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Corticosteroid
Steroids for Myocarditis (MYTHS Trial)
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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 months from patients enrollment
Awards & highlights
MYTHS Trial Summary
This trial tests whether adding a steroid to standard therapy can help patients with a heart condition called myocarditis.
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.Check my eligibility
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.See study design
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.
MYTHS Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
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.
Select...
I am in the hospital because doctors think I might have acute myocarditis.
MYTHS Trial 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
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
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 outcome measures
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 moreOther outcome measures
Safety endpoints
MYTHS 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
Find a Location
Who is running the clinical trial?
Niguarda HospitalLead Sponsor
72 Previous Clinical Trials
29,001 Total Patients Enrolled
2 Trials studying Myocarditis
254 Patients Enrolled for Myocarditis
Ministry of Health, ItalyOTHER_GOV
55 Previous Clinical Trials
112,716 Total Patients Enrolled
2 Trials studying Myocarditis
160 Patients Enrolled for Myocarditis
Istituto Di Ricerche Farmacologiche Mario NegriOTHER
29 Previous Clinical Trials
44,366 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have an active bacterial or fungal infection.I have an autoimmune disorder or a condition that benefits from immunosuppression.The echocardiogram shows signs of other heart problems, like endocarditis.I am between 18 and 69 years old.I am not pregnant or have not tested positive for pregnancy.I have a history of heart disease but not inflammation of the heart muscle if I've recovered.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 do not have any severe illnesses that could shorten my life to under a year.Your troponin levels are three times higher than the normal limit when you are being chosen for the study.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 am in the hospital because doctors think I might have acute myocarditis.I am over 45 and had a test to check my heart's arteries if I don't have a confirmed heart muscle inflammation.You took any other investigational medication more than 48 hours before the study starts.You are too sick and have severe, irreversible organ failure.I have a high eosinophil count or hypereosinophilic syndrome.I started having heart symptoms less than 3 weeks ago.
Research Study Groups:
This trial has the following groups:- Group 1: Control arm
- Group 2: Experimental arm
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Is Methylprednisolone a common medication for research trials?
"As of now, there are 152 active studies related to Methylprednisolone with 40 trials in the third stage. The majority of these clinical trials take place in Houston, Texas; however, there are 6755 total locations running methylprednisolone clinical trials."
Answered by AI
Are people with the disease still being welcomed into this experiment?
"The correct, as indicated by the listing on clinicaltrials.gov. This particular study was first made available on 10/7/2021 and is currently recruiting patients for participation. 2 medical centres are involved in the trial, which aims to enroll 288 individuals in total."
Answered by AI
If I meet the qualifications, may I sign up for this clinical trial?
"Eligible patients for this study must be below 70 years old (18-69), have myocarditis, and were recently hospitalized with a suspected AM. Furthermore, participants must meet the following two conditions: they must be randomized within 72 hours of hospital admission and admitted to the hospital for suspicion of AM."
Answered by AI
Why is Methylprednisolone prescribed to patients?
"Methylprednisolone is most commonly used to treat ophthalmia and sympathetic. However, it can also be effective in treating scalp structure, temporal arteritis, and lupus erythematosus."
Answered by AI
Is this clinical trial only open to those who are under the age of 65?
"This clinical trial's age requirements for enrollment are between 18 and 69 years old."
Answered by AI
To what degree does Methylprednisolone put people's health at risk?
"Methylprednisolone has gone through multiple rounds of testing with some data supporting efficacy, making it a safe medication with a score of 3."
Answered by AI
Who else is applying?
What state do they live in?
Texas
What site did they apply to?
University of Texas
What portion of applicants met pre-screening criteria?
Met criteria
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