Actively Recruiting
CMP-MYTHiC Trial and Registry - CardioMyoPathy With MYocarditis THerapy With Colchicine
Led by Niguarda Hospital · Updated on 2026-04-20
80
Participants Needed
10
Research Sites
233 weeks
Total Duration
On this page
Sponsors
N
Niguarda Hospital
Lead Sponsor
E
European Union
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
CMP-MYTHiC Trial and Registry - CardioMyoPathy With MYocarditis THerapy With Colchicine
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female patients with chronic inflammatory cardiomyopathy associated with ventricular arrhythmias, reduced left ventricular ejection fraction, or high levels of natriuretic peptides
- Age 18 years or older
- Evidence of myocardial inflammation on cardiac MRI (2018 Lake Louise criteria) or FDG-PET scan within 3 months before randomization for trial inclusion, or within 12 months for registry inclusion
- Presence of one or more of the following symptoms lasting more than 1 month: monomorphic or polymorphic premature ventricular complexes (≥3000 in 24 hours), non-sustained ventricular tachycardias, sustained ventricular tachycardias
- Reduced left ventricular ejection fraction (<50% on echocardiogram or <60% on cardiac MRI) or elevated NT-proBNP ≥1000 pg/mL or BNP ≥200 pg/mL
- Persistent elevated high-sensitivity troponin above the upper reference limit for at least 2 months and a premature ventricular complex burden ≥1000 in 24 hours
You will not qualify if you...
- History of myocardial infarction with ischemic scar on echocardiogram or cardiac MRI
- Significant coronary artery disease with stenosis above 50% on invasive or CT coronary angiography
- Cardiomyopathy caused by toxins (alcohol, illicit drugs) or specific diseases like amyloidosis or hypertrophic cardiomyopathy
- Known systemic autoimmune disorders, except certain cases with family history of cardiomyopathy or myocarditis as specified
- Previous cardiac surgery such as congenital heart disease correction or valve repair/replacement
- Chronic infectious diseases like HIV or tuberculosis
- Participation in another clinical trial involving investigational drugs within 30 days before screening
- Any disease or condition expected to reduce life expectancy below 12 months or hinder trial participation
- Women of childbearing potential (due to unknown colchicine risks to embryo/fetus)
- Current symptomatic atrial arrhythmias with left ventricular dysfunction
- Advanced heart failure (NYHA class III or need for inotropic support) or recurrent ventricular arrhythmias despite ablation
- Use of chronic immunosuppressive therapies or conditions requiring immunosuppression at randomization
- Allergy or contraindication to colchicine or its ingredients
- Severe kidney impairment (eGFR <30 ml/min/1.73m2)
- History of liver cirrhosis or baseline transaminase levels more than three times the upper limit
- Peripheral eosinophilia over 10% or known hypereosinophilic syndrome
- Severe gastrointestinal problems such as malabsorption or chronic diarrhea
- Women who are breastfeeding
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 10 locations
1
Università degli studi della Campania L.Vanvitelli e Azienda Ospedaliera Specialistica dei Colli - Ospedale Monaldi
Naples, Campania, Italy, 80131
Actively Recruiting
2
Policlinico S.Orsola-Malpighi
Bologna, Emilia-Romagna, Italy, 40138
Actively Recruiting
3
Azienda Sanitaria Universitaria Integrata Giuliano Isontina, Trieste
Trieste, Friuli Venezia Giulia, Italy, 34128
Actively Recruiting
4
Presidio Ospedaliero Universitario "Santa Maria della Misericordia"
Udine, Friuli Venezia Giulia, Italy, 33100
Actively Recruiting
5
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Rome, Lazio, Italy, 800168
Actively Recruiting
6
IRCCS Ospedale San Raffaele
Milan, Lombardy, Italy, 20132
Actively Recruiting
7
ASST Grande Ospedale Metropolitano Niguarda
Milan, Lombardy, Italy, 20169
Actively Recruiting
8
Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino
Turin, Piedmont, Italy, 10126
Actively Recruiting
9
Università Politecnica delle Marche e AOU Ospedali Riuniti Umberto I°-Lancisi-Salesi , Ancona
Ancona, The Marches, Italy, 60126
Actively Recruiting
10
ASL8 Arezzo San Donato Hospital
Arezzo, Tuscany, Italy, 52100
Actively Recruiting
Research Team
E
Enrico Ammirati, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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