Myocarditis Acute study: Methylprednisolone vs Saline solution
Official title MYTHS - MYocarditis THerapy With Steroids
ClinicalTrials.gov ID: NCT05150704
What this study is testing
What is Methylprednisolone?
Methylprednisolone is an investigational medicine, given as an IV infusion (through a vein), being studied as a potential treatment for myocarditis acute.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether a short course of IV methylprednisolone (a steroid) works better than standard therapy for acute myocarditis.
- Who it's for
- You may be able to join if you have been diagnosed with acute myocarditis and are receiving maximal medical support.
- What's involved
- You will be randomly assigned, like a coin toss, to receive either the steroid IV treatment or the usual care. The study is single blind, so you will not know which one you get.
- Phase 3: a large, late-stage study
- Time commitment: about 30 months
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 69
You may be able to join if
- 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-terminal pro-B-type natriuretic peptide (NT-proBNP) concentration of 1600 pg/mL or...
- Left ventricular ejection fraction (LVEF)\<41% and left ventricular end diastolic diameter (LV-EDD)\<56 mm (parasternal long-axis view) on...
- Increased troponin (3x upper reference limit [URL]) at the time of randomization;
You likely can't join if
- Known systemic autoimmune disorder or other conditions at the time of randomization where immunosuppression is assumed useful.
- Patients already on oral/IV chronic corticosteroid therapy or other chronic immunosuppressive therapies (colchicine or nonsteroidal anti-inflammatory...
- Contraindication to corticosteroids, including allergies to this medication and its excipients;
- Patients with persistent peripheral eosinophilia (persistent Eosinophil count \>7% of the leukocytes) or known hypereosinophilic syndrome at the time...
- Myocarditis associated with the ongoing administration of anti-cancer immune checkpoint inhibitor (ICI) agents;
- Previously known chronic cardiac disease (i.e., previous cardiomyopathy) that does NOT include previous myocarditis if there is a functional recovery...
See the full eligibility 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-terminal pro-B-type natriuretic peptide (NT-proBNP) concentration of 1600 pg/mL or more or a B-type natriuretic peptide (BNP) concentration of 400 pg/mL...
- Left ventricular ejection fraction (LVEF)\<41% and left ventricular end diastolic diameter (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 people ≥46 years of age, in case myocarditis is not histologically proven;
- Randomization within 120 hours from hospital admission.
- Known systemic autoimmune disorder or other conditions at the time of randomization where immunosuppression is assumed useful.
- Patients already on oral/IV chronic corticosteroid therapy or other chronic immunosuppressive therapies (colchicine or nonsteroidal anti-inflammatory drugs [NSAIDs] are not considered immunosuppressive drugs);
- Contraindication to corticosteroids, including allergies to this medication and its excipients;
- Patients with persistent peripheral eosinophilia (persistent Eosinophil count \>7% of the leukocytes) or known hypereosinophilic syndrome at the time of randomization.
- Myocarditis associated with the ongoing administration of anti-cancer immune checkpoint inhibitor (ICI) agents;
- Previously known chronic cardiac disease (i.e., previous cardiomyopathy) that does NOT include previous myocarditis if there is a functional recovery at the time of screening);
- Evidence of active bacterial or fungal infectious disease (presence of fever or increased C-reactive protein are not considered exclusion criteria), or suspected bacterial/fungal infection associated with increased...
- 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 multiorgan failure);
- 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) test measures (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 of the Investigator, may either put the participants at risk...
The study team makes the final eligibility decision.
Where it is enrolling
- San Diego, California, United States
- Charlottesville, Virginia, United States
- Graz, Austria
- Vienna, Austria
- Aalst, Belgium
- Edegem, Belgium
- Hasselt, Belgium
- Leuven, Belgium
- Brno, Czechia
- Prague, Czechia
- Ancona, Italy
- Bergamo, Italy
- Bologna, Italy
- Brescia, Italy
- Cagliari, Italy
- Chieti, Italy
- Florence, Italy
- Genova, Italy
- Lecco, Italy
- Milan, Italy
+ 15 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The study runs about 30 months per participant, based on its public description. The team confirms the exact schedule and number of visits before you enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 69 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at San Diego, California, United States; Charlottesville, Virginia, United States; Graz, Austria; Vienna, Austria; Aalst, Belgium; Edegem, Belgium and 29 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.