Recurrent Pericarditis Clinical Trial
Official title:
Impact of CardiolRxTM on Recurrent Pericarditis An Open Label Pilot Study (MAvERIC-Pilot Study)
Verified date | February 2024 |
Source | Cardiol Therapeutics Inc. |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Patients with recurrent pericarditis who are refractory or intolerant to current therapeutic management options or who require long-term administration of corticosteroids to control their disease are particularly challenging to manage. The pathogenesis of pericarditis involves the activation of the inflammasome. CardiolRxTM (a pure cannabidiol [CBD] solution) is known to have anti-inflammatory properties, including modulation of inflammasome signaling. This pilot study is to assess the tolerance and safety of CardiolRxTM during the resolution of pericarditis symptoms, assess improvement in objective measures of disease, and during the extension period, assess the feasibility of weaning concomitant background therapy including corticosteroids while taking CardiolRxTM.
Status | Active, not recruiting |
Enrollment | 25 |
Est. completion date | September 15, 2024 |
Est. primary completion date | June 15, 2024 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Male or female 18 years of age or older 2. Diagnosis of at least two episodes of recurrent pericarditis*, 3. At least 1 day with pericarditis pain =4 on the 11-point Numerical Rating Scale (NRS) within prior 7 days 4. One of; 1. C-Reactive Protein** (CRP) level =1.0 mg/dL within prior 7 days OR 2. Evidence of pericardial inflammation assessed by delayed pericardial hyperenhancement on cardiac magnetic resonance imaging (CMR) 5. Currently receiving non-steroidal anti-inflammatory drugs (NSAIDs) and/or colchicine and/or corticosteroids (in any combination) for treatment of pericarditis in stable doses 6. Male patients 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. 7. 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 y 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. - Diagnosis of pericarditis according to the 2015 European Society of Cardiology (ESC) Guidelines for the Diagnosis and Management of Pericardial Diseases (Adler et al. 2015): At least two of: 1. Pericarditic chest pain 2. Pericardial rub 3. New widespread ST-segment elevation or PR-segment depression according to electrocardiogram (ECG) findings 4. Pericardial effusion (new or worsening) - Conversion: 1 mg/dL CRP = 10 mg/L hs-CRP Exclusion Criteria: 1. Diagnosis of pericarditis that is secondary to specific prohibited etiologies, including tuberculosis (TB); neoplastic, purulent, or radiation etiologies; post-thoracic blunt trauma (e.g., motor vehicle accident); myocarditis 2. Estimated glomerular filtration rate (eGFR) <30 mL/min at screening 3. 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 4. Sepsis, defined as documented bacteremia at the time of screening or other documented active infection 5. Prior history of sustained ventricular arrhythmia 6. History of QT interval prolongation 7. QTc interval > 500 msec 8. Current participation in any research study involving investigational drugs or device 9. Inability or unwillingness to give informed consent 10. Ongoing drug or alcohol abuse 11. On any cannabinoid during the past month 12. Women who are pregnant or breastfeeding 13. Current diagnosis of cancer, with the exception of non-melanoma skin cancer 14. Any factor, which would make it unlikely that the patient can comply with the study procedures 15. Showing suicidal tendency as per the Columbia Suicide Severity Rating Scale (C-SSRS), administered at screening 16. On digoxin and/or type 1 or 3 antiarrhythmics 17. On immunosuppressive therapy with any of the following: 1. Rilonacept 2. Anakinra 3. Canakinumab 4. Methotrexate 5. Azathioprine 6. Cyclosporine 7. Intravenous immune globulin (IVIG) |
Country | Name | City | State |
---|---|---|---|
United States | Massachusetts General Hospital | Boston | Massachusetts |
United States | University of Vermont Medical Center | Burlington | Vermont |
United States | Cleveland Clinic | Cleveland | Ohio |
United States | Minneapolis Heart Institute Foundation | Minneapolis | Minnesota |
United States | Virginia Commonwealth University Health | Richmond | Virginia |
United States | Mayo Clinic | Rochester | Minnesota |
United States | Pima Heart and Vascular Clinical Research | Tucson | Arizona |
United States | MedStar Health Research Institute | Washington | District of Columbia |
Lead Sponsor | Collaborator |
---|---|
Cardiol Therapeutics Inc. |
United States,
Adler Y, Charron P, Imazio M, Badano L, Baron-Esquivias G, Bogaert J, Brucato A, Gueret P, Klingel K, Lionis C, Maisch B, Mayosi B, Pavie A, Ristic AD, Sabate Tenas M, Seferovic P, Swedberg K, Tomkowski W; ESC Scientific Document Group. 2015 ESC Guidelines for the diagnosis and management of pericardial diseases: The Task Force for the Diagnosis and Management of Pericardial Diseases of the European Society of Cardiology (ESC)Endorsed by: The European Association for Cardio-Thoracic Surgery (EACTS). Eur Heart J. 2015 Nov 7;36(42):2921-2964. doi: 10.1093/eurheartj/ehv318. Epub 2015 Aug 29. No abstract available. — View Citation
Klein AL, Imazio M, Cremer P, Brucato A, Abbate A, Fang F, Insalaco A, LeWinter M, Lewis BS, Lin D, Luis SA, Nicholls SJ, Pano A, Wheeler A, Paolini JF; RHAPSODY Investigators. Phase 3 Trial of Interleukin-1 Trap Rilonacept in Recurrent Pericarditis. N Engl J Med. 2021 Jan 7;384(1):31-41. doi: 10.1056/NEJMoa2027892. Epub 2020 Nov 16. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 11-point NRS pain score | change in patient-reported pericarditis pain using an 11-point NRS from baseline to 8 weeks | 8 weeks | |
Secondary | 11-point NRS pain score | Pain score using 11-point NRS after 26 weeks of treatment | 26 weeks | |
Secondary | Percentage of patients with normalized CRP levels | Percentage of patients with normalized CRP levels at 8 weeks (for patients with CRP =1.0 mg/dL at baseline) | 8 weeks | |
Secondary | Percentage of patients with pericarditis recurrence during the extension period (EP) | Percentage of patients with pericarditis recurrence during the extension period (EP) | 26 weeks | |
Secondary | Percentage of patients with normalized CRP levels | Percentage of patients with normalized CRP levels at 26 weeks (for patients with CRP = 1.0 mg/dL at baseline) | 26 weeks | |
Secondary | Time to normalized CRP levels | Time to CRP normalization for patients with CRP =1.0 mg/dL at baseline | Over 26 weeks | |
Secondary | CRP change from baseline | CRP change from baseline (%) | 26 weeks |
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