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RECRUITING
NCT06158698
PHASE3

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

Sponsor: Niguarda Hospital

View on ClinicalTrials.gov

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.

Official title: Single-blinded Randomized Investigator-initiated Controlled Trial to Assess the Efficacy of Colchicine to Treat Patients With Cardiomyopathy With Myocarditis (Chronic Inflammatory Cardiomyopathy)

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

80

Start Date

2023-11-14

Completion Date

2028-05-02

Last Updated

2024-12-13

Healthy Volunteers

No

Interventions

DRUG

Colchicine

Colchicine 1 mg daily (or 0.5 mg daily il weight \<70 kg) from randomization for 180 days (6 months)

OTHER

Placebo

Placebo 1 mg daily (or 0.5 mg daily il weight \<70 kg) from randomization for 180 days (6 months)

Locations (10)

Università degli studi della Campania L.Vanvitelli e Azienda Ospedaliera Specialistica dei Colli - Ospedale Monaldi

Naples, Campania, Italy

Policlinico S.Orsola-Malpighi

Bologna, Emilia-Romagna, Italy

Azienda Sanitaria Universitaria Integrata Giuliano Isontina, Trieste

Trieste, Friuli Venezia Giulia, Italy

Presidio Ospedaliero Universitario "Santa Maria della Misericordia"

Udine, Friuli Venezia Giulia, Italy

Fondazione Policlinico Universitario Agostino Gemelli IRCCS

Rome, Lazio, Italy

IRCCS Ospedale San Raffaele

Milan, Lombardy, Italy

ASST Grande Ospedale Metropolitano Niguarda

Milan, Lombardy, Italy

Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino

Turin, Piedmont, Italy

Università Politecnica delle Marche e AOU Ospedali Riuniti Umberto I°-Lancisi-Salesi , Ancona

Ancona, The Marches, Italy

ASL8 Arezzo San Donato Hospital

Arezzo, Tuscany, Italy