Acute Myocarditis MedDRA version: 20.0 Level: LLT Classification code 10000932 Term: Acute myocarditis System Organ Class: 10007541 - Cardiac disorders
Conditions
Interventions
Product Name: CardiolRx
Product Code: CBD
Pharmaceutical Form: Oral solution
INN or Proposed INN: Cannabidiol
CAS Number: 13956-29-1
Current Sponsor code: CBD
Concentration unit: mg/ml milligram(s)/mi
Sponsors
Cardiol Therapeutics Inc.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Males and females 18 years of age or older 2. Diagnosed with acute myocarditis including: a) Clinical criteria (symptoms of chest pain, arrhythmia or shortness of breath, or history of viral-like illness), preferably followed by elevated troponin PLUS b) CMR diagnosis (Lake Louise Criteria) within 10 days prior to randomization OR c) 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 postmenopausal (at least 1 year absence of vaginal bleeding or spotting and confirmed by follicle stimulating hormone [FSH] =40 mIU/mL [or = 40 IU/L] if less than 2 y postmenopausal) or be surgically sterile. The following reliable methods of contraception are: parenteral Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 80 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 20
Exclusion criteria
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) 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the effect of CardiolRx on myocardial recovery in patients presenting with acute myocarditis and to demonstrate that administration of CardiolRx in the proposed doses in this patient population is safe.;Secondary Objective: To evaluate the effect of CardiolRxTM on myocardial recovery in patients presenting with acute myocarditis;Primary end point(s): The primary outcome of this study is comprised of two primary endpoints, i.e., the difference in the means of each: ECV and GLS, as measured byCMR at 12 weeks post randomization between the active and the placebo groups.;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - The secondary outcome of this study is the difference in the means of left-ventricular ejection fraction (LVEF), as measured by CMR at 12 weeks post randomization between the active and the placebo groups. Other Efficacy Outcomes: - Survival, free from major event (cardiac transplant, left-ventricular assist device (LVAD), hospitalization for heart failure (HF)) through 12 weeks post randomization - Change in CMR parameters from baseline to 12 weeks post randomization: LVEF, ECV, GLS, left ventricular end-diastolic volume (LVEDV), left ventricular end-systolic volume (LVESV), left atrial endsystolic volume (LAESV), LV mass, late gadolinium enhancement (LGE) imaging, degree of edema - Change in New York Heart Association (NYHA) classification from baseline to 12 weeks post randomization - Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) from baseline to 12 weeks post randomization - Time to resolution of clinical symptoms, including chest pain, arrhythmias, shortness of breath - Time to normalization of high sensitivity troponin (hs-troponin), Nterminal pro B-type naturetic peptide (NT-proBNP) and inflammatorymarkers: high sensitivity C reactive protein (hs-CRP), ferritin, tumour necrosis factor alpha (TNF-alpha), interleukin 1-beta (IL-1 beta), interleukin 6 (IL-6), interleukin 10 (IL-10), inerleukin 18 (IL-18) and endothelial markers: soluble vascular cell adhesion molecule-1 (sVCAM- 1), transforming growth factor beta (TGF-beta [beta 1 and beta 2]) - Change in hs-troponin, NT-proBNP and inflammatory markers (hs-CRP, ferritin, TNF-alpha, IL-1 beta, IL-6, IL-10, IL-18 and endothelial markers (sVCAM-1, TGF-beta [beta 1 and beta 2])) from baseline to week 12 post randomization - Time to normalization of electrocardiogram (ECG) abnormalities ;Timepoint(s) of evaluation of this end point: 12 weeks | — |
Countries
Brazil, Canada, France, Israel, United States
Contacts
Public ContactAndrea Parker
Cardiol Therapeutics Inc.
Outcome results
None listed