Targeted Therapy With Glycogen Synthase Kinase-3 Inhibition for Arrhythmogenic Cardiomyopathy

Phase 2

Not yet recruiting

• Conditions: Arrhythmogenic Cardiomyopathy; Arrhythmogenic Right Ventricular Cardiomyopathy

• Registration Number: NCT06174220
• Lead Sponsor: Hamilton Health Sciences Corporation

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2023-12-1
• Last Update Posted: 2 September 2024

Recruitment & Eligibility

• Status: Not yet recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Inclusion Criteria:<br><br> - A pathogenic or likely pathogenic desmosomal (PKP2, DSG2, DSC2, DSP, or JUP*) rare<br> variant OR the TMEM43-p.S358L variant<br><br> *JUP carriers must be homozygous or compound heterozygous<br><br> - Mean = 500 PVCs per 24 hours on a baseline screening 7-day Holter monitor<br><br> - Clinical ACM diagnosis or recognition of genetic carrier status for = 6 months prior<br> to screening<br><br>Exclusion Criteria:<br><br> - NYHA class IV heart failure<br><br> - Ventricular scar secondary to coronary artery disease<br><br> - Initiation, cessation, or dose change of a Class I or III anti-arrhythmic drug in<br> the 3 months prior to screening<br><br> - Any potentially harmful chronic liver disease<br><br> - ALT value > 2X the upper limit of the normal reference range at Screening<br><br> - Total bilirubin value greater than the upper limit of the normal reference range at<br> Screening, unless documented Gilbert's syndrome. For individuals with Gilbert's<br> syndrome, total bilirubin value greater than 2-fold the upper limit of the normal<br> reference range at Screening.<br><br> - A history of alcohol or illicit substance use disorders<br><br> - Regular and long-term use of strong CYP3A4 inhibitors, including clarithromycin,<br> telithromycin, ketoconazole, itraconazole, posaconazole, nefazodone, idinavir and<br> ritonavir<br><br> - Serum creatinine > 150 micromole/L or creatinine clearance = 60 mL/min (according to<br> Cockcroft-Gault formula) at Screening<br><br> - Pregnant at time of enrollment and women of childbearing age who do not use a highly<br> effective form of contraception<br><br> - Males, engaged in sexual relations with a female of child-bearing potential, not<br> using an acceptable contraceptive method if not surgically sterile<br><br> - Patients unwilling to provide informed consent or comply with follow-up<br><br> - Hypersensitivity to tideglusib or any components of its formulation, including<br> allergy to strawberry<br><br> - Concurrent use of drugs metabolized by CYP3A4 with a narrow therapeutic window e.g.<br> warfarin and digoxin

Exclusion Criteria

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
PVC burden

Secondary Outcome Measures

Name	Time	Method
Ventricular strain;Implantable cardioverter-defibrillator (ICD) therapies;Sustained ventricular tachycardia (VT) events