Impact of CardiolRx on Myocardial Recovery in Acute Myocarditis
Status:
Not yet recruiting
Trial end date:
2023-04-01
Target enrollment:
Participant gender:
Summary
Multi-center, double-blind, placebo-controlled, parallel group design. Patients with
myocarditis within 90 days of onset of symptoms will be screened and, if eligible, randomized
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, 24-hour Holter assessments, the Kansas City
Cardiomyopathy Questionnaire (KCCQ), the Columbia-Suicide Severity Rating Scale (C-SSRS) as
well as physical exams and laboratory tests.
The primary outcome parameters are measured by CMR. Secondary outcomes include clinical
endpoints and changes in inflammatory and biomarkers.