Phase 3 Cardiomyopathy Trial, Recruiting
Who may be able to join
AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI
Who might be able to join this trial:
- You have been admitted to hospital with a suspected condition called myocarditis (inflammation of the heart muscle)
- You are between 18 and 69 years old
- You have signs of acute heart failure, confirmed by a blood test showing certain heart stress markers above a specific level (NT-proBNP ≥1600 pg/mL or BNP ≥400 pg/mL)
- A heart ultrasound (echocardiogram) shows that your heart's pumping ability is reduced below a certain level, and your heart is not abnormally enlarged
- A blood test shows raised levels of troponin (a marker of heart muscle damage) at least 3 times above the normal limit
- Your heart symptoms started within the 3 weeks before joining the trial
- If you are 46 years old or older, a scan of your heart's arteries has been done to rule out blocked arteries (unless myocarditis has already been confirmed by a tissue sample)
- You are enrolled in the trial within 5 days (120 hours) of being admitted to hospital
Who may not be able to join:
- You already have a known autoimmune disease (where your immune system attacks your own body) that would typically require immune-suppressing treatment
- You are already taking steroid tablets or injections long-term, or other long-term immune-suppressing medications
- You have a known allergy or medical reason why you cannot take corticosteroids (steroid medicines)
- You have a persistently high level of a certain type of white blood cell (eosinophils) in your blood, or a known condition causing this
- Your myocarditis is believed to be caused by cancer immunotherapy drugs you are currently taking
- You have a previously known long-term heart condition (not including a previous episode of myocarditis where your heart function fully recovered)
- There is evidence of an active bacterial or fungal infection, or a blood test suggests a serious infection (procalcitonin level above 10 ng/mL, if this test is available at the hospital)
- You have a known long-term infectious disease such as HIV or tuberculosis
- You had a cardiac arrest outside of a hospital before joining the trial
- You have been on temporary mechanical heart support for more than 48 hours before joining the trial
- You are considered too unwell to safely receive temporary mechanical heart support (for example, due to severe failure of multiple organs that cannot be reversed)
- Your heart ultrasound shows signs of another heart condition, such as an infection of the heart valves (endocarditis)
- You are already taking part in another clinical trial
- You are pregnant or have a positive pregnancy test (applies to women aged 18–50)
- You have another serious illness where you are not expected to live longer than 12 months, or any other condition that the trial doctor feels could put you at risk or affect the trial results
Important: Always verify eligibility with the trial site directly before applying.
Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.
Contact this trial
Phone: +39 0264447791
Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.
GP referral letter
Print a one-page summary to share with your doctor.
Trial details
Where this trial is recruiting
Primary endpoints
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.
Can't join this trial?
Data last synced from ClinicalTrials.gov: 26 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.