Impact of CardiolRx on Myocardial Recovery in Patients With Acute Myocarditis

Trial details

Who runs it

Cardiol Therapeutics Inc.

Trial code

NCT05180240EU 2024-514639-10-00

Record updated

30 September 2026

Original description

Multi-center, double-blind, placebo-controlled, parallel group design. Patients with myocarditis will be screened and, if eligible, randomized within 10 days of the diagnostic CMR to CardiolRx or placebo.Read full original descriptionShow less

Impact of CardiolRx on Myocardial Recovery in Acute Myocarditis. A Double-blind, Placebo-controlled Trial

Multi-center, double-blind, placebo-controlled, parallel group design. Patients with myocarditis will be screened and, if eligible, randomized within 10 days of the diagnostic CMR to CardiolRx or placebo.

CardiolRx is pharmaceutically produced Cannabidiol and is free of tetrahydrocannabinol (THC<5 ppm). The treatment period is 12 weeks; a last follow-up visit is scheduled one week after the last treatment, 13 weeks after randomization. Study assessments include Cardiac Magnetic Resonance imaging (CMR), ECG monitoring, the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Columbia-Suicide Severity Rating Scale (C-SSRS) as well as physical exams and laboratory tests.

The primary and secondary outcome parameters are measured by CMR. Additional outcomes include clinical endpoints and changes in inflammatory and biomarkers.

Inclusion: 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.

Exclusion: 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.

ClinicalTrials.gov NCT05180240 · EU CTIS 2024-514639-10-00