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Impact of CardiolRx on Myocardial Recovery in Acute Myocarditis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT05180240
Recruitment Status : Not yet recruiting
First Posted : January 6, 2022
Last Update Posted : January 6, 2022
Sponsor:
Information provided by (Responsible Party):
Cardiol Therapeutics Inc.

Brief Summary:

Multi-center, double-blind, placebo-controlled, parallel group design. Patients with myocarditis within 90 days of onset of symptoms will be screened and, if eligible, randomized 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, 24-hour Holter assessments, the Kansas City Cardiomyopathy Questionnaire (KCCQ), the Columbia-Suicide Severity Rating Scale (C-SSRS) as well as physical exams and laboratory tests.

The primary outcome parameters are measured by CMR. Secondary outcomes include clinical endpoints and changes in inflammatory and biomarkers.


Condition or disease Intervention/treatment Phase
Acute Myocarditis Drug: CardiolRx Phase 2

Show Show detailed description

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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
Estimated Study Start Date : January 2022
Estimated Primary Completion Date : April 2023
Estimated Study Completion Date : April 2023

Resource links provided by the National Library of Medicine

Drug Information available for: Cannabidiol

Arm Intervention/treatment
Experimental: CardiolRx
  • Week 1 (p.m. dose of Day 1 to a.m. dose of Day 7): 2.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
  • Week 2 (p.m. dose of Day 7 to a.m. dose of Day 14): 5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
  • Week 3 (p.m. dose of Day 14 to a.m. dose of Day 21): 7.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
  • Week 4 to end of treatment period (p.m. dose of Day 21 to a.m. dose of last day of treatment period at week 12): 10 mg/kg of body weight b.i.d. CardiolRxTM or 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

Placebo Comparator: Placebo
  • Week 1 (p.m. dose of Day 1 to a.m. dose of Day 7): 2.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
  • Week 2 (p.m. dose of Day 7 to a.m. dose of Day 14): 5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
  • Week 3 (p.m. dose of Day 14 to a.m. dose of Day 21): 7.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo
  • Week 4 to end of treatment period (p.m. dose of Day 21 to a.m. dose of last day of treatment period at week 12): 10 mg/kg of body weight b.i.d. CardiolRxTM or 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




Primary Outcome Measures :
  1. Left-ventricular ejection fraction (LVEF) [ Time Frame: 12 weeks post randomization ]
    co-primary composite endpoint

  2. extracellular volume (ECV) [ Time Frame: 12 weeks post randomization ]
    co-primary

  3. Global longitudinal Strain (GLS) [ Time Frame: 12 weeks post randomization ]
    co-primary


Secondary Outcome Measures :
  1. Percentage of patients recovered [ Time Frame: From baseline to 12 weeks of treatment ]
    defined as LVEF ≥ 0.55 at 12 weeks of treatment

  2. 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)

  3. 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 (%)


  4. 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).


  5. 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)


  6. 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 in the degree of edema from baseline

  7. 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.


  8. 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.

  9. Time to resolution of clinical symptoms [ Time Frame: From baseline to 12 weeks of treatment ]
    chest pain, arrhythmias, shortness of breath

  10. 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.


  11. 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.


  12. 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.


  13. 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.


  14. Normalization of prognostically important ECG changes [ Time Frame: From baseline to 12 weeks of treatment ]
    Time to normalization of normalization of PR interval

  15. Normalization of prognostically important ECG changes [ Time Frame: From baseline to 12 weeks of treatment ]
    Time to normalization of normalization of QRS duration

  16. 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

  17. 24-hour Holter ECG monitoring abnormalities [ Time Frame: From baseline to 12 weeks of treatment ]
    Changes in abnormalities include Heart rate (average, minimum, maximum

  18. 24-hour Holter ECG monitoring abnormalities [ Time Frame: From baseline to 12 weeks of treatment ]
    Changes in abnormalities include Evidence of bradycardia heart block (defined as longest RR interval)

  19. 24-hour Holter ECG monitoring abnormalities [ Time Frame: From baseline to 12 weeks of treatment ]
    Changes in abnormalities include Number of extrasystoles (atrial and ventricular)

  20. 24-hour Holter ECG monitoring abnormalities [ Time Frame: From baseline to 12 weeks of treatment ]
    Changes in abnormalities include Number of 'runs' of extrasystoles and duration(s) of tachycardia, including periods of supraventricular



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Males and females aged between 18 and 75 years (inclusive)
  2. LVEF < 0.50
  3. Diagnosis consistent with acute myocarditis including:

    1. Clinical criteria (symptoms of chest pain, arrhythmia or shortness of breath, or history of viral-like illness), preferably followed by elevated troponin in the absence of hemodynamically significant CAD* (defined as a stenosis greater than 50% in a major epicardial coronary artery) within the previous 90 days PLUS
    2. CMR diagnosis: (Lake Louise Criterial) OR
    3. Endomyocardial biopsy showing either cellular inflammation and/or immunohistochemistry consistent with inflammation
  4. 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.
  5. 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:

  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) < 30 ml/min
  5. 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.
  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
  9. Acute coronary syndrome (ACS) within 30 days
  10. Percutaneous coronary intervention (PCI) within 30 days
  11. History of QT interval prolongation or QTc interval > 500 msec
  12. Treated with strong inducers CYP3A4 or CYP2C19
  13. Current participation in any research study involving investigational drugs or devices
  14. Inability or unwillingness to give informed consent
  15. Ongoing drug or alcohol abuse
  16. Women who are pregnant or breastfeeding
  17. Current diagnosis of cancer, with the exception of non-melanoma skin cancer
  18. Any factor, which would make it unlikely that the patient can comply with the study procedures.
  19. On any cannabinoid during the past month
  20. Body weight > 170 kg
  21. Showing suicidal tendency as per the C-SSRS, administered at screening

Information from the National Library of Medicine

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


Contacts
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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

Sponsors and Collaborators
Cardiol Therapeutics Inc.
Investigators
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Study Chair: Dennis McNamara, MD University of Pittsburgh
Publications:
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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: January 6, 2022
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Cardiol Therapeutics Inc.:
Pharmaceutically produced CBC
THC < 5ppm
Additional relevant MeSH terms:
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Myocarditis
Cardiomyopathies
Heart Diseases
Cardiovascular Diseases
Cannabidiol
Anticonvulsants