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COMPLETED
NCT05180240
PHASE2

Impact of CardiolRx on Myocardial Recovery in Patients With Acute Myocarditis

Sponsor: Cardiol Therapeutics Inc.

View on ClinicalTrials.gov

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

Interventions

DRUG

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