Impact of CardiolRxTM on Myocardial Recovery in Patients with Acute MyocarditisA double-blind, placebo-controlled trial

Phase 1

• Conditions: Acute Myocarditis; MedDRA version: 20.0Level: LLTClassification code 10000932Term: Acute myocarditisSystem Organ Class: 10007541 - Cardiac disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2021-006637-19-FR
• Lead Sponsor: Cardiol Therapeutics Inc.

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-07-12
• Last Update Posted: 15 July 2024

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 100

Inclusion Criteria

1. Males and females 18 years of age or older
2. Diagnosed with acute myocarditis including:
a) Clinical criteria (symptoms of chest pain, arrhythmia or shortness of
breath, or history of viral-like illness), preferably followed by elevated
troponin PLUS
b) CMR diagnosis (Lake Louise Criteria) within 10 days prior to
randomization OR
c) Endomyocardial biopsy (EMB) showing either cellular inflammation
and/or immunohistochemistry consistent with inflammation.
3. 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.
4. 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 postmenopausal (at least 1 year absence of vaginal bleeding or
spotting and confirmed by follicle stimulating hormone [FSH] =40
mIU/mL [or = 40 IU/L] if less than 2 y postmenopausal) or be surgically
sterile. The following reliable methods of contraception are: parenteral
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 80
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 20

Exclusion Criteria

1. Coronary artery disease (CAD) defined as a stenosis greater than
50% in a major epicardial coronary artery
2. Severe valvular heart disease
3. Inability to safely undergo CMR including administration of
gadolinium
4. Estimated glomerular filtration rate (eGFR) < 30 ml/min
5. 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.
6. Sepsis, defined as documented bacteremia at the time of
presentation or other documented active infection.
7. Severe left ventricular (LV) dysfunction - requiring inotropic
support, left ventricular assist device (LVAD) or other circulatory
assist devices, or urgent need for transplantation
8. Documented biopsy evidence of giant cell or eosinophilic
myocarditis

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the effect of CardiolRx on myocardial recovery in patients presenting with acute myocarditis and to demonstrate that administration of CardiolRx in the proposed doses in this patient population is safe.;Secondary Objective: To evaluate the effect of CardiolRxTM on myocardial recovery in patients<br>presenting with acute myocarditis;Primary end point(s): The primary outcome of this study is comprised of two primary<br>endpoints, i.e., the difference in the means of each: ECV and GLS, as<br>measured byCMR at 12 weeks post randomization between the active<br>and the placebo groups.;Timepoint(s) of evaluation of this end point: 12 weeks