Impact of CardiolRx on Myocardial Recovery in Patients With Acute Myocarditis

Ki vehet részt

• Males and females 18 years of age or older
• Diagnosed with acute myocarditis including:; Clinical criteria (symptoms of chest pain, arrhythmia or shortness of breath, or history of viral-like illness), preferably followed by elevated troponin PLUS; CMR diagnosis (Lake Louise Criteria) within 10 days prior to randomization OR; Endomyocardial biopsy (EMB) showing either cellular inflammation and/or immunohistochemistry consistent with inflammation
• Male subjects with partners of childbearing potential who have had a vasectomy or are willing to use double barrier contraception methods during the conduct of the study and for 2 months after the last dose of study drug
• Women of childbearing potential willing to use an acceptable method of contraception starting with study drug administration and for a minimum of 2 months after study completion. Otherwise, women must be post- menopausal

Ki nem vehet részt

• Severe left ventricular (LV) dysfunction requiring inotropic support, left ventricular assist device (LVAD) or other circulatory assist devices, or urgent need for transplantation
• Prior history of sustained ventricular arrhythmia
• Treated with strong inducers CYP3A4 or CYP2C19, as listed in Appendix 17.8
• Treated with digoxin and/or type 1 or 3 antiarrhythmics
• Current participation in any research study involving investigational drugs or devices
• Ongoing drug or alcohol abuse
• Coronary artery disease (CAD) defined as a stenosis greater than 50% in a major epicardial coronary artery
• Severe valvular heart disease
• Sepsis, defined as documented bacteremia at the time of presentation or other documented active infection
• Acute coronary syndrome within 30 days
• Current diagnosis of cancer, with the exception of non-melanoma skin cancer
• Estimated glomerular filtration rate (eGFR) < 30 ml/min
• Elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 5 times the upper limit of normal (ULN) or ALT or AST >3x ULN plus bilirubin >2x ULN
• History of QT interval prolongation or QTc interval > 500 msec
• Inability to safely undergo CMR including administration of gadolinium
• Documented biopsy evidence of giant cell or eosinophilic myocarditis
• Percutaneous coronary intervention within 30 days
• Inability or unwillingness to give informed consent
• Women who are pregnant or breastfeeding
• Any factor, which would make it unlikely that the patient can comply with the study procedures
• On any cannabinoid during the past month
• Body weight > 170 kg
• Showing suicidal tendency as per the C-SSRS, administered at screening