RecruitingPhase 3NCT06158698

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

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


Sponsor

Niguarda Hospital

Enrollment

80 participants

Start Date

Nov 14, 2023

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial (CMP-MYTHiC) is testing whether colchicine — a medication commonly used for gout and inflammation — can help patients who have inflammatory heart muscle disease (myocarditis) leading to heart failure or dangerous heart rhythms. Researchers want to see if reducing inflammation in the heart improves outcomes. **You may be eligible if...** - You are 18 years or older - You have been diagnosed with inflammatory heart muscle disease (inflammatory cardiomyopathy) with confirmed inflammation on a cardiac MRI - You are experiencing abnormal heart rhythms, reduced heart pumping function, or elevated heart stress markers **You may NOT be eligible if...** - You do not have evidence of heart muscle inflammation on cardiac MRI - You are under 18 years old - You have conditions that make colchicine unsafe (such as severe kidney or liver disease) Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUGColchicine

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

OTHERPlacebo

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

View Full Details on ClinicalTrials.gov

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NCT06158698


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