organ Class: 10007541 - Cardiac disorders MedDRA version: 20.0 Level: PT Classification code 10007636 Term: Cardiomyopathy System Organ Class: 10007541 - Cardiac disorders MedDRA version: 20.0 Level: HLGT Classification code 10019280 Term: Heart failures System Organ Class: 10007541 - Cardiac disorders

Interventions

Trade Name: KINERET - "100 MG/0,67 ML SOLUZIONE INIETTABILE" USO SOTTOCUTANEO SIRINGA PRERIEMPITA 7 SIRINGHE PRERIEMPITE Product Name: KINERET Product Code: [KINERET] Pharmaceutical Form: Solution for

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Age: 18 Years to 75 years; 2. Diagnosis of DCM according to current guidelines; 3. Symptoms of HF not improved or worsened despite at least 3 months of optimal therapy; 4. LVEF 50% at angiography or coronary CT Scan, acceptable if performed during the last 12 months). 7. Ability to sign an informed consent; 8. 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. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 18 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 6

Exclusion criteria

Exclusion criteria: 1. Genetic DCM; 2. Toxin abuse/exposure (Alcohol, amphetamines, cocaine, anthracyclines [e.g., doxycycline], trastuzumab, clozapine, chloroquine, carbon monoxide, cobalt, lead, mercury; 3. 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; 4. 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); 5. Contraindications to EMB; 6. Contraindications to PET/MRI (i.e. gadolinium hypersensitivity, renal failure, claustrophobia, pacemaker or ICD device, blood glucose>12.5 mmol/L); 7. 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; 8. Any other concomitant or previous biological anti-cytokine treatment administered within 5 -half lives of the specific drug; 9. Renal failure as defined by estimated glomerular filtration rate (eGFR) 10 mg daily and/or any immuno-suppressive agents within 3 months before the enrolment; 18. 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.

Design outcomes

Primary

Measure	Time frame
Main Objective: 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.;Secondary Objective: 1.To assess the efficacy of Anakinra in improving heart failure symptoms at 4 weeks (T1) and 12 weeks (T2). 2.To assess the ability of Anakinra in improving the Total Quality Adjusted Life Year (QALYs) and patients reported outcomes at T1,T2 3. To evaluate the efficacy of Anakinra in reducing venricular arrhythmias on 24h-ECG Holter at T1,T2 4.To evaluate the efficacy of Anakinra in improving LVEF assessed by TTE at T2 5.Changes in LV volumes and diameters on TTE at T1,T2 6.To evaluate the efficacy of Anakinra in decreasing i-DCM-related hospitalization at T2 7.To evaluate changes in NT-proBNP and high-sensitive troponin T serum levels at T1,T2 8.To evaluate changes in C-reactive proteine (CRP), erythrocyte sedimentation rate (ESR), IL-1a, IL1RA, IL-1b, IL-6 and IL-18 serum levels at T1,T2 9.To evaluate the safety of anakinra in the treatment of i-DCM at 4 different time points: baseline,T1, T2, and last follow-up (T3).;Primary end point(s): Improvement in left-ventricular function, based on the increase of left ventricular (LV) ejection fraction (EF) assessed by transthoracic echocardiography at 4-weeks.;Timepoint(s) of evaluation of this end point: 4 weeks	—

Measure

Time frame

Main Objective: 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.;Secondary Objective: 1.To assess the efficacy of Anakinra in improving heart failure symptoms at 4 weeks (T1) and 12 weeks (T2). 2.To assess the ability of Anakinra in improving the Total Quality Adjusted Life Year (QALYs) and patients reported outcomes at T1,T2 3. To evaluate the efficacy of Anakinra in reducing venricular arrhythmias on 24h-ECG Holter at T1,T2 4.To evaluate the efficacy of Anakinra in improving LVEF assessed by TTE at T2 5.Changes in LV volumes and diameters on TTE at T1,T2 6.To evaluate the efficacy of Anakinra in decreasing i-DCM-related hospitalization at T2 7.To evaluate changes in NT-proBNP and high-sensitive troponin T serum levels at T1,T2 8.To evaluate changes in C-reactive proteine (CRP), erythrocyte sedimentation rate (ESR), IL-1a, IL1RA, IL-1b, IL-6 and IL-18 serum levels at T1,T2 9.To evaluate the safety of anakinra in the treatment of i-DCM at 4 different time points: baseline,T1, T2, and last follow-up (T3).;Primary end point(s): Improvement in left-ventricular function, based on the increase of left ventricular (LV) ejection fraction (EF) assessed by transthoracic echocardiography at 4-weeks.;Timepoint(s) of evaluation of this end point: 4 weeks

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Secondary

Measure	Time frame
Secondary end point(s): To evaluate the efficacy of Anakinra in improving LVEF assessed by Trans Thoracic Echocardiograhy (TTE) at 12 weeks (T2).; Changes in LV volumes and diameters on TTE at 4 weeks (T1) and 12 weeks (T2).; 1. To evaluate the efficacy of Anakinra in decreasing i-DCM-related hospitalization at 12 weeks (T2), by evaluating the number of days alive free of any DCM-related hospitalization at T2.; To evaluate changes in NT-proBNP serum levels at 4 weeks (T1) and 12 weeks (T2).; To evaluate changes in the high-sensitive troponin T serum levels at 4 weeks (T1) and 12 weeks (T2).; To evaluate changes in C-reactive proteine (CRP), erythrocyte sedimentation rate (ESR), IL-1alpha, IL1RA, IL-1beta, IL-6 and IL-18 serum levels at at 4 weeks (T1) and 12 weeks (T2).; To evaluate the safety of anakinra in the treatment of i-DCM at 4 different time points: baseline, 4 weeks (T1), 12 weeks (T2), and last follow-up (T3).; 1. To assess the efficacy of Anakinra in improving heart failure symptoms [New York Heart Association (NYHA) class] at 2 different time points: 4 weeks (T1) and 12 weeks (T2).; To assess the ability of Anakinra in improving the Total Quality Adjusted Life Year (QALYs) and patients reported outcomes (PROs) evaluated by Minnesota Living with SF36, Heart Failure and Kansas City Cardiomiopathy questionnaires at 4 weeks (T1) and 12 weeks (T2).; To evaluate the efficacy of Anakinra in reducing venricular arrhythmias (number of ventricular ectopic beats, runs of ventricular tachycardia) on 24h-ECG Holter at 4 weeks (T1) and 12 weeks (T2).;Timepoint(s) of evaluation of this end point: 12 weeks; 4 weeks and 12 weeks; 12 weeks; 4 weeks and 12 weeks; 4 weeks and 12 weeks; 4 weeks and 12 weeks; baseline, 4 weeks, 12 weeks and last follow-up; 4 weeks and 12 weeks; 4 weeks and 12 weeks; 4 weeks and 12 weeks	—

Measure

Time frame

Secondary end point(s): To evaluate the efficacy of Anakinra in improving LVEF assessed by Trans Thoracic Echocardiograhy (TTE) at 12 weeks (T2).; Changes in LV volumes and diameters on TTE at 4 weeks (T1) and 12 weeks (T2).; 1. To evaluate the efficacy of Anakinra in decreasing i-DCM-related hospitalization at 12 weeks (T2), by evaluating the number of days alive free of any DCM-related hospitalization at T2.; To evaluate changes in NT-proBNP serum levels at 4 weeks (T1) and 12 weeks (T2).; To evaluate changes in the high-sensitive troponin T serum levels at 4 weeks (T1) and 12 weeks (T2).; To evaluate changes in C-reactive proteine (CRP), erythrocyte sedimentation rate (ESR), IL-1alpha, IL1RA, IL-1beta, IL-6 and IL-18 serum levels at at 4 weeks (T1) and 12 weeks (T2).; To evaluate the safety of anakinra in the treatment of i-DCM at 4 different time points: baseline, 4 weeks (T1), 12 weeks (T2), and last follow-up (T3).; 1. To assess the efficacy of Anakinra in improving heart failure symptoms [New York Heart Association (NYHA) class] at 2 different time points: 4 weeks (T1) and 12 weeks (T2).; To assess the ability of Anakinra in improving the Total Quality Adjusted Life Year (QALYs) and patients reported outcomes (PROs) evaluated by Minnesota Living with SF36, Heart Failure and Kansas City Cardiomiopathy questionnaires at 4 weeks (T1) and 12 weeks (T2).; To evaluate the efficacy of Anakinra in reducing venricular arrhythmias (number of ventricular ectopic beats, runs of ventricular tachycardia) on 24h-ECG Holter at 4 weeks (T1) and 12 weeks (T2).;Timepoint(s) of evaluation of this end point: 12 weeks; 4 weeks and 12 weeks; 12 weeks; 4 weeks and 12 weeks; 4 weeks and 12 weeks; 4 weeks and 12 weeks; baseline, 4 weeks, 12 weeks and last follow-up; 4 weeks and 12 weeks; 4 weeks and 12 weeks; 4 weeks and 12 weeks

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Countries

Italy

Contacts

Public ContactUNITA' di IMMUNOLOGIA, REUMATOLOGIA

OSPEDALE SAN RAFFAELE

deluca.giacomo@hsr.it0226435157

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026