Richmond, VANCT05150704Now EnrollingIRB Ready

Acute Myocarditis Clinical Trial in Richmond, VA

Access cutting-edge acute myocarditis treatment through this phase 3 clinical trial at a research site in Richmond. Study-provided care at no cost to qualified participants.

Sponsored by Niguarda Hospital

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Expert Care in Richmond

Access acute myocarditis specialists at no cost

IRB Approved

This study follows strict safety protocols and ethical guidelines

No-Cost Care

All study-related acute myocarditis treatment provided free

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Check if you qualify for this acute myocarditis clinical trial in Richmond, VA

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Your information is protected and will only be shared with the research team.

Why Participate?

  • No-Cost Study Care

  • Local to Richmond

    Convenient for VA residents

  • Cutting-Edge Treatment

    Access to innovative therapies

  • Expert Medical Care

    Close monitoring by specialists

  • Possible Compensation*

    For time and travel

*Compensation varies by study. Confirm details with coordinator.

Simple Process

  1. 1Submit this form
  2. 2Phone screening
  3. 3Visit Richmond site if eligible
  4. 4Begin participation

About This Acute Myocarditis Study in Richmond

This is a phase III, multi-center international, single blind randomized controlled trial to test the efficacy of pulsed intravenous (IV) methylprednisolone versus standard therapy on top of maximal support in patients with Acute myocarditis (AM).

Sponsor: Niguarda Hospital

Who Can Participate

Inclusion Criteria

Patients admitted to hospital for suspected AM
Age 18 years or older and below 70 years (18-69 years)
Acute HF with clinically suspected acute myocarditis based on an N-terminal pro-B-type natriuretic peptide (NT-proBNP) concentration of 1600 pg/mL or more or a B-type natriuretic peptide (BNP) concentration of 400 pg/mL or more;
Left ventricular ejection fraction (LVEF)\<41% and left ventricular end diastolic diameter (LV-EDD)\<56 mm (parasternal long-axis view) on echocardiogram;
Increased troponin (3x upper reference limit \[URL\]) at the time of randomization;
Clinical onset of cardiac symptoms within 3 weeks from randomization;
Excluded coronary artery disease by coronary angiogram in subjects ≥46 years of age, in case myocarditis is not histologically proven;
Randomization within 120 hours from hospital admission.

Exclusion Criteria

Known systemic autoimmune disorder or other conditions at the time of randomization where immunosuppression is assumed useful. Patients in whom a systemic autoimmune disorder will be diagnosed during hospitalization will be included in the study if randomized, including patients with a diagnosis of cardiac sarcoidosis or giant cell myocarditis (GCM). Both patients included in the corticosteroids-treatment arm or in the placebo-treatment arm can receive the standard immunosuppressive therapy used in the center since the diagnosis of a systemic autoimmune disorder, or cardiac sarcoidosis or GCM;
Patients already on oral/IV chronic corticosteroid therapy or other chronic immunosuppressive therapies (colchicine or nonsteroidal anti-inflammatory drugs \[NSAIDs\] are not considered immunosuppressive drugs);
Contraindication to corticosteroids, including allergies to this medication and its excipients;
Patients with persistent peripheral eosinophilia (persistent Eosinophil count \>7% of the leukocytes) or known hypereosinophilic syndrome at the time of randomization. Patients in whom eosinophilic myocarditis will be diagnosed on endomyocardial biopsy (EMB) will be included in the study if already randomized. Both patients included in the corticosteroids-treatment arm or in the placebo-treatment arm can receive the standard immunosuppressive therapy used in the center since the diagnosis;
Myocarditis associated with the ongoing administration of anti-cancer immune checkpoint inhibitor (ICI) agents;
Previously known chronic cardiac disease (i.e., previous cardiomyopathy) that does NOT include previous myocarditis if there is a functional recovery at the time of screening);
Evidence of active bacterial or fungal infectious disease (presence of fever or increased C-reactive protein are not considered exclusion criteria), or suspected bacterial/fungal infection associated with increased levels of procalcitonin (cut-off \>10 ng/mL), if the laboratory exam is available in the center;
Known chronic infective disease, such as HIV infection or tuberculosis;
out-of-hospital cardiac arrest;
t-MCS instituted more than 48 hours before randomization;
Patients clinically judged too sick to initiate t-MCS (i.e., irreversible multiorgan failure);
Echocardiographic presence of images suggestive of other cardiac diseases (i.e. endocarditis)
Participants involved in another clinical trial;
Pregnant women (known pregnancy) or POSITIVE human chorionic gonadotropin (HCG) test measures (urine/blood) for women of 18-50 years of age.
Any other significant disease with expected life expectancy \<12 months (i.e., evidence of irreversible severe brain injury) or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the trial, or may influence the result of the trial, or the participant's ability to participate in the trial.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Richmond?

Yes, this clinical trial (NCT05150704) has an active research site in Richmond, VA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Acute Myocarditis Treatment Options in Richmond, VA

If you're searching for acute myocarditis treatment options in Richmond, VA, this clinical trial (NCT05150704) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Richmond research site is actively enrolling participants for this phase 3 clinical trial. You'll receive care from experienced acute myocarditis specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all acute myocarditis clinical trials near you to find additional studies recruiting in your area.

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