Evaluation of Cannabidiol on Myocardial Recovery in Patients with Acute Myocarditis: A Double-Blind, Placebo-Controlled Clinical Trial
- Trial ID
- 2024-514639-10-00
- Protocol
- Cardiol 100-002
- Sponsor
- Cardiol Therapeutics Inc.
Trial statistics
Diseases & Conditions
Objectives
The primary objective of this study is to evaluate the **efficacy** of CardiolRx, a cannabidiol-based solution, on **myocardial recovery** in patients diagnosed with **acute myocarditis**. This is clinically relevant as acute myocarditis can lead to significant cardiac dysfunction, and effective treatment options are limited. Additionally, the study aims to assess the **safety** of CardiolRx administration at the proposed doses in this patient population, ensuring that the treatment does not pose undue risk to participants.
Participants
The clinical trial involves a total of **65 participants** diagnosed with **acute myocarditis**. The study population includes both male and female subjects aged 18 years and older. Participants were selected based on specific clinical criteria, including symptoms such as chest pain, arrhythmia, or shortness of breath, and a confirmed diagnosis through elevated troponin levels, cardiac magnetic resonance imaging (CMR) using the Lake Louise Criteria, or endomyocardial biopsy indicating inflammation. The trial population is not restricted by general health status but includes individuals who are part of a vulnerable population. Lifestyle considerations such as diet and physical activity are not specified. Key inclusion criteria require participants to adhere to specific contraceptive measures if they are of childbearing potential, ensuring the safety and integrity of the study outcomes. The trial aims to evaluate the efficacy and safety of CardiolRx in promoting myocardial recovery in this patient group.
Plans and Procedures
The clinical trial is designed to evaluate the **efficacy** and safety of CardiolRx, a **cannabidiol** solution, in patients diagnosed with **acute myocarditis**. This study is a randomized, double-blind, placebo-controlled trial, which is categorized as a Phase 4 trial. The primary objective is to assess the effect of CardiolRx on myocardial recovery, specifically measuring the difference in extracellular volume and global longitudinal strain using cardiac magnetic resonance imaging at 12 weeks post-randomization. The trial is expected to conclude by January 31, 2025, with recruitment having commenced on March 30, 2023.
Participants will undergo a series of study visits, beginning with an inclusion visit to confirm eligibility based on criteria such as age, diagnosis of acute myocarditis, and contraceptive use. The inclusion visit will involve screening procedures to ensure participants meet the principal inclusion criteria, including clinical and diagnostic confirmation of acute myocarditis. Following randomization, participants will receive either CardiolRx or a placebo, administered orally, with a maximum daily dose of 1400 mg for a treatment period of up to 12 weeks.
Throughout the trial, participants will attend follow-up visits to monitor safety and efficacy outcomes. These visits will include assessments of cardiac function and any adverse events. The end-of-study visit will occur at the conclusion of the 12-week treatment period, where final evaluations will be conducted to determine the primary endpoints. Participant involvement is expected to last approximately 12 weeks, with conditions for early termination including withdrawal of consent, significant adverse events, or non-compliance with study procedures.
Treatment
The clinical trial involves the administration of **CardiolRx**, an experimental medication formulated as a **SOLUTION**. The active substance in CardiolRx is **CANNABIDIOL**, a chemical compound. The medication is produced by Cardiol Therapeutics Inc. and is classified as a synthetic pharmaceutical. CardiolRx is administered orally, with a maximum daily dose of 1400 mg. The total maximum dose over the treatment period is 105.35 grams. The treatment duration is set for a maximum of 12 weeks. The trial aims to evaluate the efficacy and safety of CardiolRx in patients with acute myocarditis.
In this double-blind, placebo-controlled trial, a placebo is used as the comparator treatment. The placebo is designed to match the experimental medication in appearance and administration route to ensure blinding. Participants are randomly assigned to receive either CardiolRx or the placebo. Compliance with the dosing schedule is monitored throughout the study to ensure adherence to the protocol. The primary objective is to assess the impact of CardiolRx on myocardial recovery, while also evaluating the safety profile of the medication in the specified patient population.
Efficacy
The efficacy of CardiolRx in the treatment of patients with **acute myocarditis** will be assessed through a double-blind, placebo-controlled trial. The primary endpoints for evaluating efficacy are the difference in the means of extra cellular volume (ECV) and global longitudinal strain (GLS). These parameters will be measured using cardiac magnetic resonance (CMR) imaging at 12 weeks post-randomization. The trial aims to determine the effect of CardiolRx on myocardial recovery by comparing these endpoints between the active treatment group and the placebo group. The assessment of these endpoints will provide insights into the potential benefits of CardiolRx in improving myocardial function in patients with acute myocarditis.
Inclusion and Exclusion Criteria
Inclusion Criteria
- Males and females 18 years of age or older
- 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, Appendix 17.4 of this protocol) within 10 days prior to randomization OR c). Endomyocardial biopsy 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 postmenopausal (at least 1 year absence of vaginal bleeding or spotting and confirmed by 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 contraceptives, oral contraceptives, patch contraceptives, implantable hormonal contraceptives, intrauterine device or system, surgical sterilization (hysterectomy, bilateral oophorectomy, and/or bilateral salpingectomy), tubal ligation/occlusion, vasectomized partner, or sexual abstinence, if this is the subject’s current practice. Periodic abstinence, i.e., calendar, symptothermal, or post-ovulation methods are not an acceptable form of contraception for this study. These methods of contraception also apply to female partners of male subjects.
Exclusion Criteria
- 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 [Protocol] 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
- Hypersensitivity to any component of CardiolRxTM (Cannabidiol Oil)
- Patients under legal protection (protection of the court, or in curatorship or guardianship)
- Current seizures or history of seizures
Trial Status by Country
| Country | Status | Start of Recruitment | Planned Patients |
|---|---|---|---|
 France | Not Recruiting | 30 Mar 2023 | 35 |
Sites & Investigators
Investigational Products
Details about the medicinal products being studied in this clinical trial.
| Product Name | Role in Trial | Formulation | Administration | Max Daily Dose | Treatment Duration | EU MP Number |
|---|---|---|---|---|---|---|
CardiolRx | Test | SOLUTION | ORAL | 1400 | 12 | PRD9565451 |