Impact of CardiolRx on Myocardial Recovery in Patients With Acute Myocarditis (NCT05180240) | Clinical Trial Compass
CompletedPhase 2
Impact of CardiolRx on Myocardial Recovery in Patients With Acute Myocarditis
United States109 participantsStarted 2022-06-22
Plain-language summary
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.
Who can participate
Age range18 Years – 75 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. Coronary artery disease (CAD) defined as a stenosis greater than 50% in a major epicardial coronary artery
✕. 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.
✕. Sepsis, defined as documented bacteremia at the time of presentation or other documented active infection.
✕. Severe left ventricular (LV) dysfunction requiring inotropic support, left ventricular assist device (LVAD) or other circulatory assist devices, or urgent need for transplantation
✕. Documented biopsy evidence of giant cell or eosinophilic myocarditis