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Search / Trial NCT06522100

Corticoid Therapy in Acute Myocarditis

Launched by ASSISTANCE PUBLIQUE - HÔPITAUX DE PARIS · Jul 22, 2024

Trial Information

Current as of August 21, 2025

Not yet recruiting

Keywords

Acute Myocarditis Corticoids Left Ventricular Dysfunction

ClinConnect Summary

This clinical trial, titled "Corticoid Therapy in Acute Myocarditis," aims to study the effects of corticosteroid treatment in patients diagnosed with acute myocarditis, a serious condition where the heart muscle becomes inflamed. The researchers hope to determine if this treatment can improve heart function and overall health in affected individuals. The trial is currently not recruiting participants, but when it begins, it will include adults aged 18 and older who have specific symptoms and test results indicating active myocarditis, such as chest pain, heart failure, or irregular heart rhythms.

To be eligible for this trial, participants must have a diagnosis of acute myocarditis confirmed by certain medical tests and show reduced heart function, but they should not have other heart diseases or conditions that require steroids. Participants can expect to receive the study treatment while being closely monitored by the medical team throughout the trial. It’s important to note that individuals who cannot commit to the study visits or have certain health issues may not be able to participate. If you or a loved one has questions about this trial or the condition, it’s a good idea to discuss them with a healthcare provider.

Gender

ALL

Eligibility criteria

  • Inclusion Criteria:
  • Age ≥ 18 years
  • Written signed informed consent
  • Affiliation to the French health care system or to another social protection scheme with the exception of State Medical Aid
  • * Active myocarditis defined by (all items are required):
  • Acute chest pain and/or unexplained heart failure and/or syncope and/or sustained ventricular arrhythmias and/or aborted sudden death and/or cardiogenic shock and/or ECG modification (atrioventricular block or bundle branch block or sinus arrest or ST or T waves change or ventricular arrhythmia or atrial fibrillation or abnormal Q waves)
  • And troponin rise (1,5 times the normal range)
  • And diagnosis of active myocarditis on Cardiac Magnetic Resonance (according to Lake-Louise criteria) or by histological evidence on endomyocardial biopsy (Dallas's criteria)
  • Left-ventricular dysfunction defined as LVEF \< 50% and/or GLS \< -16% assessed with 2D-TTE
  • Normal coronary angiography or CT Scan (without stenosis \> 50%) during the previous year
  • Exclusion Criteria:
  • Active coronary disease
  • Other causes of chronic heart failure (coronary artery disease, primary valvular heart disease, congenital heart disease)
  • Other etiology of myocarditis requiring corticosteroids treatment as giant cells myocarditis, eosinophilic myocarditis and cardiac sarcoidosis or immune checkpoint inhibitor myocarditis
  • Other auto-immune or inflammatory disease requiring corticosteroids treatment within 6 months before enrolment
  • Pregnancy or breastfeeding
  • Woman of childbearing potential without effective method of birth control (included contraceptive methods with a failure rate of \< 1% per year include bilateral tubal ligation, male sterilization, established proper use of hormonal contraceptives that inhibit ovulation, hormone-releasing intrauterine devices, and copper intrauterine devices)
  • Patient deprived of liberty or under Curatorship/Tutorship, safeguard of justice, according to French law
  • Foreseeable inability, according to the investigator, to participate in all the visits, treatments and measures provided for in the protocol
  • Patient not speaking or understanding French
  • Concomitant participation in another clinical trial on medical product for human use, to a clinical investigation on a medical device, to interventional study involving human participants or in the exclusion period at the end of a previous clinical trial on medical product for human use, a clinical investigation on a medical device, or study involving human participants. Participation in non-interventional research is permitted.
  • Any medical and/or cognitive condition which limits the ability of participant to participate in study
  • * Contra-indication linked to steroids (Methylprednisolone and Prednisone) according to summary of product characteristics:
  • Any infectious condition excluding the specified therapeutic indications of Methylprednisolone and Prednisone
  • Certain evolving viruses (notably hepatitis, herpes, chickenpox, shingles)
  • Psychotic states not yet controlled by treatment
  • Recent live vaccines or live attenuated vaccines in patients receiving dosages greater than 20 mg/day of prednisone equivalent for more than two weeks and during the 3 months following the cessation of corticosteroid therapy (risk of generalized vaccine disease possibly fatal)
  • Hypersensitivity to the active substances or to any of the excipients
  • * Contra-indication linked to auxiliary drugs according to respective summary of product characteristics:
  • Beta-blockade
  • Angiotensin-converting-enzyme inhibitor (ACE-I)
  • Angiotensin receptor blockers (ARB)
  • Mineralocorticoid antagonists (MRA)
  • Angiotensin receptor-neprilysin inhibitor (ARNi)

About Assistance Publique Hôpitaux De Paris

Assistance Publique - Hôpitaux de Paris (AP-HP) is a leading public hospital system in France, renowned for its commitment to healthcare excellence and innovative medical research. As a prominent clinical trial sponsor, AP-HP plays a pivotal role in advancing medical knowledge and improving patient care through rigorous scientific investigations across a wide range of therapeutic areas. With a focus on collaboration and interdisciplinary approaches, AP-HP leverages its extensive network of hospitals and expert clinicians to facilitate high-quality clinical trials that adhere to the highest ethical and regulatory standards, ultimately aiming to translate research findings into tangible health benefits for diverse patient populations.

Locations

Patients applied

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Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported