RecruitingPHASE4INTERVENTIONAL

The STOP-MED CTRCD Trial

The STOP-MED CTRCD Trial is for cancer survivors who developed heart problems (cardiotoxicity) due to their cancer treatment, but whose heart function has now returned to normal. These individuals are currently taking medication for heart failure. The study wants to find out if it is safe for them to stop taking these heart medications. Often, people on these drugs experience side effects, have to remember multiple pills, and incur costs. If it's safe to stop these medicines, it could improve their quality of life. Participants will be carefully monitored to see if stopping or continuing their medication makes a difference to their heart health over several years.

At a glance

Status

Recruiting

Phase

PHASE4

Sponsor

Dinesh Thavendiranathan

Enrolment target

335

Start

04 Mar 2024

Estimated completion

01 Dec 2031

Heart Failure Cardiotoxicity Cardiac Toxicity Antineoplastics Toxicity Cancer

What is this study about?

When people have cancer treatment, sometimes it can affect their heart. This is called 'cancer therapy-related cardiac dysfunction' (CTRCD). It means the heart's ability to pump blood around the body isn't as good as it should be. This can happen to about 1 in 5 patients during or after their cancer treatment.

Usually, when this happens, doctors start medications to help protect the heart and prevent more serious problems like heart failure. The good news is that with early detection and treatment, most people (over 80%) see their heart function get back to normal. However, these heart medications often come with their own challenges. People might need to take many pills, deal with side effects like dizziness or tiredness, and there are financial costs involved. Because of this, cancer survivors whose hearts have recovered often wonder if they can safely stop taking these medicines.

Currently, doctors don't have enough scientific information to answer this important question. That's where this study comes in. Scientists want to know if it's safe to stop heart failure medications once the heart has fully recovered after cancer treatment. They will compare people who continue their medicines with those who safely stop them, carefully monitoring everyone's heart health to see which approach is better in the long run for people whose hearts have recovered.

Key takeaways

It's for cancer survivors whose hearts have recovered after cancer treatment.
Compares stopping heart medication vs. continuing it.
Primary goal is to see if stopping medication is safe.
Involves careful heart monitoring over 5 years.
Could help reduce daily pills and side effects for many people.
You can withdraw from the study at any time.

Who may be eligible?

This study is looking for adults aged 18 or older who have finished their cancer treatment at least six months ago (unless they are only on hormone therapy). You must have had cancer treatment that could affect the heart, such as certain chemotherapy drugs or targeted therapies.

Your heart must have been affected by your cancer treatment in the past, but crucially, your heart function must have returned to normal and be strong again (measured as having an LVEF of 55% or more). You should have been taking heart failure medication for your heart problem for at least six months, and you shouldn't have any current symptoms of heart failure.

There are also specific blood test results (NT-proBNP or BNP) that need to be within a normal range for your age and sex. You wouldn't be able to join if you have other reasons to continue taking heart medication, for example, if you have kidney disease that requires it.

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.

Are you 18 years old or older?
Did you complete cancer treatment (not just hormone therapy) over 6 months ago?
Was your heart affected by your past cancer treatment?
Is your heart function now considered normal by your doctor?
Are you currently taking heart medication because of your previous heart problem?
Do you have no other medical reasons (like kidney disease) requiring you to stay on heart medication?

Answer every question to see your result.

What does participation involve?

If you join this study, you'll first have special scans of your heart, called cardiac MRI scans. After these initial checks, you’ll be randomly placed into one of two groups: either you'll continue taking your heart medication as usual, or you'll safely stop taking it. This decision will be made by chance, like flipping a coin.

Throughout the study, your heart will be closely monitored. You'll have follow-up appointments and safety checks at 6-8 weeks, 6 months, 3 years, and 5 years after joining. You will also have follow-up cardiac MRI scans at 1 year and 5 years. The main goal is to see if your heart function remains healthy whether you stop or continue your medication. The study will last for a total of 5 years.

Potential risks and benefits

Taking part in this study could offer several potential benefits. If it's found safe to stop heart medication, it could mean fewer pills to take, fewer side effects like dizziness, and reduced financial costs for you in the long term. Regardless of your group, you'll receive careful monitoring of your heart health from medical specialists. However, there are potential risks too. If you are in the group that stops medication, there's a chance your heart function could worsen, although you will be closely monitored. You always have the right to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (14)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

University of California, Los Angeles
Verified postcode
Los Angeles, United States· Not yet recruiting
Brigham and Women's Hospital
Verified postcode
Boston, United States· Recruiting
Baker Heart and Diabetes Institute
Verified postcode
Melbourne, Australia· Recruiting
Cardio-Oncology Clinic, MAHI, University of Alberta Hospital
Verified postcode
Edmonton, Canada· Not yet recruiting
St. Boniface Hospital
Verified postcode
Winnipeg, Canada· Recruiting
Hamilton General Hospital
Verified postcode
Hamilton, Canada· Not yet recruiting
University of Ottawa Heart Institute
Verified postcode
Ottawa, Canada· Recruiting
St Michael's Hospital
Verified postcode
Toronto, Canada· Not yet recruiting
University Health Network
Verified postcode
Toronto, Canada· Recruiting
Maria Sklodowska-Curie National Research Institute of Oncology
Verified postcode
Warsaw, Poland· Not yet recruiting
La Paz University Hospital
Verified postcode
Madrid, Spain· Not yet recruiting
Barts Health NHS Trust, University College London
Verified postcode
London, United Kingdom· Recruiting

Common questions

What is 'heart failure medication'?

These are medicines given to help your heart pump blood more effectively, often used when your heart isn't working as well as it should.

What does 'CTRCD' mean?

CTRCD stands for Cancer Therapy-Related Cardiac Dysfunction. It means that your heart was affected by your cancer treatment.

How will I know if my heart function is 'normal'?

Doctors will use scans and blood tests to make sure your heart function meets the study's definition of normal before you can take part.

What is a 'cardiac MRI'?

It's a special type of scan that takes detailed pictures of your heart to see how well it's working.

Will I have to pay to be part of the study?

No, all study-related tests and appointments will be covered by the study.

How to find out more

Paaladinesh Thavendiranathan, MD

dinesh.thavendiranathan@uhn.ca 416-340-5326 Official trial record

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