CardiolRx for Myocarditis

(ARCHER Trial)

Recruiting at 44 trial locations

Overseen By Andrea B Parker, MSc, PhD

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Cardiol Therapeutics Inc.

Must not be taking: Cannabinoids, Digoxin, Antiarrhythmics

Disqualifiers: Coronary artery disease, Severe valvular heart disease, Sepsis, Cancer, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 2

Duration: 12 weeks

109 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

Dennis McNamara, MD

Principal Investigator

University of Pittsburgh

Eligibility Criteria

Adults diagnosed with acute myocarditis, confirmed by clinical symptoms and CMR or biopsy, can join this trial. Participants must agree to use contraception if necessary. Excluded are those with severe heart issues, recent heart procedures, drug/alcohol abuse, pregnant/breastfeeding women, certain other medical conditions or treatments.

Inclusion Criteria

I am using birth control or am post-menopausal.

I have been diagnosed with acute myocarditis, confirmed by specific heart tests or biopsy.

I am a man who will use double barrier contraception or have had a vasectomy.

Exclusion Criteria

I am not currently taking medication that strongly affects certain liver enzymes.

You have a history of a prolonged QT interval or a QTc interval longer than 500 milliseconds.

I need help for my heart to pump blood, like a device or medicine.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive CardiolRx or placebo for 12 weeks with dose escalation from 2.5 mg/kg to 10 mg/kg b.i.d.

12 weeks

Weekly visits for dose adjustment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

1 visit (in-person)

Treatment Details

Interventions

• CardiolRx

Trial Overview The trial is testing CardiolRx (a THC-free Cannabidiol) against a placebo in patients with myocarditis over a period of 12 weeks. It's double-blind and randomized: neither doctors nor patients know who gets the real medicine. They'll check heart health using scans and various tests.

Participant Groups

Group I: CardiolRx Experimental Treatment 1 Intervention

* Week 1 (p.m. dose of Day 1 to a.m. dose of Day 7): 2.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo * Week 2 (p.m. dose of Day 7 to a.m. dose of Day 14): 5 mg/kg of body weight b.i.d. CardiolRxTM or placebo * Week 3 (p.m. dose of Day 14 to a.m. dose of Day 21): 7.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo * Week 4 to end of treatment period (p.m. dose of Day 21 to a.m. dose of last day of treatment period at week 12): 10 mg/kg of body weight b.i.d. CardiolRxTM or placebo

Group II: Placebo Placebo Group 1 Intervention

* Week 1 (p.m. dose of Day 1 to a.m. dose of Day 7): 2.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo * Week 2 (p.m. dose of Day 7 to a.m. dose of Day 14): 5 mg/kg of body weight b.i.d. CardiolRxTM or placebo * Week 3 (p.m. dose of Day 14 to a.m. dose of Day 21): 7.5 mg/kg of body weight b.i.d. CardiolRxTM or placebo * Week 4 to end of treatment period (p.m. dose of Day 21 to a.m. dose of last day of treatment period at week 12): 10 mg/kg of body weight b.i.d. CardiolRxTM or placebo

Who Is Running the Clinical Trial?

Cardiol Therapeutics Inc.

Lead Sponsor

Trials

4

Recruited

330+