Impact of CardiolRx on Myocardial Recovery in Acute Myocarditis
Status: Recruiting
Conditions: Myocarditis
Location:
Massachusetts General HospitalMcGill University Health Care
MedStar Heart and Vascular Institute
Minneapolis Heart Institute Foundation
Palm Springs Community Health Centre
University of Alberta Hospital
University of Pennsylvania
University of Pittsburgh Medical Center
Virginia Commonwealth University
City/State:
Washington, DC
Miami Lakes, Florida
Boston, Massachusetts
Minneapolis, Minnesota
Cleveland, Ohio
Malvern, Pennsylvania
Pittsburgh, Pennsylvania
Richmond, Virginia
Edmonton, Alberta, Canada
Montreal, Quebec, Canada
Contact Information:
Dr. Mark Hofmeyer [email protected]
Dr. Yanely Pineiro
Dr. Daniel Zlotoff [email protected]
Dr. David Lin [email protected]
Dr. Pavan Bhat [email protected]
Dr. Victor Ferrari [email protected]
Dr. Jessica Huston [email protected]
Dr. Roshanak Markley [email protected]
Dr. Justin Ezekowitz [email protected]
Dr. Matthias Friedrich [email protected]
“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."
