Management of Acute Myocarditis and Chronic Inflammatory Cardiomyopathy: An Expert Consensus Document.
Enrico Ammirati, Maria Frigerio, Eric D Adler...
https://pubmed.ncbi.nlm.nih.gov/33176455Actively Recruiting
Phase 3
Age: 18Years +
All Genders
ID06158698
Single-blinded Randomized Controlled Trial to Assess Colchicine for Cardiomyopathy with Myocarditis
Led by Niguarda Hospital · Updated on 2026-04-20
80
Participants Needed
10
Research Sites
104 weeks
Total Duration
On this page
Sponsors
N
Niguarda Hospital
Lead Sponsor
E
European Union
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating colchicine as a treatment for patients with chronic inflammatory cardiomyopathy (Infl-CMP), a heart condition caused by inflammation of the heart muscle that can lead to dangerous heart rhythm problems and heart failure. This phase III trial also includes a registry to study the role of genetic factors in the disease. The trial aims to find out if colchicine can reduce inflammation and improve heart function compared to placebo, especially considering patients' genetic backgrounds. In this randomized, single-blinded, multi-center trial, patients with Infl-CMP will receive colchicine at doses of 0.5 to 1 mg daily or placebo tablets for 6 months. The study includes patients with signs of heart inflammation confirmed by imaging tests like cardiac MRI or PET scans, along with specific heart rhythm abnormalities or reduced heart pumping ability. A prospective registry will follow additional patients to explore the impact of genetic testing on disease outcomes. Blood and tissue samples will also be studied to understand the underlying molecular mechanisms. Participants will undergo regular assessments over the 6-month treatment period, including imaging tests, heart rhythm monitoring, blood tests, and evaluations of symptoms and quality of life. Researchers will measure whether patients remain alive without disease worsening and look for improvements in heart imaging or arrhythmia burden. Safety monitoring and follow-up will continue through the trial, with results aimed at guiding future personalized treatments for Infl-CMP.
CONDITIONS
Brief Title
CMP-MYTHiC Trial and Registry - CardioMyoPathy With MYocarditis THerapy With Colchicine
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Adults aged 18 years or older
- Males and females with chronic inflammatory cardiomyopathy linked to ventricular arrhythmia or heart failure
- Evidence of heart inflammation on cardiac MRI or FDG-PET scan within 3 months before randomization for trial inclusion, or within 12 months for registry inclusion
- Symptoms present for more than 1 month with either high premature ventricular complex burden, sustained or non-sustained ventricular tachycardias, reduced left ventricular ejection fraction, or elevated natriuretic peptides
- Persistent elevated troponin levels and significant premature ventricular complex burden after at least 2 months from first assessment
You will not qualify if you...
- History of myocardial infarction with ischemic scar on imaging
- Significant coronary artery disease with stenosis above 50%
- Cardiomyopathy caused by toxins, amyloidosis, or hypertrophic cardiomyopathy
- Known systemic autoimmune disorders, except certain cases with family history and genetic overlap
- Previous cardiac surgery such as congenital heart correction or valve repair/replacement
- Chronic infections like HIV or tuberculosis
- Participation in another clinical trial with investigational drug within 30 days prior to screening
- Life expectancy less than 12 months due to other diseases
- Women who are breastfeeding or of childbearing potential
- Current symptomatic atrial arrhythmias associated with left ventricular dysfunction
- Advanced heart failure (NYHA III) or recurrent ventricular arrhythmias despite prior catheter ablation
- Need for immunosuppressive therapy or current use of colchicine
- Allergies or contraindications to colchicine
- Severe kidney impairment (eGFR below 30 ml/min/1.73m2)
- Liver cirrhosis or elevated liver enzymes more than three times normal
- Peripheral eosinophilia or hypereosinophilic syndrome
- Severe gastrointestinal disorders such as malabsorption or chronic diarrhea
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 6 months
Participants receive either colchicine or placebo daily to assess the effect on inflammatory cardiomyopathy symptoms and heart function.
Regular visits during treatment to monitor response and safety
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
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Research Team
E
Enrico Ammirati, MD, PhD
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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Published Research Related To This Trial
Acute Myocarditis Associated With Desmosomal Gene Variants.
Enrico Ammirati, Francesca Raimondi, Nicolas Piriou...
https://pubmed.ncbi.nlm.nih.gov/36175056Lymphocytic Myocarditis: A Genetically Predisposed Disease?
Jessica Artico, Marco Merlo, Giulia Delcaro...
https://pubmed.ncbi.nlm.nih.gov/32553263Diagnosis and Treatment of Acute Myocarditis: A Review.
Enrico Ammirati, Javid J Moslehi
https://pubmed.ncbi.nlm.nih.gov/37014337Myopathic Cardiac Genotypes Increase Risk for Myocarditis.
Amy R Kontorovich, Nihir Patel, Arden Moscati...
https://pubmed.ncbi.nlm.nih.gov/34368507Genetic Architecture of Acute Myocarditis and the Overlap With Inherited Cardiomyopathy.
Amrit S Lota, Mark R Hazebroek, Pantazis Theotokis...
https://pubmed.ncbi.nlm.nih.gov/36154167Myocarditis Causing Premature Ventricular Contractions: Insights From the MAVERIC Registry.
Dhanunjaya Lakkireddy, Mohit K Turagam, Bharath Yarlagadda...
https://pubmed.ncbi.nlm.nih.gov/31838913Efficacy and Safety of Low-Dose Colchicine after Myocardial Infarction.
Jean-Claude Tardif, Simon Kouz, David D Waters...
https://pubmed.ncbi.nlm.nih.gov/31733140Drug-screening platform based on the contractility of tissue-engineered muscle.
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https://pubmed.ncbi.nlm.nih.gov/18236465Automated analysis of contractile force and Ca2+ transients in engineered heart tissue.
Andrea Stoehr, Christiane Neuber, Christina Baldauf...
https://pubmed.ncbi.nlm.nih.gov/24585781