Testing Tideglusib against a placebo for arrhythmogenic cardiomyopathy
Official title: Targeted Therapy With Glycogen Synthase Kinase-3 Inhibition for Arrhythmogenic Cardiomyopathy
- Phase 2
- 2 groups
- Sites in Calgary, Vancouver and 12 more cities
- Recruiting
Interventions
- Medication
Tideglusib
Tideglusib 1g po daily
- Medication
Placebo
Matching placebo 1g po daily
Canadian Sites (17)
10 of 17 recruiting
- Recruiting
University of Calgary
Calgary, Alberta
- Recruiting
University of British Columbia
Vancouver, British Columbia
- Recruiting
Victoria Cardiac Arrhythmia Trials Inc.
Victoria, British Columbia
- Recruiting
NL Health Services
St. John's, Newfoundland and Labrador
- Recruiting
Nova Scotia Health
Halifax, Nova Scotia
- Recruiting
Hamilton General Hospital
Hamilton, Ontario
- Recruiting
London Health Sciences Centre
London, Ontario
- Recruiting
Heart Health Institute Research Inc
Scarborough Village, Ontario
- Recruiting
Montreal Heart Institute
Montreal, Quebec
- Recruiting
University Institute of Cardiology and Pneumology of Quebec
Québec, Quebec
- Not yet recruiting
Kingston General Hospital
Kingston, Ontario
- Not yet recruiting
Newmarket Electrophysiologist Research Group 'NERG'
Newmarket, Ontario
- Not yet recruiting
University of Ottawa Heart Institute
Ottawa, Ontario
- Not yet recruiting
Sunnybrook Health Sciences Centre
Toronto, Ontario
- Not yet recruiting
St. Michael's Hospital
Toronto, Ontario
- Not yet recruiting
McGill University Health Centre
Montreal, Quebec
- Not yet recruiting
Hopital du Sacré-Coeur de Montréal
Montreal, Quebec
Eligibility Criteria
See who this study is looking for18 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +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 baselineBaselineYour starting measurements, taken before treatment begins.Read more → screeningScreeningThe checks done before joining, to see whether a study fits.Read more → 7-day Holter monitor
- +Clinical ACM diagnosis or recognition of genetic carrier status for ≥ 6 months prior to screening
Exclusion
- −Hypersensitivity to tideglusib or any components of its formulation, including allergy to strawberry
- −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 screeningScreeningThe checks done before joining, to see whether a study fits.Read more →
- −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
- −Patients unwilling to provide informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → or comply with follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →
- −Concurrent use of drugs metabolized by CYP3A4 with a narrow therapeutic window e.g. warfarin and digoxin
- −Pregnant at time of enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → 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
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 2Phase 2A middle-stage study looking at what a treatment does and watching for side effects.Read more → — a middle-stage study in a few hundred people at most, looking at what the treatment does and watching for side effectsSide effectAn unwanted effect thought to be caused by the treatment itself.Read more →.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A, the comparison group, receives Tideglusib.
Registry label: A: Tideglusib
Group B, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Placebo.
Registry label: B: Placebo
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 120 people.
The study is currently expected to finish around July 2027.
The main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more → and 6 months.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
PVC burden — measured over BaselineBaselineYour starting measurements, taken before treatment begins.Read more → and 6 months.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06174220 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About TideglusibDrug
Tideglusib 1g po daily
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About PlaceboDrug
Matching placebo 1g po daily
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, the people giving the treatment, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: BaselineBaselineYour starting measurements, taken before treatment begins.Read more → and 6 months.
The study as a whole is currently expected to finish around 2027-07-01.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 120 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 14 locations, including: 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.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
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.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.