Impact of CardiolRx on Myocardial Recovery in Patients With Acute Myocarditis

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.

Timeline

Start

2022-07-28

Primary completion

2025-01-31

Completion

2025-02-04

Outcome

Sources disagree · no verdict is set; each source's reading is shown below

registry analysis (superiority test); CardiolRx vs Placebo; p = 0.2609; Mean Difference (Final Values) -0.87 (95% CI -2.40 to 0.66) reads as missed primary endpoint NCT05180240 ↗

registry analysis (superiority test); CardiolRx vs Placebo; p = 0.9021; Mean Difference (Final Values) -0.07 (95% CI -1.21 to 1.07) reads as missed primary endpoint NCT05180240 ↗

release “In the two primary endpoints—extracellular volume (“ECV”) and global longitudinal strain (“GLS”)—CardiolRx™ showed a notable improvement in ECV (p = 0.0538)” reads as missed primary endpoint cardiolrx.com ↗

release “with no significant difference observed in GLS in a population that had preserved left ventricular (“LV”) function at baseline.” reads as missed primary endpoint cardiolrx.com ↗

release “Topline results from our ARCHER trial demonstrated a significant reduction in LV mass—marking the first evidence of structural and remodeling improvement” reads as met primary endpoint cardiolrx.com ↗

Publications

• Background Lee WS, Erdelyi K, Matyas C, Mukhopadhyay P, Varga ZV, Liaudet L, Hasku G, Cihakova D, Mechoulam R, Pacher P. Cannabidiol Limits T Cell-Mediated Chronic Autoimmune Myocarditis: Implications to Autoimmune Disorders and Organ Transplantation. Mol Med. 2016 Sep;22:136-146. doi: 10.2119/molmed.2016.00007. Epub 2016 Jan 8.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Cannabidiol	Other / unclassified	10 mg/kg	—

Indications