What side effects are associated with this type of intervention?

Pulsed intravenous (IV) methylprednisolone, commonly used to treat myocarditis, can have several side effects. These include increased risk of infections, elevated blood sugar levels, hypertension, mood swings, and gastrointestinal issues such as ulcers. Long-term use may lead to osteoporosis, weight gain, and Cushing's syndrome. It is important for patients to discuss these potential side effects with their healthcare provider to manage and mitigate risks effectively.

What prior FDA approvals exist?

There are no specific FDA-approved treatments exclusively for myocarditis. However, treatments that reduce inflammation and modulate the immune response, such as pulsed intravenous (IV) methylprednisolone, are commonly used in clinical practice. These treatments are often part of broader immunosuppressive therapy regimens aimed at managing the inflammatory response in myocarditis. Other related drugs used in similar contexts include oral glucocorticoids like prednisone and immunosuppressive agents such as azathioprine and methotrexate.

What other types of research exist?

Promising novel alternatives to pulsed intravenous (IV) methylprednisolone for myocarditis patients include the use of IL-1 receptor antagonists such as anakinra, which has shown efficacy in reducing inflammation. Another potential alternative is the use of biologic agents like tocilizumab, which targets IL-6 and has been explored for its anti-inflammatory properties. These therapies represent emerging options that may offer benefits in managing myocarditis by modulating the immune response more specifically.

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Corticosteroid

Steroids for Myocarditis (MYTHS Trial)

Q: What is the mechanism of action of this treatment?

The most common treatments for myocarditis, such as pulsed intravenous (IV) methylprednisolone, work primarily by reducing inflammation and modulating the immune response. Methylprednisolone, a type of glucocorticoid, inhibits various inflammatory pathways and decreases the activity of the immune system, which helps to reduce the inflammation of the heart muscle. This is particularly important for myocarditis patients because excessive inflammation can lead to heart muscle damage, impaired heart function, and potentially life-threatening complications. By controlling inflammation, these treatments aim to preserve heart function and improve patient outcomes.

Phase 3

Recruiting

Research Sponsored by Niguarda Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age 18 years or older and below 70 years (18-69 years)

Left ventricular ejection fraction (LVEF)<41% and left ventricular end diastolic diameter (LV-EDD)<56 mm (parasternal long-axis view) on echocardiogram

Must not have

Pregnant women (known pregnancy) or POSITIVE human chorionic gonadotropin (HCG) test measures (urine/blood) for women of 18-50 years of age

Myocarditis associated with the ongoing administration of anti-cancer immune checkpoint inhibitor (ICI) agents

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6 months from patients enrollment

Awards & highlights

Pivotal Trial

Summary

This trial tests if giving high doses of a steroid medication can help patients with severe heart inflammation recover better. The treatment targets those with serious heart issues, aiming to reduce inflammation and improve heart function.

Who is the study for?

Adults aged 18-69 with recent onset of cardiac symptoms, suspected acute myocarditis, heart failure signs, specific levels of NT-proBNP or BNP, reduced heart function on echocardiogram, and elevated troponin. Excludes those with autoimmune disorders, severe illness precluding treatment initiation, other trial participation, chronic corticosteroid/immunosuppressive therapy use, pregnancy, chronic infections like HIV/tuberculosis, out-of-hospital cardiac arrest history.

What is being tested?

The MYTHS trial is testing the effectiveness of pulsed IV methylprednisolone (a steroid) against a saline solution placebo in patients with Acute Myocarditis. It's a phase III study where participants are randomly assigned to receive either the steroid treatment or placebo alongside standard care.

What are the potential side effects?

Potential side effects from methylprednisolone may include increased infection risk due to immune system suppression; mood swings; high blood pressure; blood sugar changes; stomach ulcers; and possible allergic reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am between 18 and 69 years old.

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My heart's pumping ability is reduced and its size is within normal limits.

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I have heart failure suspected to be due to myocarditis, indicated by high NT-proBNP or BNP levels.

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I am in the hospital because doctors think I might have acute myocarditis.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not pregnant or have not tested positive for pregnancy.

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I have heart inflammation from cancer immune therapy.

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I am on long-term corticosteroid or immunosuppressive therapy, excluding NSAIDs or colchicine.

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I am allergic to or cannot take corticosteroids.

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I have a chronic infection like HIV or tuberculosis.

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I had a cardiac arrest outside of a hospital.

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I have a high eosinophil count or hypereosinophilic syndrome.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6 months from patients enrollment

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6 months from patients enrollment

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6 months from patients enrollment for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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.

Secondary study objectives

Change in LVEF on echocardiogram after 5 days from randomization

Change in heart rate (HR) on ECG after 3 days from randomization

Change of troponin levels after 5 days from randomization

+8 more

Other study objectives

Safety endpoints

Awards & Highlights

Pivotal Trial

The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Experimental armExperimental Treatment1 Intervention

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

Group II: Control armPlacebo Group1 Intervention

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

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Methylprednisolone

2015

Completed Phase 4

~2280

0 / 11Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

The most common treatments for myocarditis, such as pulsed intravenous (IV) methylprednisolone, work primarily by reducing inflammation and modulating the immune response. Methylprednisolone, a type of glucocorticoid, inhibits various inflammatory pathways and decreases the activity of the immune system, which helps to reduce the inflammation of the heart muscle. This is particularly important for myocarditis patients because excessive inflammation can lead to heart muscle damage, impaired heart function, and potentially life-threatening complications. By controlling inflammation, these treatments aim to preserve heart function and improve patient outcomes.