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Glycogen Synthase Kinase-3 Inhibitor
Tideglusib for Arrhythmogenic Cardiomyopathy (TaRGET Trial)
Phase 2
Waitlist Available
Led By Jason D Roberts, MD MAS
Research Sponsored by Hamilton Health Sciences Corporation
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
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)
Be older than 18 years old
Must not have
Ventricular scar secondary to coronary artery disease
Serum creatinine > 150 micromole/L or creatinine clearance ≤ 60 mL/min (according to Cockcroft-Gault formula) at Screening
Timeline
Screening 3 weeks
Treatment Varies
Follow Up baseline and 6 months
Summary
This trial will test a potential new drug to treat a heart rhythm disorder.
Who is the study for?
This trial is for individuals with a genetic form of arrhythmogenic cardiomyopathy, which affects the heart muscle and can cause irregular heartbeats. Participants must meet specific criteria that will be detailed by the study organizers.
What is being tested?
The TaRGET study tests tideglusib, a drug aimed at inhibiting an enzyme involved in this type of heart disease, against a placebo. It's randomized and double-blind, meaning neither participants nor researchers know who gets the real drug or placebo.
What are the potential side effects?
Potential side effects of tideglusib are not specified here but generally could include issues related to its action on enzymes in the body. Placebo side effects are typically minimal since it contains no active medication.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have a specific genetic mutation linked to heart disease.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have heart scar tissue from blocked heart arteries.
Select...
My kidney function is reduced, with creatinine levels high or clearance low.
Select...
I am a male, not surgically sterile, and not using contraception while being sexually active with a woman who can bear children.
Select...
I have severe heart failure.
Select...
I have a long-term liver condition that could be harmful.
Select...
I haven't started, stopped, or changed the dose of a heart rhythm medication in the last 3 months.
Select...
I am not using strong medications like ketoconazole or ritonavir regularly.
Select...
I am not pregnant and use effective birth control.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ baseline and 6 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline and 6 months
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
PVC burden
Secondary study objectives
Implantable cardioverter-defibrillator (ICD) therapies
Sustained ventricular tachycardia (VT) events
Ventricular strain
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: TideglusibActive Control1 Intervention
Randomization to Tideglusib 1g po daily or matching placebo
Group II: PlaceboPlacebo Group1 Intervention
Randomization to matching placebo 1g po daily
Find a Location
Who is running the clinical trial?
Hearts in Rhythm Organization (HiRO)UNKNOWN
Hamilton Health Sciences CorporationLead Sponsor
377 Previous Clinical Trials
339,809 Total Patients Enrolled
Population Health Research InstituteOTHER
164 Previous Clinical Trials
718,394 Total Patients Enrolled
AMO PharmaUNKNOWN
Canadian Institutes of Health Research (CIHR)OTHER_GOV
1,392 Previous Clinical Trials
26,529,325 Total Patients Enrolled
Canadian SADSUNKNOWN
Stuart J Connolly, MDStudy ChairMcMaster University and Population Health Research Institute
Jason D Roberts, MD MASPrincipal InvestigatorMcMaster University and Population Health Research Institute
3 Previous Clinical Trials
1,000 Total Patients Enrolled