Targeted therapy for arrhythmogenic cardiomyopathy using tideglusib

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial evaluates the efficacy of tideglusib, a glycogen synthase kinase-3 β inhibitor, in patients with genotype positive arrhythmogenic cardiomyopathy (ACM). It is a multi-centre, prospective, randomized, double-blind, placebo-controlled trial designed to assess how this targeted therapy can address the underlying pathophysiology of ACM, which is characterized by myocardial fibrosis and a risk of sudden cardiac death. The study aims to recruit patients with specific genetic variants associated with ACM and monitor their response to treatment over time.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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

Where it's running

• University of Calgary
  Calgary, Alberta, Canada Recruiting
• University of British Columbia
  Vancouver, British Columbia, Canada Recruiting
• Victoria Cardiac Arrhythmia Trials Inc.
  Victoria, British Columbia, Canada Recruiting
• NL Health Services
  St. John's, Newfoundland and Labrador, Canada Recruiting
• Nova Scotia Health
  Halifax, Nova Scotia, Canada Recruiting
• Hamilton General Hospital
  Hamilton, Ontario, Canada Recruiting

Study contacts

• Principal investigator: Jason D Roberts, MD MAS — McMaster University and Population Health Research Institute
• Study coordinator: Jason Roberts, MD MAS
• Email: jason.roberts@phri.ca
• Phone: 905-521-2100

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• S-ICD Eligibility Over Time in Arrhythmogenic Cardiomyopathy

  This study checks whether adults with arrhythmogenic cardiomyopathy stay eligible for a subcutaneous ICD over 18 months.

  Recruiting University of Sao Paulo · São Paulo, São Paulo · NCT07849764

• FAPI PET/CT imaging in arrhythmogenic right ventricular cardiomyopathy

  This study will test whether a PET/CT scan using a 68Ga-DOTA-SA-FAPI tracer can detect active scarring in adults with ARVC and provide information beyond standard heart imaging.

  Recruiting Istanbul University - Cerrahpasa · Istanbul, Fatih · NCT07563660

• T1 mapping to characterize heart tissue in common heart diseases

  This project tests whether T1 mapping MRI scans, including dye-free native T1, can define normal and disease-specific heart tissue values for adults with various heart conditions.

  Recruiting Chinese Academy of Medical Sciences, Fuwai Hospital · Beijing, Beijing Municipality · NCT07354646

• Assessing patient characteristics and clinical course for those with PKP2-ACM

  This study looks at the experiences and health changes of people with PKP2-ACM over time to better understand the condition and its impact on their lives.

  Recruiting at 6 sites Lexeo Therapeutics · Redwood City, California and 5 other locations · NCT06976606

• Atorvastatin 80 mg to slow progression of arrhythmogenic cardiomyopathy

  This trial will try daily high-dose atorvastatin (80 mg) versus placebo in adults with arrhythmogenic cardiomyopathy to see if it prevents right ventricular functional decline and related electrical and structural worsening.

  Recruiting at 4 sites Phase 2 Centro Cardiologico Monzino · Pavia, PV and 4 other locations · NCT06922994

• Identifying patients with cardiomyopathy for potential heart transplantation

  This study is trying to find new ways to identify and understand cardiomyopathy in patients to better predict if they might need a heart transplant in the future.

  Recruiting IRCCS Azienda Ospedaliero-Universitaria di Bologna · Bologna, Emilia-Romagna/Bologna and 2 other locations · NCT06813443

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.