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Cardiol Therapeutics Receives Health Canada Approval for Phase II Clinical Trial of CardiolRx(TM) for Acute Myocarditis
Oakville, Ontario--(Newsfile Corp. - October 25, 2021) - Cardiol Therapeutics Inc. ( NASDAQ:...
About this update from Cardiol Therapeutics Inc. Class A
[{"type":"text","content":"Cardiol Therapeutics Receives Health Canada Approval for Phase II Clinical Trial of CardiolRx(TM) for Acute MyocarditisOakville, Ontario--(Newsfile Corp. - October 25, 2021) - Cardiol Therapeutics Inc. (NASDAQ: CRDL) (TSX: CRDL) (\"Cardiol\" or the \"Company\"), a clinical-stage biotechnology company focused on developing innovative anti-inflammatory therapies for the treatment of cardiovascular disease, is pleased to announce that it has received approval from Health Canada to proceed with the Company's Phase II, multi-center, double-blind, randomized, placebo-controlled trial designed to study the safety and tolerability of CardiolRx™ as well as its impact on myocardial recovery in patients presenting with acute myocarditis. The approval follows the U.S. Food and Drug Administration (FDA) providing clearance to proceed with the Company's Investigational New Drug (IND) application to commence this trial, as announced by the Company on August 24th, 2021. Myocarditis is an acute inflammatory condition of the myocardium, characterized by inflammation of the heart muscle, which may result in chest pain, impaired cardiac function, atrial and ventricular arrhythmias, and conduction disturbances. Although the symptoms are often mild, myocarditis remains an important cause of acute and fulminant heart failure and is a leading cause of sudden cardiac death in people less than 35 years old. In addition, some patients proceed to develop chronic dilated cardiomyopathy which continues to be the leading indication for cardiac transplantation. Although viral causes of myocarditis are the most common, myocarditis can result from a broad range of infections and can be caused by certain drugs, including chemo-therapeutic agents used to treat several common cancers. Myocarditis has also been described as a complication of COVID-19 and, more recently, has been reported as a rare complication associated with certain vaccines for COVID-19. Cardiol's acute myocarditis study is expected to enroll 100 patients at clinical centers in the United States, Canada, and Europe. The primary endpoints of the trial, which will be evaluated after 12 weeks of double-blind therapy, consist of the following cardiac magnetic resonance measures: left ventricular function (ejection fraction and longitudinal strain) and myocardial edema (extra-cellular volume), e...