RecruitingNAINTERVENTIONAL

Prevention Of Sudden Cardiac Death After Myocardial Infarction by Defibrillator Implantation

If you've had a heart attack and your heart is now weaker, you might be at risk of sudden cardiac death. In the past, doctors often implanted a device called a defibrillator to help prevent this. However, heart medicines have improved a lot since then, and we now wonder if these new medicines are just as effective on their own. This study aims to find out if taking the best available medicines for a weakened heart is as good as, or even better than, having a defibrillator fitted, for preventing sudden death after a heart attack. The results will help doctors make better decisions about care for people like you.

At a glance

Status

Recruiting

Phase

Sponsor

Charite University, Berlin, Germany

Enrolment target

3,595

Start

16 Nov 2023

Estimated completion

30 Nov 2027

Sudden Cardiac Death Myocardial Infarction

What is this study about?

Imagine your heart has been through a lot, perhaps after a heart attack. Sometimes, this can leave your heart muscle weaker, putting you at a higher risk of its electrical system going haywire, which can cause sudden death. In the past, a common solution was to implant a small device called a defibrillator, which acts like a tiny paramedic inside your chest, ready to deliver an electric shock if your heart beats dangerously fast.

However, medical care has come a long way. We now have much better medicines that can help strengthen your heart and reduce the risk of these dangerous heart rhythms. This means that the need for a defibrillator might not be as clear-cut as it once was. These devices, while life-saving for some, also come with their own risks and can be quite expensive.

So, this new study wants to re-evaluate the situation. We want to compare what happens when people who have had a heart attack and have a weakened heart receive the very best modern medications, either with or without a defibrillator. Our main goal is to see if taking just the excellent medicines available today is as safe and effective as having a defibrillator fitted, in terms of helping people live longer after a heart attack. This research will help doctors and patients make informed choices about treatment for similar conditions in the future.

Key takeaways

This study compares defibrillators vs. modern medicines for heart attack survivors.
It aims to see if current medicines alone are as good as a defibrillator for preventing sudden death.
People with weakened hearts after a heart attack and on existing best medicines are eligible.
Participation involves ongoing monitoring and possibly a defibrillator implant.
The goal is to improve future care for people with weak hearts after a heart attack.

Who may be eligible?

This study is looking for adults aged 18 or older who have had a heart attack at least three months ago. Your heart must show signs of being weaker than normal (doctors call this a reduced LVEF of 35% or less), and you must be experiencing symptoms of heart failure, like breathlessness or tiredness, which are classified as NYHA Class II or III. Importantly, you should already be taking the best possible medicines for your heart condition for at least three months.

There are also some reasons why you wouldn't be able to join. For example, if you already have a pacemaker or defibrillator, or if doctors have recommended a defibrillator or another device called a CRT for specific, urgent reasons. If you've recently had major heart surgery or a procedure within the last six weeks, or if you're on a waiting list for a heart transplant, you wouldn't be eligible. Also, if another illness means your life expectancy is less than a year, you cannot take part.

Quick self-check

Are you 18 years old or older?
Have you had a heart attack at least 3 months ago?
Is your heart weaker than normal (LVEF 35% or less)?
Are you already taking the best available medicines for your heart condition for at least 3 months?
Do you have symptoms like breathlessness or tiredness from your heart condition?
Have you never had a pacemaker or defibrillator implanted before?

This is a guide only — the research team will confirm whether you can take part.

What does participation involve?

If you decide to take part, you would first have a thorough check-up to make sure you fit the study requirements. Then, you would be randomly assigned to one of two groups: either you would continue with your optimal medical therapy (OMT) as usual, or you would continue with OMT and also have a defibrillator implanted. You would have regular check-ups, potentially including heart scans, blood tests, and discussions about your symptoms and medicines. The study will track your health over time to compare the outcomes between the two groups. The total duration of your participation would depend on the study design, but generally, these types of studies involve long-term follow-up.

Potential risks and benefits

Taking part in any study has potential benefits and risks. You might benefit from closer monitoring of your health and access to the latest medical care. However, if you are in the defibrillator group, there are risks associated with the implantation procedure itself, such as infection or bleeding, and the device can sometimes deliver unnecessary shocks. The study aims to determine if these risks outweigh the benefits compared to leading-edge medical treatment alone. You are free to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (86)

Landeskrankenhaus Feldkirch
Feldkirch, Austria· Recruiting
LKH Universitätsklinikum Graz
Graz, Austria· Recruiting
Tirol Kliniken - Universitätsklinik Innsbruck
Innsbruck, Austria· Recruiting
Klinikum Klagenfurt am Wörthersee
Klagenfurt, Austria· Recruiting
Ordensklinikum Linz GmbH Elisabethinen
Linz, Austria· Recruiting
Landeskrankenhaus Salzburg - Universitätsklinikum der PMU
Salzburg, Austria· Recruiting
Universitätsklinikum St. Pölten
Sankt Pölten, Austria· Recruiting
Klinikum Wels-Grieskirchen GmbH
Wels, Austria· Recruiting
Universitätsklinikum Wiener Neustadt
Wiener Neustadt, Austria· Recruiting
OLV Ziekenhuis Campus Aalst
Aalst, Belgium· Recruiting
AZ Sint-Jan Brugge-Campus Sint-Jan
Bruges, Belgium· Recruiting
Centre hospitaliser régional (CHR) de la Citadelle
Liège, Belgium· Recruiting

+74 more sites — see the official record for the full list.

Common questions

What is a defibrillator?

It's a small device implanted under your skin, usually below your collarbone, that monitors your heart rhythm. If it detects a life-threatening fast heartbeat, it can deliver an electric shock to reset it.

What does 'optimal medical therapy' mean?

This refers to the best combination of medicines currently available and recommended by doctors to treat your heart condition, aiming to improve your heart's health and reduce risks.

Why is my heart called 'weakened' or 'reduced LVEF'?

After a heart attack, the pumping ability of your heart muscle can be affected. Reduced LVEF simply means your heart isn't pumping blood as strongly as it should, making it weaker.

Will I know which treatment group I'm in?

This study will likely be 'blinded' for some aspects, meaning you might not know which treatment group you're in (with or without a defibrillator) at first, to keep the results fair. Your medical team will know, and will always act in your best interest.

What if my health changes during the study?

Your health will be closely monitored, and your study doctor will make sure you receive any necessary medical interventions if your condition changes, regardless of your study group.

How to find out more

Gerhard Hindricks, Prof

Gerhard.Hindricks@dhzc-charite.de +49 30 450 513211 Official trial record

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