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Impact of CardiolRx on Myocardial Recovery in Patients With Acute Myocarditis
Sponsor: Cardiol Therapeutics Inc.
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.
Official title: Impact of CardiolRx on Myocardial Recovery in Acute Myocarditis. A Double-blind, Placebo-controlled Trial
Key Details
Gender
All
Age Range
18 Years - 75 Years
Study Type
INTERVENTIONAL
Enrollment
109
Start Date
2022-07-28
Completion Date
2025-02-04
Last Updated
2026-06-17
Healthy Volunteers
No
Conditions
Interventions
CardiolRx
Eligible patients will be randomized to receive CardiolRx or placebo. Intervention will be administered orally (via syringe) with food twice daily.
Locations (37)
MedStar Heart and Vascular Institute
Washington D.C., District of Columbia, United States
Massachusetts General Hospital site
Boston, Massachusetts, United States
Minneapolis Heart Institute Foundation
Minneapolis, Minnesota, United States
Cleveland Clinic
Cleveland, Ohio, United States
University of Pittsburgh Medical Center
Pittsburgh, Pennsylvania, United States
Virginia Commonwealth University
Richmond, Virginia, United States
Nupec-Orizonti
Belo Horizonte, Minas Gerais, Brazil
PUC trials
Curitiba, Paraná, Brazil
Complexo Hospitalar de Niterói
Niterói, Rio de Janeiro, Brazil
Hospital Moinhos de Vento
Porto Alegre, Rio Grande do Sul, Brazil
Hospital de Clínicas de Porto Alegre (HCPA)
Porto Alegre, Rio Grande do Sul, Brazil
Hospital Nove de Julho
São Paulo, São Paulo, Brazil
Hospital Felicio Rocho - Fundação Felice Rosso
Belo Horizonte, Brazil
Hospital Angelina Caron
Campina Grande do Sul, Brazil
Hospital São Lucas
Porto Alegre, Brazil
Instituto D´Or de Pesquisa e Ensino
Rio de Janeiro, Brazil
Hospital Pró-Cardíaco
Rio de Janeiro, Brazil
Hospital Regional de São José
São José, Brazil
Irmandade da Santa Casa de Misericórdia de São Paulo
São Paulo, Brazil
Instituto do Coração - InCor
São Paulo, Brazil
University of Alberta Hospital
Edmonton, Alberta, Canada
McGill University Health Centre
Montreal, Quebec, Canada
Hopital Louis Pradel Hospices Civils de Lyon
Bron, France
CHU de Montpellier
Montpellier, France
Centre Hospitalier Universitaire de Nîmes
Nîmes, France
Hôpital Lariboisière - Département de Cardiologie
Paris, France
Hopital Bichat Claude Bernard
Paris, France
Hôpital européen Georges-Pompidou
Paris, France
Institut de Cardiologie hopital Pitié Salpêtrière
Paris, France
Centre Hospitalier Universitaire de Poitiers
Poitiers, France
Hôpital Foch
Suresnes, France
Chu Rangueil
Toulouse, France
Barzilai Medical Center
Ashkelon, Israel
Shaare Zedek Medical Center
Jerusalem, Israel
Beilinson Hospital, Rabin medical Center
Petah Tikva, Israel
Tel Aviv Sourasky Medical Center (Ichilov)
Tel Aviv, Israel
Shamir Medical Center (Assaf Harofeh)
Zrifin, Israel