Impact of CardiolRx on Myocardial Recovery in Acute Myocarditis

• Status: Not yet recruiting
• Trial end date: 2023-04-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Cardiol Therapeutics Inc.
• Treatments: Cannabidiol

Criteria

Inclusion Criteria:

1. Males and females aged between 18 and 75 years (inclusive)

2. LVEF < 0.50

3. Diagnosis consistent with acute myocarditis including:

1. Clinical criteria (symptoms of chest pain, arrhythmia or shortness of breath, or history of viral-like illness), preferably followed by elevated troponin in the absence of hemodynamically significant CAD* (defined as a stenosis greater than 50% in a major epicardial coronary artery) within the previous 90 days PLUS

2. CMR diagnosis: (Lake Louise Criterial) OR

3. Endomyocardial biopsy showing either cellular inflammation and/or immunohistochemistry consistent with inflammation

4. 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.

5. 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:

1. Coronary artery disease (CAD) defined as a stenosis greater than 50% in a major epicardial coronary artery

2. Severe valvular heart disease

3. Inability to safely undergo CMR including administration of gadolinium

4. Estimated glomerular filtration rate (eGFR) < 30 ml/min

5. 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.

6. Sepsis, defined as documented bacteremia at the time of presentation or other documented active infection.

7. Severe left ventricular (LV) dysfunction - requiring inotropic support, left ventricular assist device (LVAD) or other circulatory assist devices, or urgent need for transplantation

8. Documented biopsy evidence of giant cell or eosinophilic myocarditis

9. Acute coronary syndrome (ACS) within 30 days

10. Percutaneous coronary intervention (PCI) within 30 days

11. History of QT interval prolongation or QTc interval > 500 msec

12. Treated with strong inducers CYP3A4 or CYP2C19

13. Current participation in any research study involving investigational drugs or devices

14. Inability or unwillingness to give informed consent

15. Ongoing drug or alcohol abuse

16. Women who are pregnant or breastfeeding

17. Current diagnosis of cancer, with the exception of non-melanoma skin cancer

18. Any factor, which would make it unlikely that the patient can comply with the study procedures.

19. On any cannabinoid during the past month

20. Body weight > 170 kg

21. Showing suicidal tendency as per the C-SSRS, administered at screening