Impact of CardiolRx on Myocardial Recovery in Acute Myocarditis
Research type
Research Study
Full title
Impact of CardiolRx on Myocardial Recovery in Acute Myocarditis. A double-blind, placebo-controlled trial.
IRAS ID
1004804
Contact name
Dennis McNamara
Contact email
Sponsor organisation
Cardiol Therapeutics Inc.
Eudract number
2021-006637-19
Research summary
Myocarditis is an acute inflammatory condition of the myocardium or heart muscle. CardiolRxTM (cannabidiol solution) is known to have anti-inflammatory properties and is being investigated in this study to treat the underlying inflammatory process that involves the heart muscle. This study will be conduct at several medical centres. Half of the patients will receive active product and half will receive placebo product in a randomized fashion (similar to a coin toss). Neither the patient nor study staff know which patient is receiving which treatment.
Any patient entering the study must have been previously diagnosed with acute myocarditis. Patients can enter the study within 90 days after onset of symptoms. Patients will be asked to sign an informed consent form at this point. Assessments at the start of the study will include the following: Clinical assessment, including vital signs, ECG (including a 24-h ECG), and a chest x-ray; blood tests, and other tests related to the patient’s health. Frozen plasma will be retained for central analysis.
Study treatment needs to be taken with food and will be initiated in the evening of Day 1, after all baseline assessments have been completed and the patient has been randomized.
The product (either active or placebo) is taken orally twice a day as follows:
• Week 1: 2.5 mg/kg
• Week 2: 5 mg/kg
• Week 3: 7.5 mg/kg
• Week 4 to end of treatment period: 10 mg/kg
If a dose is not tolerated, it will be reduced to the previous tolerated dose.
Before each dose increase, the patient will be re-evaluated, including ECG monitoring.
Changes in dose will be dependent on medical review of the ECGs and the absence of abnormalities on those ECGs.
Final efficacy assessments will take place after 12 weeks of study treatment, and a final close out visit will occur a week after treatment was discontinued (Week 13).REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
22/EM/0082
Date of REC Opinion
1 Jun 2022
REC opinion
Further Information Unfavourable Opinion