Impact of CardiolRx on Myocardial Recovery in Patients With Acute Myocarditis

NCT05180240 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: Cardiol 100-002
• Study Type: interventional
• Target: 109
• Locations: 5 countries
• Sites: 37

Brief Summary

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.

Conditions

Acute Myocarditis

Keywords

Pharmaceutically produced CBC; THC < 5ppm

Outcome Measures

Primary Outcomes (2)

• extracellular volume (ECV)

  primary

  12 weeks post randomization

• Global longitudinal Strain (GLS)

  primary

  12 weeks post randomization

Secondary Outcomes (1)

• Left-ventricular ejection fraction (LVEF)

  12 weeks post randomization

Other Outcomes (15)

• Percentage of patients recovered

  From baseline to 12 weeks of treatment

• Survival, free from major event

  12 weeks post randomization

• Change in CMR parameters (%)

  From baseline to 12 weeks of treatment

Study Arms (2)

CardiolRx

EXPERIMENTAL

* 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

Placebo

PLACEBO COMPARATOR

* 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

Interventions

CardiolRx DRUG

Eligible patients will be randomized to receive CardiolRx or placebo. Intervention will be administered orally (via syringe) with food twice daily.

Also known as: Cannabidiol

CardiolRx; Placebo

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Males and females 18 years of age or older
• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Cardiol Therapeutics Inc.: lead

Study Sites (37)

MedStar Heart and Vascular Institute

Washington D.C., District of Columbia, 20010, United States

Location

Massachusetts General Hospital site

Boston, Massachusetts, 02114, United States

Location

Minneapolis Heart Institute Foundation

Minneapolis, Minnesota, 55407, United States

Location

Cleveland Clinic

Cleveland, Ohio, 44195, United States

Location

University of Pittsburgh Medical Center

Pittsburgh, Pennsylvania, 15213, United States

Location

Virginia Commonwealth University

Richmond, Virginia, 23298, United States

Location

Nupec-Orizonti

Belo Horizonte, Minas Gerais, 30210090, Brazil

Location

PUC trials

Curitiba, Paraná, 80230-130, Brazil

Location

Complexo Hospitalar de Niterói

Niterói, Rio de Janeiro, 24020-096, Brazil

Location

Hospital Moinhos de Vento

Porto Alegre, Rio Grande do Sul, 90035-001, Brazil

Location

Hospital de Clínicas de Porto Alegre (HCPA)

Porto Alegre, Rio Grande do Sul, 90035-003, Brazil

Location

Hospital Nove de Julho

São Paulo, São Paulo, 01409-002, Brazil

Location

Hospital Felicio Rocho - Fundação Felice Rosso

Belo Horizonte, Brazil

Location

Hospital Angelina Caron

Campina Grande do Sul, Brazil

Location

Hospital São Lucas

Porto Alegre, Brazil

Location

Instituto D´Or de Pesquisa e Ensino

Rio de Janeiro, 22281-100, Brazil

Location

Hospital Pró-Cardíaco

Rio de Janeiro, Brazil

Location

Hospital Regional de São José

São José, Brazil

Location

Irmandade da Santa Casa de Misericórdia de São Paulo

São Paulo, 01223-001, Brazil

Location

Instituto do Coração - InCor

São Paulo, Brazil

Location

University of Alberta Hospital

Edmonton, Alberta, T6G2B7, Canada

Location

McGill University Health Centre

Montreal, Quebec, H4A 3J1, Canada

Location

Hopital Louis Pradel Hospices Civils de Lyon

Bron, 69500, France

Location

CHU de Montpellier

Montpellier, 34295, France

Location

Centre Hospitalier Universitaire de Nîmes

Nîmes, 30029, France

Location

Hôpital Lariboisière - Département de Cardiologie

Paris, 75475, France

Location

Hopital Bichat Claude Bernard

Paris, France

Location

Hôpital européen Georges-Pompidou

Paris, France

Location

Institut de Cardiologie hopital Pitié Salpêtrière

Paris, France

Location

Centre Hospitalier Universitaire de Poitiers

Poitiers, France

Location

Hôpital Foch

Suresnes, 92150, France

Location

Chu Rangueil

Toulouse, France

Location

Barzilai Medical Center

Ashkelon, 7830604, Israel

Location

Shaare Zedek Medical Center

Jerusalem, 9103102, Israel

Location

Beilinson Hospital, Rabin medical Center

Petah Tikva, 4941492, Israel

Location

Tel Aviv Sourasky Medical Center (Ichilov)

Tel Aviv, 6423906, Israel

Location

Shamir Medical Center (Assaf Harofeh)

Zrifin, 70300, Israel

Location

Related Publications (1)

• Lee WS, Erdelyi K, Matyas C, Mukhopadhyay P, Varga ZV, Liaudet L, Hasku G, Cihakova D, Mechoulam R, Pacher P. Cannabidiol Limits T Cell-Mediated Chronic Autoimmune Myocarditis: Implications to Autoimmune Disorders and Organ Transplantation. Mol Med. 2016 Sep;22:136-146. doi: 10.2119/molmed.2016.00007. Epub 2016 Jan 8.

  PMID: 26772776 BACKGROUND

MeSH Terms

Interventions

Cannabidiol

Intervention Hierarchy (Ancestors)

Cannabinoids; Terpenes; Hydrocarbons; Organic Chemicals

Study Officials

• Dennis McNamara, MD

  University of Pittsburgh

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Placebo will match active study drug in color, odor, taste and appearance to assure proper blinding.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Multi-center, double-blind, randomized, placebo-controlled, parallel group design. 1:1 randomization

Study Record Dates

• First Submitted: September 25, 2021
• First Posted: January 6, 2022
• Study Start: June 22, 2022
• Primary Completion: January 31, 2025
• Study Completion: February 4, 2025
• Last Updated: March 12, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

FR (10); US (6); IL (5); BR (14); CA (2)