Status:
RECRUITING
Targeted Therapy With Glycogen Synthase Kinase-3 Inhibition for Arrhythmogenic Cardiomyopathy
Lead Sponsor:
Hamilton Health Sciences Corporation
Collaborating Sponsors:
Population Health Research Institute
Canadian Institutes of Health Research (CIHR)
Conditions:
Arrhythmogenic Cardiomyopathy
Arrhythmogenic Right Ventricular Cardiomyopathy
Eligibility:
All Genders
18+ years
Phase:
PHASE2
Brief Summary
The TaRGET study is a multi-centre, prospective, randomized, double-blind, placebo-controlled trial designed to evaluate the potential therapeutic efficacy of tideglusib, a glycogen synthase kinase-3 ...
Detailed Description
Arrhythmogenic cardiomyopathy (ACM) is a heritable form of structural heart disease characterized by myocardial fibrosis that confers vulnerability to malignant ventricular arrhythmias and sudden card...
Eligibility Criteria
Inclusion
- A pathogenic or likely pathogenic desmosomal (PKP2, DSG2, DSC2, DSP, or JUP\*) rare variant OR the TMEM43-p.S358L variant
- \*JUP carriers must be homozygous or compound heterozygous
- Mean ≥ 500 PVCs per 24 hours on a baseline screening 7-day Holter monitor
- Clinical ACM diagnosis or recognition of genetic carrier status for ≥ 6 months prior to screening
Exclusion
- NYHA class IV heart failure
- Ventricular scar secondary to coronary artery disease
- Initiation, cessation, or dose change of a Class I or III anti-arrhythmic drug in the 3 months prior to screening
- Any potentially harmful chronic liver disease
- ALT value \> 2X the upper limit of the normal reference range at Screening
- Total bilirubin value greater than the upper limit of the normal reference range at Screening, unless documented Gilbert's syndrome. For individuals with Gilbert's syndrome, total bilirubin value greater than 2-fold the upper limit of the normal reference range at Screening.
- A history of alcohol or illicit substance use disorders
- Regular and long-term use of strong CYP3A4 inhibitors, including clarithromycin, telithromycin, ketoconazole, itraconazole, posaconazole, nefazodone, idinavir and ritonavir
- Serum creatinine \> 150 micromole/L or creatinine clearance ≤ 60 mL/min (according to Cockcroft-Gault formula) at Screening
- Pregnant at time of enrollment and women of childbearing age who do not use a highly effective form of contraception
- Males, engaged in sexual relations with a female of child-bearing potential, not using an acceptable contraceptive method if not surgically sterile
- Patients unwilling to provide informed consent or comply with follow-up
- Hypersensitivity to tideglusib or any components of its formulation, including allergy to strawberry
- Concurrent use of drugs metabolized by CYP3A4 with a narrow therapeutic window e.g. warfarin and digoxin
Key Trial Info
Start Date :
March 21 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 1 2027
Estimated Enrollment :
120 Patients enrolled
Trial Details
Trial ID
NCT06174220
Start Date
March 21 2025
End Date
July 1 2027
Last Update
July 11 2025
Active Locations (17)
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1
Foothills Medical Centre
Calgary, Alberta, Canada, T2N 2T9
2
St. Paul's Hospital
Vancouver, British Columbia, Canada, V6Z 1Y6
3
Victoria Cardiac Arrhythmia Trials Inc.
Victoria, British Columbia, Canada, V8Z 0B9
4
Health Sciences Centre
St. John's, Newfoundland and Labrador, Canada, A1B 3V6