Cardiomyopathy with myocarditis (chronic inflammatory cardiomyopathy) MedDRA version: 20.0 Level: PT Classification code 10007636 Term: Cardiomyopathy System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Trade Name: COLCHICINA LIRCA - 1 MG COMPRESSE 60 COMPRESSE
Product Name: COLCHICINA
Product Code: [8884]
Pharmaceutical Form: Tablet
INN or Proposed INN: colchicina
CAS Number: 64-86-8
Current Sponsor
Sponsors
AZIENDA OSPEDALIERA AO OSPEDALE NIGUARDA CA' GRANDA
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Patients of 18 years or older 2. Evidence of myocardial inflammation on CMRI (using 2018 Lake Louis criteria) or FDG-PET performed in the 3 months before randomization to be included in the trial OR in the last 12 months before for the registry. 3. Presence of any of the following characteristics and if symptoms are present lasting for more than 1 month: a. Mono-morphic or polymorphic PVC burden of =3000 in 24 hours, or NSVTs (defined as >3 more consecutive beat lasting =65 years) yes F.1.3.1 Number of subjects for this age range 40
Exclusion criteria
Exclusion criteria: 1.Proven history of myocardial infarction with evidence of ischemic scar on echocardiogram or CMRI, 2. Significant flow-limiting coronary artery disease (stenosis above 50%) on invasive coronary angiography or computed tomography (CT) coronary angiography, 3. Cardiomyopathy attributed to toxins such as alcohol and illicit drugs, or to specific causes (i.e. amyloidosis or hypertrophic cardiomyopathy) 4. Known systemic autoimmune disorder (the exception will be for patients with systemic autoimmune disease or isolated cardiac sarcoidosis with a family history of cardiomyopathy, myocarditis, or arrhythmias, where overlap between an autoimmune event and a genetic background can occur). These patients will undergo genetic tests. Patients with autoimmune systemic disorders and isolated cardiac sarcoidosis with positive genetic tests for MCVG will be included in the registry. 5. Previous history of cardiac surgery for instance correction of congenital heart disease or a valve repair/replacement 6. Known chronic infective disease, such as HIV infection or tuberculosis 7. Participants involved in another clinical trial; 8. Pregnant women (known pregnancy) or POSITIVE human chorionic gonadotropin (HCG) test measures (urine/blood) for women of 18-50 years of age; and breastfeeding women. 9. Any other significant disease or disorder which (expected life expectancy x3-fold the URL 17.Patients with peripheral eosinophilia (eosinophil count >10% of the leukocytes) or known hypereosinophilic syndrome at the time of randomization.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary efficacy will be measured after 6 months of treatment (colchicine vs. placebo). It is expected that patients on optimal medical therapy (OMT) plus colchicine will have a large proportion of positive responses.;Secondary Objective: 1.Improvement in left ventricular (LV) ejection fraction (EF) on echocardiogram. Patients not performing the CMRI due to death, heart transplantation (HTx) will be counted as -10 point in the LVEF. 2.Improvement in LVEF on CMRI when available. 3.Lower % of patients with LVEF5% ) on 24-hour ECG ambulatory monitoring, performed at 6- months 8.Changes from baseline to 6 months in quality of life and health assessment 9.Need to initiate an immunosuppressive drug (i.e. corticosteroids);Primary end point(s): Larger proportion of positive response to treatment will include survival free of clinical worsening, worsening arrhythmic burden, and imaging outcome PLUS ANY of the signs of improvements (IMAGING or ARRHYTMIC improvements).;Timepoint(s) of evaluation of this end point: At 6 months follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Improvement in left ventricular (LV) ejection fraction (EF) on echocardiogram. Patients not performing the CMRI due to death, heart transplantation (HTx) will be counted as -10 point in the LVEF. 2. Improvement in LVEF on CMRI when available. Patients not performing the CMRI due to death, heart transplantation (HTx), LV assist device (LVAD) implantation or device implantation after randomization (i.e. pacemaker [PM] or implantable cardioverter defibrillator [ICD]) will be counted as -10 point in the LVEF. 3. Lower proportion of patients with LVEF5% ) on 24-hour ECG ambulatory monitoring, performed at 6- months 8. Changes in quality of life and health assessment at 6 months follow up compared with baseline using 2 different questionnaires: the EuroQoL 5-dimension, 5-level questionnaire (EoQ-5D) and Kansas City Cardiomyopathy Questionnaire (KCCQ – clinical summary scale and overall summary scale). 9. Need to initiate an immunosuppressive drug (i.e. corticosteroids);Timepoint(s) of evaluation of this end point: At 6 months follow-up | — |
Countries
Italy
Contacts
Public ContactCardiologia 2 - Insuff.Card e Trap.
ASST GRANDE OSPEDALE METROPOLITANO NIGUARDA
Outcome results
None listed