Steroids for Myocarditis (MYTHS Trial)
Recruiting in Palo Alto (17 mi)
+59 other locations
Age: 18+
Sex: Any
Travel: May be covered
Time Reimbursement: Varies
Trial Phase: Phase 3
Recruiting
Sponsor: Niguarda Hospital
Pivotal Trial (Near Approval)
Prior Safety Data
Approved in 3 jurisdictions
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial does not specify if you need to stop taking your current medications. However, if you are on chronic corticosteroid therapy or other chronic immunosuppressive therapies, you cannot participate in the trial.
What data supports the effectiveness of the drug Methylprednisolone for treating myocarditis?
Research shows that using steroids like prednisone, which is similar to Methylprednisolone, helped improve heart function and symptoms in children with myocarditis, with no significant side effects. Another study found that immunosuppressive therapy, including drugs like prednisolone, improved heart function and symptoms in patients with inflammatory myocarditis.
12345Is methylprednisolone generally safe for humans?
Methylprednisolone has been used safely in many cases, but there are reports of side effects like heart rhythm problems and vision issues when used incorrectly. In a study on heart surgery, it helped reduce some complications without causing known drug-related problems.
678910How does the drug methylprednisolone differ from other treatments for myocarditis?
Methylprednisolone is a corticosteroid that can be administered in high doses either orally or intravenously, which may offer flexibility in treatment compared to other options. Its ability to reduce inflammation by stabilizing cell membranes and decreasing immune response makes it unique, especially in conditions where inflammation is a key issue.
5791112Eligibility Criteria
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.Inclusion Criteria
I am between 18 and 69 years old.
My heart's pumping ability is reduced and its size is within normal limits.
I have heart failure suspected to be due to myocarditis, indicated by high NT-proBNP or BNP levels.
I am in the hospital because doctors think I might have acute myocarditis.
Exclusion Criteria
I am not pregnant or have not tested positive for pregnancy.
I have heart inflammation from cancer immune therapy.
I am on long-term corticosteroid or immunosuppressive therapy, excluding NSAIDs or colchicine.
I am allergic to or cannot take corticosteroids.
I have a chronic infection like HIV or tuberculosis.
I had a cardiac arrest outside of a hospital.
I have a high eosinophil count or hypereosinophilic syndrome.
Participant Groups
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.
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.
Methylprednisolone is already approved in United States, European Union, Canada for the following indications:
🇺🇸 Approved in United States as Medrol for:
- Allergic reactions
- Blood disorders
- Cancer
- Eye diseases
- Immune system disorders
- Inflammatory diseases
- Respiratory diseases
- Skin diseases
🇪🇺 Approved in European Union as Depo-Medrol for:
- Allergic reactions
- Blood disorders
- Cancer
- Eye diseases
- Immune system disorders
- Inflammatory diseases
- Respiratory diseases
- Skin diseases
🇨🇦 Approved in Canada as Solu-Medrol for:
- Allergic reactions
- Blood disorders
- Cancer
- Eye diseases
- Immune system disorders
- Inflammatory diseases
- Respiratory diseases
- Skin diseases
Find A Clinic Near You
Research locations nearbySelect from list below to view details:
University of TexasHouston, TX
University of VirginiaCharlottesville, VA
University of FloridaGainesville, FL
Virginia Commonwealth UniversityRichmond, VA
More Trial Locations
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Who is running the clinical trial?
Niguarda HospitalLead Sponsor
Ministry of Health, ItalyCollaborator
Istituto Di Ricerche Farmacologiche Mario NegriCollaborator
University of Milano BicoccaCollaborator
Regione LombardiaCollaborator
References
[Lymphocytic myocarditis. Response to treatment with immunosuppressive drugs]. [2013]To evaluate immunosuppressive drugs on the treatment of myocarditis.
Acute viral myocarditis: role of immunosuppression: a prospective randomised study. [2021]To conduct a prospective randomised study to show the efficacy of immune suppression with prednisolone, administered at the 3-month duration of acute myocarditis.
Immunosuppressive therapy in inflammatory myocarditis: long-term follow-up. [2019]Sixteen patients (12 male and 4 female, age 2-46 years) with endomyocardial biopsy-proven myocarditis were prospectively evaluated with immunosuppressive therapy including azathioprine and prednisolone in addition to other standard measures. Patients were either in NYHA class IV (n = 12) or class III (n = 4). Twelve patients showed improvement and the remaining 4 continued to deteriorate: 2 died at 1 and 2 months after therapy and the other 2 were lost to follow-up after 4-6 weeks of therapy. Three of the 12 patients who showed significant improvement, after sudden omission of therapy (at 8 weeks, 6 and 8 months) worsened and died. One patient who showed significant improvement died suddenly after 9 months of therapy while playing football. The remaining patients have shown significant clinical and haemodynamic improvement with normalization of myocardial morphology. Serial haemodynamic studies revealed a significant fall in cardiothoracic ratio (before: 62.3 +/- 4.7%; 3 months: 55.1 +/- 3.1%, P less than 0.0001; 6-12 months: 50.6 +/- 1.5%, P less than 0.0001), mean pulmonary artery pressure (before: 34.3 +/- 13.05 mm; 3 months: 20.4 +/- 8.71 mm, P less than 0.01; 6-12 months: 20.0 +/- 2.75 mm, P less than 0.01) and mean pulmonary artery wedge pressure (before: 26.0 +/- 9.07 mm; 3 months 14.0 +/- 5.63 mm, P less than 0.001; 6-12 months: 13.2 +/- 4.57 mm, P less than 0.001). The left ventricular ejection fraction improved from 24.3 +/- 8.36% to 35.8 +/- 9.72% (P less than 0.001) at 3 months and 49.8 +/- 18.2% (P less than 0.0001) at 6-12 months of therapy. Two patients have been subsequently lost to follow-up whereas the remaining 6 patients are on follow-up for 1-4 years after therapy and are doing fine. Our uncontrolled observations suggest that immunosuppressive therapy may be useful in patients with inflammatory myocarditis.
Immunosuppressive therapy in the management of acute myocarditis in children: a clinical trial. [2021]To assess whether steroid therapy influenced the clinical course of myocarditis in a pediatric population, findings in 13 consecutive infants and children (8 female, 5 male) with biopsy-proved myocarditis were reviewed. The mean age was 5.7 +/- 4.8 years (range 1.1 to 14.8). Congestive heart failure was present in all as were ST-T wave changes, cardiomegaly and pulmonary edema on chest roentgenogram. Echocardiography demonstrated pericardial effusion in five patients and mitral regurgitation in eight. Mean left ventricular ejection fraction was 34 +/- 12%. Prednisone was administered to all patients; one patient also received azathioprine. There was one death. All survivors showed clinical improvement with normalization of ECG changes, heart size and systolic function. No significant side effects occurred. Repeat myocardial biopsy in eight patients demonstrated improvement in all eight and elimination of the inflammatory infiltrate in six. Immunosuppressive therapy in this pediatric population appeared useful in improving the clinical course and cardiac function in acute myocarditis with no adverse side effects.
Management of diskogenic pain using epidural and intrathecal steroids. [2019]The use of methylprednisolone acetate (Depo-Medrol) injected by the epidural or intrathecal route for the relief of diskogenic back pain with or without radiculopathy is an adjunct to conservative management useful when conservative measures fail and surgical treatment is under consideration. This is especially true when symptoms have been present for only a few months. Corticosteroids injected in the same manner seem to have little effect on patients with symptoms persisting for periods longer than 3 months or in patients treated previously by surgical methods.
Atrial fibrillation due to oral methylprednisolone in a patient with membranoproliferative glomerulonephritis. [2019]Cardiac adverse effects of intravenous pulse methylprednisolone administration are well known, but there is little information about the cardiac side effects of oral methylprednisolone in the literature. We present a 41 year-old man with membranoproliferative glomerulonephritis in whom developed atrial fibrillation after oral methylprednisolone therapy.
Retinal necrosis secondary to inadvertent intravitreal methylprednisolone acetate (depo-medrol) injection during pars plana vitrectomy. [2014]Methylprednisolone acetate (Depo-Medrol, Pfizer, New York) is a depot corticosteroid that is commonly injected periorbitally to treat various ophthalmologic conditions. Accidental intravitreal injections secondary to globe perforations have resulted in rapid retinal toxicity. To their knowledge, the authors report the first case of inadvertent intravitreal methylprednisolone acetate injection during pars plana vitrectomy.
The effects of methylprednisolone on the complications of coronary artery surgery. [2019]Complications of coronary artery surgery were analyzed in a prospective controlled study of 150 patients, one group receiving methylprednisolone before temporary cardiopulmonary bypass. The patient population was comparable in both the groups. The number of deaths were the same in both the groups, myocardial infarction and cardiac arrhythmias were definitely lower in the Solu-Medrol group. Cerebral vascular accidents were higher in the control group and there were none in the drug treated group. Incidences of pulmonary embolism was reduced by the drug. Oxygen consumption by the tissues was higher in the Solu-Medrol treated group. There were no known complications of the drug, such as stress ulcer and infection. One patient did receive prophylactic antibiotics. Solu-Medrol was deliberately given in patients who were known to have uncomplicated duodenal ulcer. Post-operative bleeding in patients with duodenal ulcer was not noted. This could be explained due to the short acting nature of Solu-Medrol. We feel that Solu-Medrol does minimize serious sequelae of heart-lung machine in coronary artery surgery.
Retinal and choroidal microvascular embolism after intranasal corticosteroid injection. [2022]Two patients had uniocular visual loss after methylprednisolone acetate (Depo-Medrol) injection for control of chronic inflammatory conditions in the nose. The cause of the visual loss was embolic retinal and choroidal vascular occlusion. The emboli were presumably aggregates of microcrystals of methylprednisolone acetate.
Depo-Medrol and myelographic arachnoiditis. [2021]This study was undertaken to see if patients who had a radiological diagnosis of arachnoiditis attributed to methylprednisolone acetate (Depo-Medrol, Upjohn Pty Limited) had the clinical syndrome of arachnoiditis.
Preliminary study related the incidence of methylprednisolone pulse therapy in patients visited multiple sclerosis clinic located at the isfahan kashani hospital. [2022]To manage relapsing-remitting multiple sclerosis (MS) in the course of acute exacerbations, methylprednisolone (MP) (Medrol or Solu-Medrol), has the ability to lock the injured blood-brain barrier and decrease irritation in the central nervous system. The aim of this preliminary study was to investigate the frequency and time interval related to MP pulse therapy in patients with MS.
High dose oral methylprednisolone in patients with rheumatoid arthritis: pharmacokinetics and clinical response. [2019]A commercially available 1.0 g intravenous (i.v.) dosage formulation of methylprednisolone, as the sodium hemisuccinate salt (Solu Medrol, Upjohn) was administered both parenterally and orally (pulse steroid therapy) on separate occasions, to eight elderly (mean 65 y) patients with active rheumatoid arthritis. The relative oral bioavailability of the sterol was 69.2%. Elimination of methylprednisolone was prolonged when given orally; the mean residence times were 7.23 h and 3.94 h for oral and i.v. administrations, respectively. Clinical response to pulse steroid therapy was no different with respect to route of administration. There were no significant differences in standard clinical and laboratory assessments of disease activity when the two therapies were compared. Oral administration of methylprednisolone in patients requiring high-dose pulse steroid therapy is convenient and avoids the discomfort and inconvenience associated with i.v. administration.