Phase
Condition
Dermatomyositis (Connective Tissue Disease)
Chest Pain
Treatment
Methylprednisolone
saline solution
Clinical Study ID
Ages 18-69 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Patients admitted to hospital for suspected AM
Age 18 years or older and below 70 years (18-69 years)
Acute HF with clinically suspected acute myocarditis based on an N-terminalpro-B-type natriuretic peptide (NT-proBNP) concentration of 1600 pg/mL or more or aB-type natriuretic peptide (BNP) concentration of 400 pg/mL or more;
Left ventricular ejection fraction (LVEF)<41% and left ventricular end diastolicdiameter (LV-EDD)<56 mm (parasternal long-axis view) on echocardiogram;
Increased troponin (3x upper reference limit [URL]) at the time of randomization;
Clinical onset of cardiac symptoms within 3 weeks from randomization;
Excluded coronary artery disease by coronary angiogram in subjects ≥46 years of age,in case myocarditis is not histologically proven;
Randomization within 120 hours from hospital admission.
Exclusion
Exclusion Criteria:
Known systemic autoimmune disorder or other conditions at the time of randomizationwhere immunosuppression is assumed useful. Patients in whom a systemic autoimmunedisorder will be diagnosed during hospitalization will be included in the study ifrandomized, including patients with a diagnosis of cardiac sarcoidosis or giant cellmyocarditis (GCM). Both patients included in the corticosteroids-treatment arm or inthe placebo-treatment arm can receive the standard immunosuppressive therapy used inthe center since the diagnosis of a systemic autoimmune disorder, or cardiacsarcoidosis or GCM;
Patients already on oral/IV chronic corticosteroid therapy or other chronicimmunosuppressive therapies (colchicine or nonsteroidal anti-inflammatory drugs [NSAIDs] are not considered immunosuppressive drugs);
Contraindication to corticosteroids, including allergies to this medication and itsexcipients;
Patients with persistent peripheral eosinophilia (persistent Eosinophil count >7% ofthe leukocytes) or known hypereosinophilic syndrome at the time of randomization.Patients in whom eosinophilic myocarditis will be diagnosed on endomyocardial biopsy (EMB) will be included in the study if already randomized. Both patients included inthe corticosteroids-treatment arm or in the placebo-treatment arm can receive thestandard immunosuppressive therapy used in the center since the diagnosis;
Myocarditis associated with the ongoing administration of anti-cancer immunecheckpoint inhibitor (ICI) agents;
Previously known chronic cardiac disease (i.e., previous cardiomyopathy) that doesNOT include previous myocarditis if there is a functional recovery at the time ofscreening);
Evidence of active bacterial or fungal infectious disease (presence of fever orincreased C-reactive protein are not considered exclusion criteria), or suspectedbacterial/fungal infection associated with increased levels of procalcitonin (cut-off >10 ng/mL), if the laboratory exam is available in the center;
Known chronic infective disease, such as HIV infection or tuberculosis;
out-of-hospital cardiac arrest;
t-MCS instituted more than 48 hours before randomization;
Patients clinically judged too sick to initiate t-MCS (i.e., irreversible multiorganfailure);
Echocardiographic presence of images suggestive of other cardiac diseases (i.e.endocarditis)
Participants involved in another clinical trial;
Pregnant women (known pregnancy) or POSITIVE human chorionic gonadotropin (HCG) testmeasures (urine/blood) for women of 18-50 years of age.
Any other significant disease with expected life expectancy <12 months (i.e.,evidence of irreversible severe brain injury) or disorder which, in the opinion ofthe Investigator, may either put the participants at risk because of participationin the trial, or may influence the result of the trial, or the participant's abilityto participate in the trial.
Study Design
Study Description
Connect with a study center
Medical University of Graz
Graz,
AustriaSite Not Available
Medical University Innsbruck
Innsbruck,
AustriaSite Not Available
Medical University of Wien
Wien,
AustriaSite Not Available
Onze Lieve Vrouwziekenhuis
Aalst,
BelgiumSite Not Available
Antwerp University Hospital
Edegem,
BelgiumActive - Recruiting
Jessa Hospital Hasselt
Hasselt,
BelgiumActive - Recruiting
University Hospitals Leuven
Leuven,
BelgiumActive - Recruiting
Masaryk University and St. Anne's University Hospital
Brno,
CzechiaSite Not Available
Charles University in Prague and General University Hospital
Prague,
CzechiaSite Not Available
Institute for Clinical and Experimental Medicine - IKEM
Prague,
CzechiaSite Not Available
Rigshospitalet and University of Copenhagen
Copenhagen,
DenmarkSite Not Available
Heart and Lung Center, Helsinki University Hospital
Helsinki,
FinlandSite Not Available
Hospices Civils de Lyon, Lyon 08, Rhône-Alpes
Lyon,
FranceSite Not Available
Université Nantes, CHU Nantes, CNRS, INSERM, l'institut du thorax
Nantes,
FranceSite Not Available
Hôpital Pitié-Salpêtrière (Assistance Publique-Hôpitaux de Paris)
Paris,
FranceSite Not Available
Charité - University Medicine Berlin, Campus Virchow Klinikum
Berlin,
GermanySite Not Available
Onassis Cardiac Surgery Centre
Athens,
GreeceSite Not Available
AOU Ospedali Riuniti Umberto I°-Lancisi-Salesi di Ancona
Ancona,
ItalyActive - Recruiting
ASST Papa Giovanni XXIII
Bergamo,
ItalyActive - Recruiting
Policlinico S.Orsola-Malpighi
Bologna,
ItalyActive - Recruiting
ASST Spedali Civili
Brescia,
ItalyActive - Recruiting
Azienda Ospedaliera "G.Brotzu"
Cagliari,
ItalyActive - Recruiting
P.O. SS. Annunziata Chieti -ASL 2 Abruzzo
Chieti,
ItalySite Not Available
Azienda Ospedaliero-Universitaria Careggi
Firenze,
ItalyActive - Recruiting
Ospedale Policlinico San Martino, IRCCS
Genova,
ItalyActive - Recruiting
Azienda Socio-Sanitaria Territoriale (ASST) di Lecco
Lecco,
ItalySite Not Available
ASST Grande Ospedale Metropolitano Niguarda
Milano,
ItalyActive - Recruiting
Centro Cardiologico Monzino
Milano,
ItalyActive - Recruiting
ASST Monza, Ospedale San Gerardo
Monza,
ItalyActive - Recruiting
Azienda Ospedaliera Specialistica dei Colli - Ospedale Monaldi
Napoli,
ItalyActive - Recruiting
Istituto Mediterraneo per i Trapianti e le Terapie ad alta specializzazione (IRCCS ISMETT)
Palermo,
ItalySite Not Available
Azienda Ospedaliero Universitaria di Parma
Parma,
ItalyActive - Recruiting
Fondazione IRCCS Policlinico San Matteo
Pavia,
ItalyActive - Recruiting
Fondazione Toscana Gabriele Monasterio
Pisa,
ItalyActive - Recruiting
Azienda Ospedaliera San Camillo Forlanini di Roma
Roma,
ItalyActive - Recruiting
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma,
ItalyActive - Recruiting
Azienda Ospedaliera Universitaria Senese, Policlinico Santa Maria alle Scotte
Siena,
ItalyActive - Recruiting
Azienda Ospedaliera Universitaria Città della Salute e della Scienza di Torino
Torino,
ItalyActive - Recruiting
Presidio Ospedaliero Universitario "Santa Maria della Misericordia"
Udine,
ItalyActive - Recruiting
Nagoya University Graduate School of Medicine
Nagoya,
JapanSite Not Available
National Cerebral and Cardiovascular Center
Osaka,
JapanSite Not Available
University Medical Centre Ljubljana
Ljubljana,
SloveniaActive - Recruiting
Complexo Hospitalario Universitario A Coruña (CHUAC)
A Coruña,
SpainActive - Recruiting
Barcelona
Barcelona,
SpainSite Not Available
Bellvitge University Hospital
Barcelona,
SpainActive - Recruiting
Hospital Universitario Vall d'Hebron
Barcelona,
SpainActive - Recruiting
Hospital 12 de Octubre
Madrid,
SpainActive - Recruiting
Hospital General Universitario Gregorio Marañón in Madrid
Madrid,
SpainActive - Recruiting
Hospital Universitario Puerta de Hierro Majadahonda
Madrid,
SpainActive - Recruiting
Hospital Universitario Virgen de la Arrixaca
Murcia,
SpainActive - Recruiting
Hospital Universitario Virgen de la Victoria
Málaga,
SpainActive - Recruiting
La Fe University Hospital
Valencia,
SpainSite Not Available
Sahlgrenska Universitetssjukhuset
Göthenburg,
SwedenSite Not Available
Lund University and Skåne University Hospital
Lund,
SwedenSite Not Available
Karolinska Universitetssjukhuset
Stockholm,
SwedenSite Not Available
University of California San Diego
San Diego, California 92093
United StatesActive - Recruiting
University of Florida
Gainesville, Florida 32611-5500
United StatesSite Not Available
University of Texas
Houston, Texas 77204
United StatesSite Not Available
University of Virginia
Charlottesville, Virginia 22903
United StatesActive - Recruiting
Virginia Commonwealth University
Richmond, Virginia 23284
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.