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.
Trial Locations
Loading…
Loading trial locations…
Facility
City
State
Country
Status
Eligibility Criteria
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 di…
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
Picking one helps us show the most relevant trials first.
Your results are loading in the background — you can
change this any time from the results page.
Set your location to continue
Find My Trials uses your location to surface clinical trials near you.
Add your city or zip code to your profile and try again.