Impact of CardiolRx on Myocardial Recovery in Patients With Acute Myocarditis

Completed · Phase 2 · Has a placebo group

Conditions studied: Acute Myocarditis

In brief

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.

Key facts

Study ID

NCT05180240

Run by

Cardiol Therapeutics Inc.

People needed

109

Starts

2022-07-28

Expected to finish

2025-02-04

Last updated by the study team

2026-06-17

Who can join

Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• Coronary artery disease (CAD) defined as a stenosis greater than 50% in a major epicardial coronary artery
• Severe valvular heart disease
• Inability to safely undergo CMR including administration of gadolinium
• 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.
• 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
• Prior history of sustained ventricular arrhythmia
• Acute coronary syndrome within 30 days
• Percutaneous coronary intervention within 30 days
• History of QT interval prolongation or QTc interval > 500 msec
• 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
• Inability or unwillingness to give informed consent
• Ongoing drug or alcohol abuse
• Women who are pregnant or breastfeeding
• Current diagnosis of cancer, with the exception of non-melanoma skin cancer
• 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

Where it is running

• MedStar Heart and Vascular Institute — Washington D.C., District of Columbia, United States
• Massachusetts General Hospital site — Boston, Massachusetts, United States
• Minneapolis Heart Institute Foundation — Minneapolis, Minnesota, United States
• Cleveland Clinic — Cleveland, Ohio, United States
• University of Pittsburgh Medical Center — Pittsburgh, Pennsylvania, United States
• Virginia Commonwealth University — Richmond, Virginia, United States
• Nupec-Orizonti — Belo Horizonte, Minas Gerais, Brazil
• PUC trials — Curitiba, Paraná, Brazil
• Complexo Hospitalar de Niterói — Niterói, Rio de Janeiro, Brazil
• Hospital Moinhos de Vento — Porto Alegre, Rio Grande do Sul, Brazil
• Hospital de Clínicas de Porto Alegre (HCPA) — Porto Alegre, Rio Grande do Sul, Brazil
• Hospital Nove de Julho — São Paulo, São Paulo, Brazil
• Hospital Felicio Rocho - Fundação Felice Rosso — Belo Horizonte, Brazil
• Hospital Angelina Caron — Campina Grande do Sul, Brazil
• Hospital São Lucas — Porto Alegre, Brazil
• Instituto D´Or de Pesquisa e Ensino — Rio de Janeiro, Brazil
• Hospital Pró-Cardíaco — Rio de Janeiro, Brazil
• Hospital Regional de São José — São José, Brazil
• Irmandade da Santa Casa de Misericórdia de São Paulo — São Paulo, Brazil
• Instituto do Coração - InCor — São Paulo, Brazil
• University of Alberta Hospital — Edmonton, Alberta, Canada
• McGill University Health Centre — Montreal, Quebec, Canada
• Hopital Louis Pradel Hospices Civils de Lyon — Bron, France
• CHU de Montpellier — Montpellier, France
• Centre Hospitalier Universitaire de Nîmes — Nîmes, France

Full record on ClinicalTrials.gov

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