Impact of CardiolRx on Myocardial Recovery in Patients With Acute Myocarditis (ARCHER)
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ClinicalTrials.gov Identifier: NCT05180240 |
Recruitment Status :
Recruiting
First Posted : January 6, 2022
Last Update Posted : February 7, 2024
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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.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Myocarditis | Drug: CardiolRx | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 100 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | Multi-center, double-blind, randomized, placebo-controlled, parallel group design. 1:1 randomization |
Masking: | Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) |
Masking Description: | Placebo will match active study drug in color, odor, taste and appearance to assure proper blinding. |
Primary Purpose: | Treatment |
Official Title: | Impact of CardiolRx on Myocardial Recovery in Acute Myocarditis. A Double-blind, Placebo-controlled Trial |
Actual Study Start Date : | June 22, 2022 |
Estimated Primary Completion Date : | November 2024 |
Estimated Study Completion Date : | December 2024 |
Arm | Intervention/treatment |
---|---|
Experimental: CardiolRx
|
Drug: CardiolRx
Eligible patients will be randomized to receive CardiolRx or placebo. Intervention will be administered orally (via syringe) with food twice daily.
Other Name: Cannabidiol |
Placebo Comparator: Placebo
|
Drug: CardiolRx
Eligible patients will be randomized to receive CardiolRx or placebo. Intervention will be administered orally (via syringe) with food twice daily.
Other Name: Cannabidiol |
- extracellular volume (ECV) [ Time Frame: 12 weeks post randomization ]primary
- Global longitudinal Strain (GLS) [ Time Frame: 12 weeks post randomization ]primary
- Left-ventricular ejection fraction (LVEF) [ Time Frame: 12 weeks post randomization ]secondary endpoint
- Percentage of patients recovered [ Time Frame: From baseline to 12 weeks of treatment ]defined as LVEF ≥ 0.55 at 12 weeks of treatment
- Survival, free from major event [ Time Frame: 12 weeks post randomization ]Major event defined as cardiac transplant, left-ventricular assist device (LVAD), hospitalization for Heart failure (HF)
- Change in CMR parameters (%) [ Time Frame: From baseline to 12 weeks of treatment ]
Any change in CMR parameters from baseline to 12 weeks post randomization:
LVEF (%), ECV (%), GLS (%), LGE (%)
- Change in CMR parameters (mL/m2) [ Time Frame: From baseline to 12 weeks of treatment ]
Any change in CMR parameters from baseline to 12 weeks post randomization:
LVEDV (ml/m2), LVESV (ml/m2), LAESV (ml/m2).
- Change in CMR parameters (g/m2) [ Time Frame: From baseline to 12 weeks of treatment ]
Any change in CMR parameters from baseline to 12 weeks post randomization:
LV mass (g/m2)
- New York Heart Association classification (NYHA) [ Time Frame: From baseline to 12 weeks of treatment ]
New York Heart Association classification (NYHA) ranked in order of best to worse outcome from Class I (best) to Class IV (worst).
Record any change from baseline in percentage of patients in NYHA class IV/III/II class over the course of 12 weeks.
- Kansas City Cardiomyopathy Questionnaire (KCCQ) [ Time Frame: From baseline to 12 weeks of treatment ]Any changes from baseline KCCQ compared to after 12 weeks of treatment Where "No limits" is the best outcome and "Severely limited" is the worst outcome.
- Time to resolution of clinical symptoms [ Time Frame: From baseline to 12 weeks of treatment ]chest pain, arrhythmias, shortness of breath
- Changes in inflammatory and biomarker hs-troponin (nh/ml) [ Time Frame: From baseline to 12 weeks of treatment ]
Patients with myocarditis present with abnormal (very high) values in inflammatory and biomarkers.
The investigators are trying to determine if CardiolRx normalizes them faster than placebo.
- Changes in inflammatory and biomarkers NT-proBNP (pg/ml), TNF-alpha (pg/ml), IL-1 beta (pg/ml) and IL-6 (pg/ml) [ Time Frame: From baseline to 12 weeks of treatment ]
Patients with myocarditis present with abnormal (very high) values in inflammatory and biomarkers.
The investigators are trying to determine if CardiolRx normalizes them faster than placebo.
- Changes in inflammatory and biomarkers hs-CRP (mg/l), and ferritin (mg/l) [ Time Frame: From baseline to 12 weeks of treatment ]
Patients with myocarditis present with abnormal (very high) values in inflammatory and biomarkers.
The investigators are trying to determine if CardiolRx normalizes them faster than placebo.
- Changes in inflammatory and biomarker IL-10 (ng/ml) [ Time Frame: From baseline to 12 weeks of treatment ]
Patients with myocarditis present with abnormal (very high) values in inflammatory and biomarkers.
The investigators are trying to determine if CardiolRx normalizes them faster than placebo.
- Normalization of prognostically important ECG changes [ Time Frame: From baseline to 12 weeks of treatment ]Time to normalization of normalization of PR interval
- Normalization of prognostically important ECG changes [ Time Frame: From baseline to 12 weeks of treatment ]Time to normalization of normalization of QRS duration
- Normalization of prognostically important ECG changes [ Time Frame: From baseline to 12 weeks of treatment ]Time to normalization of normalization of ST/T wave changes
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 75 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Males and females 18 years of age or older
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Diagnosed with acute myocarditis including:
- Clinical criteria (symptoms of chest pain, arrhythmia or shortness of breath, or history of viral-like illness), preferably followed by elevated troponin PLUS
- CMR diagnosis (Lake Louise Criteria) within 10 days prior to randomization OR
- Endomyocardial biopsy (EMB) 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 post- menopausal.
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 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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05180240
Contact: Andrea B Parker, MSc, PhD | +1 289.910.0862 | andrea.parker@cardiolrx.com | |
Contact: Andrew Hamer, MD | +1 289.910.0380 | andrew.hamer@cardiolrx.com |
Study Chair: | Dennis McNamara, MD | University of Pittsburgh |
Responsible Party: | Cardiol Therapeutics Inc. |
ClinicalTrials.gov Identifier: | NCT05180240 |
Other Study ID Numbers: |
Cardiol 100-002 |
First Posted: | January 6, 2022 Key Record Dates |
Last Update Posted: | February 7, 2024 |
Last Verified: | February 2024 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Pharmaceutically produced CBC THC < 5ppm |
Myocarditis Cardiomyopathies Heart Diseases |
Cardiovascular Diseases Cannabidiol Anticonvulsants |