Recruiting
Phase 3

Steroids

Sponsor:

Niguarda Hospital

Code:

NCT05150704

Conditions

Myocarditis Acute

Eligibility Criteria

Sex: All

Age: 18 - 69

Healthy Volunteers: Not accepted

Interventions

Methylprednisolone

saline solution

Study Details

Brief summary:

This is a phase III, multi-center international, single blind randomized controlled trial to test the efficacy of pulsed intravenous (IV) methylprednisolone versus standard therapy on top of maximal support in patients with Acute myocarditis (AM).

Conditions

Myocarditis Acute

Study ID

NCT05150704

Start date

Oct 7, 2021

Status verified date

Jul, 2025

Completion date

Dec, 2028

Anticipated

Primary completion date

Mar, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 69

Healthy Volunteers: Not accepted

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-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 or more;
  • 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 subjects ≥46 years of age, in case myocarditis is not histologically proven;
  • Randomization within 120 hours from hospital admission.

Exclusion Criteria:

  • Known systemic autoimmune disorder or other conditions at the time of randomization where immunosuppression is assumed useful. Patients in whom a systemic autoimmune disorder will be diagnosed during hospitalization will be included in the study if randomized, including patients with a diagnosis of cardiac sarcoidosis or giant cell myocarditis (GCM). Both patients included in the corticosteroids-treatment arm or in the placebo-treatment arm can receive the standard immunosuppressive therapy used in the center since the diagnosis of a systemic autoimmune disorder, or cardiac sarcoidosis or GCM;
  • 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. Patients in whom eosinophilic myocarditis will be diagnosed on endomyocardial biopsy (EMB) will be included in the study if already randomized. Both patients included in the corticosteroids-treatment arm or in the placebo-treatment arm can receive the standard immunosuppressive therapy used in the center since the diagnosis;
  • 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 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 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 because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.

Study Design

Enrollment

288 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Experimental arm

Pulsed corticosteroid therapy (methylprednisolone 1 g IV qd for 3 days diluted in saline solution 250 mL) on top of standard therapy and maximal supportive care

placebo comparator: Control arm

Placebo (saline solution 250 mL IV qd for 3 days) on top of standard therapy and maximal supportive care.

Interventions

Methylprednisolone

Pulsed corticosteroid therapy (methylprednisolone 1 g IV qd for 3 days diluted in saline solution 250 mL) on top of standard therapy and maximal supportive care

saline solution

Placebo (saline solution 250 mL IV qd for 3 days) on top of standard therapy and maximal supportive care.

Primary outcome measure

  • Time from randomization to the first event among: all-cause death, HTx, long-term LVAD implant, need for an upgrading of the t-MCS, VT/VF treated with DC shock, first rehospitalization due to HF or ventricular arrhythmias, or AV block. [ Time Frame: 6 months from patients enrollment ]

Central Contacts and Locations

Central contacts

Enrico Ammirati, MD, PhD

+39 0264447791enrico.ammirati@ospedaleniguarda.it

Locations

University of California San Diego

Recruiting

San Diego, California, United States, 92093

University of Virginia

Recruiting

Charlottesville, Virginia, United States, 22903

More Information

Sponsor

Niguarda Hospital

Last update posted

Jul 31, 2025

Last verified

Jul, 2025

Keywords

  • Acute Myocarditis
  • Corticosteroid therapy
  • Myocarditis
  • Trial
  • Immunosuppression
  • Acute heart failure
  • Fulminant acute myocarditis

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Niguarda Hospital on 2025-07-31.