Active not recruitingNAINTERVENTIONAL

AMEND-CRT: Mechanical Dyssynchrony as Selection Criterion for CRT

This study, called AMEND-CRT, is investigating how to best choose patients for a heart treatment called Cardiac Resynchronization Therapy (CRT). Currently, many patients don't get the full benefit, which means they undergo a procedure that might not work for them. Researchers believe that looking closely at how the heart's pumping chambers move (called mechanical dyssynchrony) could help identify those who will respond well to CRT. The study will compare two groups: one chosen by current guidelines and another chosen by this new, more detailed heart muscle movement assessment. All patients will have a CRT device fitted, but in one group, it might be switched off if the heart muscle movement doesn't show a need for it. The goal is to improve treatment success and reduce unnecessary procedures.

At a glance

Status

Active not recruiting

Phase

Sponsor

Universitaire Ziekenhuizen KU Leuven

Enrolment target

500

Start

10 Dec 2020

Estimated completion

01 Dec 2030

Left Ventricular Dyssynchrony Heart Failure Cardiomyopathy, Dilated Cardiac Remodeling, Ventricular

What is this study about?

When your heart isn't pumping blood as well as it should, you might be diagnosed with a condition called heart failure. One way doctors can help some people with heart failure is with a special type of pacemaker called Cardiac Resynchronization Therapy, or CRT. This device helps the different parts of your heart's main pumping chamber (the left ventricle) beat in a more coordinated way, making it pump blood more efficiently.

However, the problem is that current ways of deciding who gets a CRT device aren't perfect. Around 30-40% of people who receive a CRT device don't actually get much benefit from it. This means they've had a procedure that might not have worked for them, which can be upsetting and also very costly for our healthcare system. Researchers think there's a better way to pick patients.

This study is testing a new approach. Doctors will use a special heart ultrasound (echocardiogram) to look at how the left ventricle's muscles move. They call this 'mechanical dyssynchrony.' The idea is that if the heart muscles aren't moving together properly, a CRT device might be very helpful. But if they're already moving quite well, the device might not offer much extra benefit. The study wants to see if using this detailed information can help doctors choose the right people for CRT more accurately, leading to better results and fewer unnecessary procedures.

Key takeaways

This study evaluates a new way to identify who benefits most from a special pacemaker (CRT).
It uses detailed heart scans to look at how heart muscles move.
All participants will receive a CRT device.
Some devices might be turned off based on scan results, to avoid unnecessary treatment.
The study aims to improve treatment success rates and reduce unhelpful procedures.
Participation involves follow-up for one year after the device implantation.

Who may be eligible?

To join this study, generally, you'd need to be at least 18 years old and have been diagnosed with heart failure where your main pumping chamber is struggling (your LVEF, or 'ejection fraction,' is quite low, and your heart chamber is a certain size). It's also important that your medical condition has been stable for at least a month, and if you've had blockages in your heart arteries, they should have been fully treated.

There are several reasons why you might not be able to join. For example, if your heart scans aren't clear, or if you have serious problems with your heart valves, certain lung conditions, or are on dialysis. You also can't be pregnant or breastfeeding. If your doctors believe you have less than a year to live, you wouldn't be included either.

Some specifics about pacemakers or other heart rhythm problems might also affect whether you can take part. The study needs to make sure they are comparing similar patients, so certain existing heart device settings or rhythm issues would mean you couldn't join.

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?
Have you been diagnosed with heart failure and a weakened pumping chamber?
Has your heart condition been stable for at least one month?
Are you able to provide written consent to take part?
Do you not have severe problems with your heart valves or certain lung conditions?
Are you not currently pregnant or breastfeeding?

Answer every question to see your result.

What does participation involve?

If you agree to take part in this study, you will first be randomly placed into one of two groups. Everyone in the study will have a CRT device implantation. One group will have their CRT device switched on as per current standard guidelines. The other group will also have a CRT device, but whether it's switched on or off will depend on the detailed scan of your heart's muscle movement. This means you might receive the device, but your doctors might decide to keep it turned off if the scans suggest it won't help.

After the device is fitted, you will have regular follow-up appointments over one year. During these appointments, doctors will check your heart using scans and assess your overall health and well-being. They will be looking at how your heart's pumping chamber changes in size and how you feel in general. No specific medication is prescribed by the study itself; your usual heart medications would continue as appropriate. The total duration of active participation for evaluation would be one year after your CRT device is implanted.

Potential risks and benefits

Taking part in any medical study has both potential benefits and risks. A potential benefit of this study is that it might help improve how we choose patients for CRT, leading to more successful treatments in the future. For you personally, if you are in the group getting the new assessment, it might mean you receive the most appropriate treatment for your heart, potentially avoiding an unnecessary activated device if it's unlikely to help. However, all surgery, including having a CRT device implanted, carries risks like infection or bleeding. In the experimental group, there's a chance your device might be turned off, and while experts believe this could be a better approach for some, it's part of what the study is designed to evaluate. You can always choose to withdraw from the study at any time without affecting your usual medical care.

Locations (24)

University Hospital Antwerp
Verified postcode
Antwerp, Belgium
ZNA Middelheim
Verified postcode
Antwerp, Belgium
AZ Sint-Jan Brugge
Verified postcode
Bruges, Belgium
AZ Maria Middelares
Verified postcode
Ghent, Belgium
Ghent University Hospital
Verified postcode
Ghent, Belgium
UZ Leuven
Verified postcode
Leuven, Belgium
AZ Damiaan
Verified postcode
Ostend, Belgium
AZ Delta
Verified postcode
Roeselare, Belgium
Dante Pazzanese Institute of Cardiology
Verified postcode
São Paulo, Brazil
CHRU Brest
Verified postcode
Brest, France
Groupements des hôpitaux de l'institut catholique de Lille
Verified postcode
Lille, France
CHU Rennes - Pontchaillou Hospital
Verified postcode
Rennes, France

Common questions

What is CRT?

CRT stands for Cardiac Resynchronization Therapy. It's a special type of pacemaker that helps the main pumping chamber of your heart beat in a more organised way to improve its pumping action.

What does 'mechanical dyssynchrony' mean?

It means the different parts of your heart's main pumping chamber aren't squeezing at the same time. This study is looking at whether checking this can help decide if a CRT device will be useful.

Will I definitely get a CRT if I join?

Yes, all patients in this study will have a CRT device implanted. However, whether it's switched on might depend on which study group you are in and the results of your heart scans.

Do I have to change my medicines?

The study itself doesn't ask you to change your existing heart medications. You would continue with the treatments your doctor usually prescribes for your heart condition.

How long will I be in the study?

You would be followed up for one year after your CRT device is implanted to see how you are doing and how your heart is responding to the treatment.