Impact of CardiolRx on Myocardial Recovery in Patients With Acute Myocarditis

About this trial

Last updated a year ago

Study ID

Cardiol 100-002

Status

Completed

Type

Interventional

Phase

Phase 2

Placebo

Accepting

18 to 75 Years

All Sexes

Trial Timing

Ended a year ago

What is this trial about?

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.

What are the participation requirements?

Inclusion Criteria

1. Males and females 18 years of age or older

2. Diagnosed 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 PLUS

2. CMR diagnosis (Lake Louise Criteria) within 10 days prior to randomization OR

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

3. 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.

4. 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. Prior history of sustained ventricular arrhythmia

10. Acute coronary syndrome within 30 days

11. Percutaneous coronary intervention within 30 days

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

13. Treated with strong inducers CYP3A4 or CYP2C19, as listed in Appendix 17.8

14. Treated with digoxin and/or type 1 or 3 antiarrhythmics

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

16. Inability or unwillingness to give informed consent

17. Ongoing drug or alcohol abuse

18. Women who are pregnant or breastfeeding

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

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

21. On any cannabinoid during the past month

22. Body weight > 170 kg

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