CMP-MYTHiC Trial and Registry - CardioMyoPathy With MYocarditis THerapy With Colchicine
Two-parallel groups randomized, single-blinded, multi-center phase III controlled trial in patients with chronic inflammatory cardiomyopathy to assess the efficacy of colchicine and associated prospective registry to assess the prognostic value of positive genetic testing in this population.
| Condition(s) | Cardiomyopathies, Myocarditis, Inflammatory Cardiomyopathy, Heart Failure, Ventricular Arrythmia |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | Two-parallel groups randomized, single-blinded, multi-center phase III controlled trial in patients with chronic inflammatory cardiomyopathy to assess the efficacy of colchicine and associated prospective registry to assess the prognostic value of positive genetic testing in this population. |
| Who can participate | Inclusion Criteria Trial and Registry: * Males and females with Infl-CMP associated with VA (including high PVC burden), reduced LVEF, or significantly increased levels of natriuretic peptides. * Patients of 18 years or older * 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. * Presence of any of the following characteristics and if symptoms have been present for more than 1 month: * Mono-morphic or polymorphic PVC burden of ≥3000 in 24 hours, or NSVTs (defined as \>3 more consecutive beat lasting \<30 seconds) or evidence of sustained ventricular tachycardias (SVT). * Reduced LVEF on echocardiogram (\<50%) or on CMRI (\<60%)-. |
| Ages | 18 Years |
| Sex | All |
| Lead sponsor | Niguarda Hospital |
| Locations | Naples, Campania, Italy; Bologna, Emilia-Romagna, Italy; Trieste, Friuli Venezia Giulia, Italy; Udine, Friuli Venezia Giulia, Italy; Rome, Lazio, Italy; Milan, Lombardy, Italy (+4 more sites) |
| Start date | 2023-11-14 |
| NCT ID | NCT06158698 |
| Official listing | https://clinicaltrials.gov/study/NCT06158698 |