Health TrialsbyHealthPanel

Targeted Therapy With Glycogen Synthase Kinase-3 Inhibition for Arrhythmogenic Cardiomyopathy

ConditionsArrhythmogenic CardiomyopathyArrhythmogenic Right Ventricular Cardiomyopathy
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorHamilton Health Sciences Corporation

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

A pathogenic or likely pathogenic desmosomal (PKP2, DSG2, DSC2, DSP, or JUP*) rare variant OR the TMEM43-p.S358L variant

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Tideglusib

    Drug

    Tideglusib 1g po daily

  • Placebo

    Drug

    Matching placebo 1g po daily

Treatment groups

120 Participants
are divided into 2 treatment groups
Group A: TideglusibActive comparator 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

PVC burden

Change in mean PVC count per 24 hours on 7-day Holter

Time frame
Baseline and 6 months

Secondary outcomes

1

Ventricular strain

Change in ventricular strain on echocardiography

Time frame
Baseline and 6 months
2

Implantable cardioverter-defibrillator (ICD) therapies

Number of ICD therapies (shock or anti-tachycardia pacing)

Time frame
Baseline and 6 months
3

Sustained ventricular tachycardia (VT) events

Number of sustained VT events (defined as symptomatic or duration \> 30 seconds and \> 100bpm)

Time frame
Baseline and 6 months

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Hamilton Health Sciences Corporation

Lead sponsor

Canadian Institutes of Health Research (CIHR)

Collaborator

Canadian SADS

Collaborator

AMO Pharma Limited

Collaborator

Hearts in Rhythm Organization (HiRO)

Collaborator

Population Health Research Institute

Collaborator

Source ClinicalTrials.gov
Apply now