CMP-MYTHiC Trial and Registry - CardioMyoPathy With MYocarditis THerapy With Colchicine

Recruiting Phase 3 Interventional Study
Cardiomyopathies Myocarditis Inflammatory Cardiomyopathy Heart Failure Ventricular Arrythmia
Pivotal Trial This treatment is in the last trial phase before FDA approval. Prior Safety Data This treatment has already been tested in at least one earlier human trial.
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At a Glance
Age
18 and older
Sex
Any
Trial phase
Phase 3
Study type
Interventional
Purpose
Treatment
Participants needed
80 (estimated)
Sponsor
Niguarda Hospital · Other
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About This Trial

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.

Trial Locations
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Eligibility Criteria
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 crit…
Contacts

Enrico Ammirati, MD, PhD

0264447791

enrico.ammirati@ospedaleniguarda.it

CONTACT