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RecruitingNCT06158698CMP-MYTHiCUpdated Apr 20, 2026

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

A Phase 3 interventional study of Colchicine and Placebo in Cardiomyopathies, Myocarditis and Inflammatory Cardiomyopathy, sponsored by Niguarda Hospital. Recruiting at 10 sites in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-04-20.

Primary conditionMyocarditisRegistry: CardiomyopathiesReclassifiedWhy we changed it
Registry
Cardiomyopathies — the first condition term the registry derived for this study.
ClinicalTrials.gg
Myocarditis
Why
  1. The study's listed conditions name Myocarditis, a narrower term within Cardiomyopathies.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Niguarda Hospital · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Primary completion was expected by May 2026, 6 months ago, but the record still lists the study as recruiting.
  • Started Nov 2023; still recruiting 2 years 11 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
80
Allocation
Randomized
Ages
18 Years and older
Sex
All
01

Study 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.

Read the detailed description

In a proportion of patients, myocarditis, an inflammatory injury of cardiomyocytes (CMs), can lead to chronic inflammatory cardiomyopathy (Infl-CMP) characterized by an increased risk of life-threatening ventricular arrhythmias (VA) or ventricular dysfunction and heart failure (HF). Most cases of myocarditis have a viral trigger or an autoimmune etiology, while genetic predisposition has been sporadically reported. Recent data point to a relevant role of genetics, with pathogenic genetic variants associated with dilated or arrhythmic cardiomyopathies found in 8-31% of patients with Infl-CMP and left ventricular (LV) systolic dysfunction. Occasionally, patients with myocarditis may have a positive family history of cardiomyopathy, or sudden cardiac death (SCD), which can lead to genetic testing for myopathic cardiac gene variants (MCGV). Small series showed the co-existence of myocarditis and MCGV in patients with dilated cardiomyopathy. In this complex background, it is still unclear whether targeting myocardial inflammation with immunomodulating drugs can ameliorate the outcome of these patients.

TRIAL - The Investigators will conduct a Trial to assess whether in patients with Infl-CMP with VA or HF phenotype, colchicine compared with placebo can reduce myocardial inflammation improving the clinical condition of patients. In the trial both patients with positive MCGV and negative MCGV will be randomized, and the investigators check if the genetic background can affect the response to colchicine. The target of this pilot trial is to randomize 40 patients in each arm and have ideally 15 patients with MCGV(+) in each arm. The use of colchicine in our proposal of trial relies on the safety of colchicine, and the relatively low rate of side effects at low dosages. It has shown that colchicine performs its functions by inhibiting the activation of pore formation carried out by P2X2 and P2X7 receptors, that concur to the activation of the inflammasome, thus potentially targeting a specific cause observed in Infl-CMP.

In a pilot, randomized, and single-blinded trial the investigators look at the immunomodulating effect of colchicine 0.5-1 mg vs. placebo in patients with Infl-CMP based on cardiac magnetic resonance imaging (CMRI) or fluorodeoxyglucose (FGD)-positron emission tomography (PET) scan with VA (including high premature ventricular complexes [PVC] burden), reduced LV ejection fraction (EF), or significantly increased levels of natriuretic peptides but without indication to immunosuppression (i.e., associated systemic autoimmune disorders) to assess whether colchicine can improve myocardial inflammation or decrease troponin release or the burden of PVCs or improve the clinical outcome (major VA, HF hospitalizations). The duration of the trial will be 6 months. The rationale of the pilot (CMP-MYTHiC CardioMyoPathy with MYocarditis THerapy with Colchicine) trial is based on a recent registry of 55 symptomatic patients with >5000 premature ventricular complexes (PVCs)/24 hours with FDG-PET imaging consistent with Infl-CMP, where a signal of benefit was observed in patients who received prednisone 40 mg for 3 months. The benefit was defined as a reduction in the PVC burden >80% and negative FDG-PET scan at follow-up. It must be noted that up to 24% of these cases had a diagnosis of sarcoidosis, where there is already an indication to therapy with steroids. In this study (MAVERIC registry) the improvement of patients treated with prednisone alone was 84% vs. 33% in patients not taking prednisone. As the investigators expect a lower effect of colchicine compared with prednisone but with a safer drug profile than prednisone, the investigators considered a theoretical optimal response in patients taking colchicine of 66%, while the investigators expected a similar optimal response in patients taking placebo as in the MAVERIC registry in patients not taking prednisone. Thus, considering an increase in the probability to reach the primary endpoint, defined as proportion of patients that are alive and free of any worsening (clinical, arrhythmic burden and imaging outcome) and that shows at least one of the signs of improvements (IMAGING or ARRHYTMIC improvements) at 6 months from 33% in the placebo arm to 66% in the colchicine therapy arm, the planned sample size of 80 patients (40 per group) will allow achieving a power of 0.80 with an overall type I error of 0.025 using one-sided Fisher's Exact test.

Endpoints will be analyzed according to the following principles:

  1. Intention-to-treat (ITT) population: patients according to assigned randomized treatment arm.
  2. Per Protocol (PP) population: only patients allocated to the colchicine therapy arm who took the drug for at least 4 months will be considered in the experimental group. Patients assigned to the colchicine therapy arm that will receive less than 4-month colchicine therapy will be excluded from this population. Likely, patients allocated to the optimal medical therapy with placebo will be included if they have taken the placebo therapy for at least 4 months. Patients allocated to the treatment or placebo that will receive any immunosuppressive agents (e.g. corticosteroids) for at least 1 month during the trial will be excluded from this population.
  3. A sensitivity analysis will also be performed on the previously defined populations after excluding patients (1) with an implantable cardioverter defibrillator (ICD) before randomization (2) who underwent a ventricular ablation before randomization (3) who were diagnosed with a systemic autoimmune disorder or a histological diagnosis of eosinophilic myocarditis, cardiac sarcoidosis or giant cell myocarditis after the randomization.

REGISTRY - The main aim is to determine if patients with positive MCGV (+) Infl-CMP have a worse outcome compared with patients with negative MCGV (-) Infl-CMP in terms of recurrence of VA, including a high burden of PVCs or HF episodes or reduced improvement of ventricular function or persistence of myocardial inflammation on follow-up CMRI or FDG-PET. Furthermore, the investigators investigated characteristics that can help to identify patients with likely positive genetic tests among patients presenting with Infl-CMP, and variables that are independently associated with prognosis in patients with Infl-CMP. If patients have criteria to enter the registry, but not the trial, or (2) if do not consent to be randomized while they are willing to be followed in the registry, or (3) if the number of 80 patients is reached in the trial, even if the patients have the criteria to be included in the trial, these patients will enter the prospective registry. The foreseen number of the patients in the registry is 50-70 during the study period. To reach the objectives of the registry, deep phenotypical characterization of patients presenting with chronic Infl-CMP with VA and HF phenotypes will be performed in association with genetic testing.

TRANSLATIONAL STUDY - the investigators will perform translational experiments from the blood sample and endomyocardial biopsy (EMB) from patients recruited in the trial and the registry, if they consent. In particular, 50 patients (the first 25 with positive genetics and 25 with negative genetics) who agree to donate 18 mL of their blood will enter the translational study. From the blood, the investigators will get human-induced pluripotent stem cells (iPSC-CM) to unveil the molecular mechanisms that are responsible for the inflammatory response in the myocardium. As a control group, the investigators will involve the first 25 family members of the probands with the negative cardiac phenotype (FMPNCP) test that agree to be sampled for the same amount of blood. The hypothesis of these experiments is that a specific genetic background identified in patients with Inf-CMP is sufficient to induce an inflammatory myocardial response. Briefly, the investigators will generate tridimensional cardiac tissues (EHTs) using CMs derived from human-iPSC-CM from patients with MCGV(+) Infl-CMP versus MCGV(-) Infl- CMP and FMPNCP. EHTs and CMs will be subjected to specific mechanical, cellular, and pharmacological stimuli to unveil the molecular mechanisms that are responsible for the inflammatory response. The results of these experiments, together with the molecular analysis of EMBs could reveal novel molecular pathways that will be relevant to specific personalized therapeutic approaches.

02

Conditions studied

  • Cardiomyopathies
  • Myocarditis
  • Inflammatory Cardiomyopathy
  • Heart Failure
  • Ventricular Arrythmia

Browse trials for

Keywords

  • treatment
  • trial
  • colchicine
  • registry
  • inflammation
  • outcome
  • genetic testing
03

In context

Myocarditis Reclassified

174 studies on the registry are indexed under Myocarditis; 75 are open to participants now.

This study's planned enrollment of 80 is close to the median of 80 across 53 interventional studies indexed under Myocarditis.

Browse Myocarditis studies →

Lead sponsor

Niguarda Hospital is the lead sponsor of 68 studies on the registry; 29 are open to participants now.

Compared within Myocarditis, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Cardiomyopathies. The counts are of registry records indexed under each term, refreshed daily. How we classify →

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Eligibility criteria

Inclusion Criteria Trial and Registry:

  • Males and females with Infl-CMP associated with VA (including high PVC burden), reduced , or significantly increased levels of natriuretic peptides.
  • Patients of 18 years or older
  • Evidence of myocardial inflammation on CMRI (using 2018 Lake Louis criteria) or FDG-PET performed in the 3 months before randomization to be included in the trial OR in the last 12 months before for the registry.
  • Presence of any of the following characteristics and if symptoms have been present for more than 1 month:
  • Mono-morphic or polymorphic PVC burden of ≥3000 in 24 hours, or NSVTs (defined as >3 more consecutive beat lasting \<30 seconds) or evidence of sustained ventricular tachycardias (SVT).
  • Reduced LVEF on echocardiogram (\<50%) or on CMRI (\<60%)-. Increased N-terminal pro-B-type natriuretic peptide (NT- proBNP) concentration of 1000 pg/mL or more, or a B-type natriuretic peptide (BNP) concentration of 200 pg/mL or more
  • Persistence of increased high-sensitivity troponin levels above the upper reference limit (URL) after at least 2 months from the first assessment and at least a mono-morphic or polymorphic PVC burden of ≥1000 in 24 hours.

Exclusion Criteria Registry:

  • Proven history of myocardial infarction with evidence of ischemic scar on echocardiogram or CMRI,
  • Significant flow-limiting coronary artery disease (stenosis above 50%) on invasive coronary angiography or computed tomography (CT) coronary angiography,
  • Cardiomyopathy attributed to toxins such as alcohol and illicit drugs, or to specific causes (i.e. amyloidosis or hypertrophic cardiomyopathy)
  • Known systemic disorder (the exception will be for patients with systemic autoimmune disease or isolated cardiac sarcoidosis with a family history of cardiomyopathy, myocarditis, or arrhythmias, where overlap between an autoimmune event and a genetic background can occur). These patients will undergo genetic tests. Patients with autoimmune systemic disorders and isolated cardiac sarcoidosis with positive genetic tests for MCVG will be included in the registry.
  • Previous history of cardiac surgery for instance correction of congenital heart disease or a valve repair/replacement
  • Known chronic infective disease, such as infection or tuberculosis
  • Participants involved in another clinical trial, defined by the participation in a clinical trial in which an drug was administered in the 30 days prior to screening, or 5 half-lives of the study drug, whichever is longer;
  • Any other significant disease or disorder which (expected \<12 months), in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial or the participant's ability to participate in the trial.

Exclusion Criteria Trial :

  • Proven history of myocardial infarction with evidence of ischemic scar on echocardiogram or CMRI,
  • Significant flow-limiting coronary artery disease (stenosis above 50%) on invasive coronary angiography or computed tomography (CT) coronary angiography,
  • Cardiomyopathy attributed to toxins such as alcohol and illicit drugs, or to specific causes (i.e. amyloidosis or hypertrophic cardiomyopathy)
  • Known systemic autoimmune disorder (the exception will be for patients with systemic autoimmune disease or isolated cardiac sarcoidosis with a family history of cardiomyopathy, myocarditis, or arrhythmias, where overlap between an autoimmune event and a genetic background can occur). These patients will undergo genetic tests. Patients with autoimmune systemic disorders and isolated cardiac sarcoidosis with positive genetic tests for MCVG will be included in the registry.
  • Previous history of cardiac surgery for instance correction of congenital heart disease or a valve repair/replacement
  • Known chronic infective disease, such as HIV infection or tuberculosis
  • Participants involved in another clinical trial, defined by the participation in a clinical trial in which an investigational drug was administered in the 30 days prior to screening, or 5 half-lives of the study drug, whichever is longer;
  • Any other significant disease or disorder which (expected life expectancy \<12 months), in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial or the participant's ability to participate in the trial.
  • Women with (this exclusion criterion is due to insufficient human information regarding the embryofoetal risk with colchicine)
  • Current symptomatic atrial arrhythmias (including persistent atrial fibrillation) associated with LV dysfunction,
  • Advance heart failure ( III or need for inotropes including levosimendan), or recurrent VA despite previous catheter ablation,
  • Known systemic autoimmune disorder or other conditions at the time of randomization where is assumed useful (i.e. cardiac sarcoidosis),
  • Patients already on chronic immunosuppressive therapies (including colchicine) or in whom immunosuppressive therapy is deemed necessary
  • to colchicine, including allergies to this medication and its (i.e., lactose and sucrose),
  • Impaired renal function (\<30 ml/min/1.73m2),
  • Known history of hepatic cirrhosis or transaminase levels at baseline > x3-fold the URL
  • Patients with peripheral eosinophilia (eosinophil count >10% of the leukocytes) or known hypereosinophilic syndrome at the time of randomization.
  • Severe gastrointestinal insufficiency (for instance, malabsorption syndrome, severe chronic diarrhea)
  • Women during breastfeeding
Terms in these criteria, in plain language(11)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

LVEF (left ventricular ejection fraction)

The share of blood the heart’s main pumping chamber (the left ventricle) pushes out with each beat, measured by an echocardiogram (heart ultrasound) or a MUGA scan. About 50–70% is normal.

Autoimmune disease

A condition in which the immune system attacks the body’s own tissues, such as rheumatoid arthritis, lupus, psoriasis, type 1 diabetes or inflammatory bowel disease.

Immunotherapy studies often leave out active autoimmune disease, and some name exceptions, such as thyroid disease on replacement hormone. Check the exceptions this study lists.

HIV

The human immunodeficiency virus, which weakens the immune system.

Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.

Investigational drug or device

A drug or device being studied in a clinical trial.

It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.

Life expectancy

The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.

Childbearing potential

Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).

Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.

NYHA class (heart failure)

The New York Heart Association’s four classes of how much heart failure limits physical activity.

I
No limits: ordinary activity causes no undue tiredness or breathlessness.
II
Slight limits: comfortable at rest, ordinary activity causes symptoms.
III
Marked limits: comfortable at rest, less than ordinary activity causes symptoms.
IV
Symptoms even at rest; any activity makes them worse.

Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.

Immunosuppression

A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.

Read whether the line is about a condition or about medicines, and which medicines and doses it means.

Contraindication

A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.

Excipients

The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.

GFR and eGFR (kidney filtering)

GFR (glomerular filtration rate) is how much blood the kidneys filter each minute. It is usually estimated from a blood test — eGFR, by formulas such as CKD-EPI or MDRD — and some studies ask for it to be measured directly instead. Usually given in mL/min/1.73 m².

Check the method, the units and the minimum the study states. A value of 90 or above is in the normal-or-high range, but kidney damage can show in other tests too.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Participant)
Enrollment
80 participants (estimated)

Study arms

  • Experimental
    Colchicine

    Patients treated with colchicine 0.5-1 mg (1 mg if tolerated) for 6 months.

    Drug: Colchicine

  • Placebo comparator
    Placebo

    Patients treated with placebo tablets.

    Other: Placebo

Interventions

  • DrugColchicine

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

    Also known as: Treatment

  • OtherPlacebo

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

06

What researchers measure

Primary outcomes

  1. Patients alive and free of any worsening features (clinical, arrhythmic burden and imaging outcome) AND that show at least one of the signs of improvements (IMAGING or ARRHYTMIC improvements).

    Clinical worsening (at least one of the following): 1. cardiac death 2. hospitalization for worsening HF or arrhythmic events, 3. Sustained ventricular tachycardia (SVT). Worsening arrhythmic burden: 1. PVC burden increase of 50% on ECG ambulatory monitoring 2. Increase in NSVT of 30% compared with baseline 3. Any SVT.

    Time frame: 6 months from randomization

  2. Worsening imaging outcomes

    1. Proportion of patients with LVEF reduction \>10%on echo/CMRI, 2. Proportion of patients with new areas of edema on CMRI or FDG-PET associated with an increase in the edema in the inflammatory lesion identified on baseline CMRI or FDG-PET. Improvement of imaging outcome: 1. Proportion of patients with a reduction in edema on CMRI or FDG without new areas of edema AND normal high sensitivity troponin. 2. Proportion of patients with disappearance of edema on CMRI OR NO FDG uptake on PET Improvement of arrhythmic outcome: 1\. Improvement of ARRHYTHMIC burden. Proportion of patients with a PVC burden reduction of 70% on the ECG ambulatory monitoring and no NSVT/SVT.

    Time frame: 6 months from randomization

Secondary outcomes

  1. LVEF change on echocardiogram.

    Absolute change at 6 months from randomization of the LVEF on echocardiogram. Patients not performing echocardiography due to death, heart transplantation (HTx) will be counted as -10 point in the LVEF.

    Time frame: 6 months from randomization

  2. LVEF change on CMRI

    Absolute change at 6 months from randomization of the LVEF on CMRI when available. Patients not performing the CMRI due to death, HTx, LVAD implantation or device implantation after randomization will be counted as -10 point in the LVEF.

    Time frame: 6 months from randomization

  3. Evidence of dysfunction and/or dilation on CMRI

    Proportion of patients with LVEF\<55% AND/OR LV dilation on 6-month CMRI (CMRI clips will be centrally reviewed) or not performing the CMRI due to death, HTx, LVAD implantation or device implantation after randomization (i.e. ICD).

    Time frame: 6 months from randomization

  4. Clinical secondary endpoints

    Composite endpoint: (1) all-cause death or (2) HTx or (3) LVAD implantation, or (5) first rehospitalization due to HF or VA, or advanced atrioventricular (AV) block.

    Time frame: 6 months from randomization

  5. Mortality

    All-cause deaths

    Time frame: 6 months from randomization

  6. Time to HF or arrhythmic events

    Time to hospitalization for HF/VA or advanced AV block

    Time frame: 6 months from randomization

  7. Changes on ambulatory ECG monitoring

    Composite endpoint of NSVT OR increased burden of PVCs (\>5%) on 24-hour ECG ambulatory monitoring, performed at 6- months

    Time frame: 6 months from randomization

  8. Changes in Quality of life

    Changes in quality of life at 6 months follow up compared with baseline using 2 different questionnaires: the EoQ-5D-5L and KCCQ (CSS and OSS)

    Time frame: 6 months from randomization

  9. Need for immunosuppression

    Need to initiate an immunosuppressive drug

    Time frame: 6 months from randomization

Other outcomes

  1. The primary aim of the REGISTRY is the proportion of patients with MCGV(+) Infl-CMP versus MCGV(-) Infl-CMP with more primary endpoints

    We will measure the outcome of the patients in the registry as described in the TRIAL at the end of a minimum follow-up of 6 months. The co-primary aim of the registry will be to the identify baseline variables that are independently associated with the above-mentioned 6-month endpoints. The patients who enter the registry are expected to follow an even longer follow-up of 2 The Registry endpoints pooling together patients included in the trial and registry.

    Time frame: Minimum follow up at 6 months

  2. Differences in the results of in-vitro experiments between MCGV(+) vs. MCGV(-) Infl-CMP patients and between MCGV(+) Infl-CMP patients and family members of the probands with the negative cardiac phenotype (FMPNCP)

    We will compare in-vitro experiments between MCGV(+) vs. Infl-CMP versus MCGV(-) Infl-CMP patients and between MCGV(+) Infl-CMP patients and family members of the probands with the negative cardiac phenotype (FMPNCP). Samples for the experiments will be from patients included in the trial and registry.

    Time frame: Minimum follow up at 6 months

07

Study locations

10 of 10 sites recruiting
  • Università degli studi della Campania L.Vanvitelli e Azienda Ospedaliera Specialistica dei Colli - Ospedale Monaldi
    Naples, Campania 80131, Italy
    Recruiting
  • Policlinico S.Orsola-Malpighi
    Bologna, Emilia-Romagna 40138, Italy
    Recruiting
  • Azienda Sanitaria Universitaria Integrata Giuliano Isontina, Trieste
    Trieste, Friuli Venezia Giulia 34128, Italy
    Recruiting
  • Presidio Ospedaliero Universitario "Santa Maria della Misericordia"
    Udine, Friuli Venezia Giulia 33100, Italy
    Recruiting
  • Fondazione Policlinico Universitario Agostino Gemelli IRCCS
    Rome, Lazio 800168, Italy
    Recruiting
  • IRCCS Ospedale San Raffaele
    Milan, Lombardy 20132, Italy
    Recruiting
  • ASST Grande Ospedale Metropolitano Niguarda
    Milan, Lombardy 20169, Italy
    Recruiting
  • Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino
    Turin, Piedmont 10126, Italy
    Recruiting
  • Università Politecnica delle Marche e AOU Ospedali Riuniti Umberto I°-Lancisi-Salesi , Ancona
    Ancona, The Marches 60126, Italy
    Recruiting
  • ASL8 Arezzo San Donato Hospital
    Arezzo, Tuscany 52100, Italy
    Recruiting
08

References and documents

Publications

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  • Ammirati E, Raimondi F, Piriou N, Sardo Infirri L, Mohiddin SA, Mazzanti A, Shenoy C, Cavallari UA, Imazio M, Aquaro GD, Olivotto I, Pedrotti P, Sekhri N, Van de Heyning CM, Broeckx G, Peretto G, Guttmann O, Dellegrottaglie S, Scatteia A, Gentile P, Merlo M, Goldberg RI, Reyentovich A, Sciamanna C, Klaassen S, Poller W, Trankle CR, Abbate A, Keren A, Horowitz-Cederboim S, Cadrin-Tourigny J, Tadros R, Annoni GA, Bonoldi E, Toquet C, Marteau L, Probst V, Trochu JN, Kissopoulou A, Grosu A, Kukavica D, Trancuccio A, Gil C, Tini G, Pedrazzini M, Torchio M, Sinagra G, Gimeno JR, Bernasconi D, Valsecchi MG, Klingel K, Adler ED, Camici PG, Cooper LT Jr. Acute Myocarditis Associated With Desmosomal Gene Variants. JACC Heart Fail. 2022 Oct;10(10):714-727. doi: 10.1016/j.jchf.2022.06.013. Epub 2022 Sep 7. PubMed 36175056 ↗
  • Artico J, Merlo M, Delcaro G, Cannata A, Gentile P, De Angelis G, Paldino A, Bussani R, Ferro MD, Sinagra G. Lymphocytic Myocarditis: A Genetically Predisposed Disease? J Am Coll Cardiol. 2020 Jun 23;75(24):3098-3100. doi: 10.1016/j.jacc.2020.04.048. No abstract available. PubMed 32553263 ↗
  • Ammirati E, Moslehi JJ. Diagnosis and Treatment of Acute Myocarditis: A Review. JAMA. 2023 Apr 4;329(13):1098-1113. doi: 10.1001/jama.2023.3371. PubMed 37014337 ↗
  • Kontorovich AR, Patel N, Moscati A, Richter F, Peter I, Purevjav E, Selejan SR, Kindermann I, Towbin JA, Bohm M, Klingel K, Gelb BD. Myopathic Cardiac Genotypes Increase Risk for Myocarditis. JACC Basic Transl Sci. 2021 Jul 26;6(7):584-592. doi: 10.1016/j.jacbts.2021.06.001. eCollection 2021 Jul. PubMed 34368507 ↗
  • Lota AS, Hazebroek MR, Theotokis P, Wassall R, Salmi S, Halliday BP, Tayal U, Verdonschot J, Meena D, Owen R, de Marvao A, Iacob A, Yazdani M, Hammersley DJ, Jones RE, Wage R, Buchan R, Vivian F, Hafouda Y, Noseda M, Gregson J, Mittal T, Wong J, Robertus JL, Baksi AJ, Vassiliou V, Tzoulaki I, Pantazis A, Cleland JGF, Barton PJR, Cook SA, Pennell DJ, Garcia-Pavia P, Cooper LT Jr, Heymans S, Ware JS, Prasad SK. Genetic Architecture of Acute Myocarditis and the Overlap With Inherited Cardiomyopathy. Circulation. 2022 Oct 11;146(15):1123-1134. doi: 10.1161/CIRCULATIONAHA.121.058457. Epub 2022 Sep 26. PubMed 36154167 ↗
  • Lakkireddy D, Turagam MK, Yarlagadda B, Dar T, Hamblin M, Krause M, Parikh V, Bommana S, Atkins D, Di Biase L, Mohanty S, Rosamond T, Carroll H, Nydegger C, Wetzel L, Gopinathannair R, Natale A. Myocarditis Causing Premature Ventricular Contractions: Insights From the MAVERIC Registry. Circ Arrhythm Electrophysiol. 2019 Dec;12(12):e007520. doi: 10.1161/CIRCEP.119.007520. Epub 2019 Dec 16. PubMed 31838913 ↗
  • Tardif JC, Kouz S, Waters DD, Bertrand OF, Diaz R, Maggioni AP, Pinto FJ, Ibrahim R, Gamra H, Kiwan GS, Berry C, Lopez-Sendon J, Ostadal P, Koenig W, Angoulvant D, Gregoire JC, Lavoie MA, Dube MP, Rhainds D, Provencher M, Blondeau L, Orfanos A, L'Allier PL, Guertin MC, Roubille F. Efficacy and Safety of Low-Dose Colchicine after Myocardial Infarction. N Engl J Med. 2019 Dec 26;381(26):2497-2505. doi: 10.1056/NEJMoa1912388. Epub 2019 Nov 16. PubMed 31733140 ↗
  • Vandenburgh H, Shansky J, Benesch-Lee F, Barbata V, Reid J, Thorrez L, Valentini R, Crawford G. Drug-screening platform based on the contractility of tissue-engineered muscle. Muscle Nerve. 2008 Apr;37(4):438-47. doi: 10.1002/mus.20931. PubMed 18236465 ↗
  • Stoehr A, Neuber C, Baldauf C, Vollert I, Friedrich FW, Flenner F, Carrier L, Eder A, Schaaf S, Hirt MN, Aksehirlioglu B, Tong CW, Moretti A, Eschenhagen T, Hansen A. Automated analysis of contractile force and Ca2+ transients in engineered heart tissue. Am J Physiol Heart Circ Physiol. 2014 May;306(9):H1353-63. doi: 10.1152/ajpheart.00705.2013. Epub 2014 Feb 28. PubMed 24585781 ↗
  • Ammirati E, Cartella I, Ciabatti M, Colombo G, Masetti M, Pieroni M, Gallone G, Peretto G, Potena L, Scacciavillani R, Raineri C, Caputo A, Pedrotti P, Sormani P, Conti N, Merlo M, Imazio M, Pani A, Ciliberti ML, Gentile P, Pontone G, Villatore A, Pezzullo E, Palazzini M, Casella M, Valsecchi MG, Burzotta F, Carmina V, Garascia A, Scarale AF, Bernasconi DP, Loffredo FS, Narducci ML. Colchicine in patients with chronic inflammatory cardiomyopathy: rationale and design of the CMP-MYTHiC. ESC Heart Fail. 2026 Mar 3;13(2):xvag058. doi: 10.1093/eschf/xvag058. PubMed 41730291 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 20, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT06158698
Lead sponsor
Niguarda Hospital
Collaborators
European Union, Ministry of Health, Italy, Mario Negri Institute for Pharmacological Research, University of Milano Bicocca
Responsible party
Sponsor
First posted
Dec 6, 2023
Start date
Nov 14, 2023
Primary completion
May 2, 2026 (estimated)
Completion
May 2, 2028 (estimated)
Last update
Apr 20, 2026

Study contacts

Enrico Ammirati, MD, PhD
Contact
enrico.ammirati@ospedaleniguarda.it
0264447791 ext. +39
Enrico Ammirati, MD, PhD
principal investigator · ASST Grande Ospedale Metropolitano Niguarda

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Colchicine

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