RecruitingPHASE2INTERVENTIONAL

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

This study, called TaRGET, is looking into a heart condition known as Arrhythmogenic Cardiomyopathy (ACM). ACM can cause the heart muscle to scar, leading to irregular heartbeats. The study is testing a new drug, Tideglusib, to see if it can help improve the condition. Tideglusib works by targeting a specific pathway in the body. Half the participants will receive the active drug, and half will receive a placebo (a dummy pill). This is a 'double-blind' study, meaning neither the patient nor the doctor knows who is getting which treatment. It's hoped that this research will lead to better ways to manage ACM.

At a glance

Status

Recruiting

Phase

PHASE2

Sponsor

Hamilton Health Sciences Corporation

Enrolment target

120

Start

21 Mar 2025

Estimated completion

01 Jul 2027

Arrhythmogenic Cardiomyopathy Arrhythmogenic Right Ventricular Cardiomyopathy

What is this study about?

You might be reading this because you or someone you know has Arrhythmogenic Cardiomyopathy, often shortened to ACM. This is a heart condition where healthy heart muscle is replaced by scar tissue, particularly in the right side of the heart. This scarring can disrupt the heart's normal electrical signals, leading to irregular heartbeats, which can sometimes be serious.

While we've made great strides in understanding the genetic causes of ACM, we still don't fully understand exactly how the disease causes damage. This makes it challenging to develop specific treatments. Current approaches often involve using devices like implantable cardioverter defibrillators (ICDs) to prevent dangerous irregular heartbeats, but these don't address the underlying problem with the heart muscle itself.

This study is testing a new drug called Tideglusib. In earlier lab tests on fish and mice, a similar drug showed promise in preventing and even reversing some of the changes seen in ACM. This new study in humans aims to see if Tideglusib can have a similar positive effect by targeting a specific process in the heart cells. We hope this research will help us find better ways to treat ACM in the future.

Key takeaways

This study is for people with Arrhythmogenic Cardiomyopathy (ACM) with specific genetic types.
It's testing a new drug, Tideglusib, to see if it can improve the condition.
Participants will receive either the drug or a placebo, and nobody will know which one until after the study.
Regular health checks, including blood tests and heart monitoring, will be part of taking part.
The aim is to find better treatments for ACM.
Participation is voluntary, and you can withdraw at any time.

Who may be eligible?

To join this study, you would generally need to have a confirmed genetic link to ACM, either through certain gene changes (PKP2, DSG2, DSC2, DSP, JUP, or TMEM43-p.S358L). You would also need to have experienced a certain number of irregular heartbeats (more than 500 PVCs) over a 24-hour period, confirmed by a heart monitor.

There are also some reasons why you might not be able to join. For example, if you have very severe heart failure, certain liver problems, or have had recent changes to your heart medication, you might not be eligible. They will also check for other health conditions or medications that might interfere with the study drug, such as some anti-arrhythmic drugs, certain antibiotics, or drugs for blood thinning like warfarin. You also can't be pregnant or planning to become pregnant, and women of child-bearing age need to use effective contraception.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Do you have a genetically confirmed type of ACM?
Have you had more than 500 irregular heartbeats (PVCs) in 24 hours?
Are you 18 years old or older?
Are you not pregnant or actively trying to get pregnant?
Do you have certain liver or kidney conditions?
Are you currently on certain types of medications (your doctor can check)?

Answer every question to see your result.

What does participation involve?

If you decide to take part in this study, you will be given either the active drug, Tideglusib, or a placebo (a dummy pill). Neither you nor your study doctor will know which one you are taking until the end of the study. You will need to take the medication as instructed and attend regular appointments at the study clinic. These appointments will involve various health checks, including blood tests and heart monitoring, to see how the drug is affecting you and your heart condition. The study will last for a certain period, and you'll have follow-up appointments even after you stop taking the study medication. The total duration of your participation will be explained to you by the study team.

Potential risks and benefits

Taking part in any medical study has potential benefits and risks. You might benefit from the study drug improving your heart condition, but as it's a new treatment, there's also a chance it may not help you, or you might experience side effects. These side effects will be carefully monitored by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care. The study team will discuss all potential risks and benefits with you in detail before you make a decision.

Locations (17)

University of Calgary
Verified postcode
Calgary, Canada· Recruiting
University of British Columbia
Verified postcode
Vancouver, Canada· Recruiting
Victoria Cardiac Arrhythmia Trials Inc.
Verified postcode
Victoria, Canada· Recruiting
NL Health Services
Verified postcode
St. John's, Canada· Recruiting
Nova Scotia Health
Verified postcode
Halifax, Canada· Recruiting
Hamilton General Hospital
Verified postcode
Hamilton, Canada· Recruiting
Kingston General Hospital
Verified postcode
Kingston, Canada· Not yet recruiting
London Health Sciences Centre
Verified postcode
London, Canada· Recruiting
Newmarket Electrophysiologist Research Group 'NERG'
Verified postcode
Newmarket, Canada· Not yet recruiting
University of Ottawa Heart Institute
Verified postcode
Ottawa, Canada· Not yet recruiting
Heart Health Institute Research Inc
Verified postcode
Scarborough Village, Canada· Recruiting
Sunnybrook Health Sciences Centre
Verified postcode
Toronto, Canada· Not yet recruiting

Common questions

What is Arrhythmogenic Cardiomyopathy (ACM)?

ACM is a heart condition where healthy heart muscle is replaced by scar tissue, leading to irregular heartbeats.

What is Tideglusib?

Tideglusib is a new drug being tested in this study to see if it can help improve ACM by targeting specific processes in the heart.

What is a placebo?

A placebo is a 'dummy' pill that looks like the study drug but contains no active medication. It helps researchers understand the true effect of the drug.

Will I know if I'm getting the drug or the placebo?

No, this is a 'double-blind' study, meaning neither you nor your doctor will know until the study is over.

Can I leave the study at any time?

Yes, you have the right to withdraw from the study at any time without it affecting your medical care.

How to find out more

Jason Roberts, MD MAS

jason.roberts@phri.ca 905-521-2100 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.