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New treatment option for Arrhythmogenic Cardiomyopathy
Official title Targeted Therapy With Glycogen Synthase Kinase-3 Inhibition for Arrhythmogenic Cardiomyopathy
ClinicalTrials.gov ID: NCT06174220
What this study is testing
What is Tideglusib?
Tideglusib is an investigational medicine, given as an once-daily pill taken by mouth, being studied as a potential treatment for arrhythmogenic cardiomyopathy.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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 β inhibitor, in genotype positive arrhythmogenic cardiomyopathy.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- A pathogenic or likely pathogenic desmosomal (PKP2, DSG2, DSC2, DSP, or JUP\ ) rare variant OR the TMEM43-p.S358L variant \ JUP carriers must be...
- 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
You likely can't join if
- 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...
See the full eligibility 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
- 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...
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Calgary, Alberta, Canada
- Vancouver, British Columbia, Canada
- Victoria, British Columbia, Canada
- St. John's, Newfoundland and Labrador, Canada
- Halifax, Nova Scotia, Canada
- Hamilton, Ontario, Canada
- Kingston, Ontario, Canada
- London, Ontario, Canada
- Newmarket, Ontario, Canada
- Ottawa, Ontario, Canada
- Scarborough Village, Ontario, Canada
- Toronto, Ontario, Canada
- Montreal, Quebec, Canada
- Québec, Quebec, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Calgary, Alberta, Canada; Vancouver, British Columbia, Canada; Victoria, British Columbia, Canada; St. John's, Newfoundland and Labrador, Canada; Halifax, Nova Scotia, Canada; Hamilton, Ontario, Canada and 8 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.