All studies
RecruitingNAINTERVENTIONAL

RCT of Implantable Defibrillators in Patients With Non Ischemic Cardiomyopathy, Scar and Severe Systolic Heart Failure

The BRITISH study is examining if a small implanted device, similar to a pacemaker, called an Implantable Cardioverter-Defibrillator (ICD) improves the lives of people with a type of heart failure not caused by blocked arteries. Earlier research has questioned whether these devices truly benefit everyone with this condition, as many patients never experience the serious heart rhythm problems the device is designed to treat. This study aims to find out if fitting an ICD reduces the risk of death from any cause over 3 to 10 years. The results could help doctors decide who might benefit most from this device and could change future treatment guidelines for this condition.

At a glance

Status
Recruiting
Phase
NA
Sponsor
University Hospital Southampton NHS Foundation Trust
Enrolment target
2,504
Start
12 Apr 2023
Estimated completion
01 Apr 2036

What is this study about?

The BRITISH team is conducting a study to better understand a type of heart failure called Non-Ischemic Cardiomyopathy (NICM). This is heart failure that isn't caused by narrowed or blocked heart arteries, but by other reasons. People with NICM can sometimes have serious, fast heart rhythms that can be dangerous. To prevent this, doctors sometimes suggest a small device called an Implantable Cardioverter-Defibrillator (ICD) that can correct these rhythms.

However, there's been some debate about how much ICDs truly help everyone with NICM. Some studies have suggested that a large number of patients with an ICD might never actually need it to deliver a life-saving shock. Because putting in an ICD isn't without its own risks, such as bleeding or infection, doctors want to know for sure if the benefits outweigh these potential problems for all patients, or if certain groups of patients benefit more than others. This study will help clarify this important question.

The BRITISH study will look at two groups of patients with NICM: one group will receive an ICD, and the other will not. Researchers will then compare how long people in each group live over a period of 3 to 10 years. The findings from this study are very important because they could lead to changes in how heart failure is treated, helping to ensure that patients receive the most effective and safest care possible.

Key takeaways

  • This study investigates if an ICD helps people with a specific type of heart failure live longer.
  • It compares patients who receive an ICD with those who don't.
  • The results could change future heart failure treatment advice for doctors.
  • Participation involves a random assignment to either receive an ICD or not.
  • The study aims to understand who benefits most from ICDs.
  • Follow-up will last from 3 to 10 years, monitoring overall health.

Who may be eligible?

To join this study, you must have been diagnosed with heart failure not caused by blocked arteries (Non-Ischemic Cardiomyopathy), which has been confirmed by a special heart scan (MRI). Your heart must also show some scarring on this scan. Your heart failure symptoms should be manageable with medication (not severely limiting your daily activities), and despite taking the best available medicines for at least three months, your heart's main pumping chamber (left ventricle) still isn't working as well as it should.

You would not be able to take part if your heart failure symptoms are very severe (meaning you're breathless even at rest or with very little activity). You also can't participate if you've recently had a sudden worsening of your heart failure, or if you already have a pacemaker or a similar implanted device. The study also excludes people with heart failure caused by blocked arteries, or those with specific other heart conditions where defibrillator treatment guidelines are already clear. People who have certain other serious conditions that might limit their life expectancy to less than two years, or who are pregnant, would also not be able to 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.

  1. Have you been diagnosed with heart failure not caused by blocked arteries?
  2. Has a heart MRI scan shown scarring on your heart?
  3. Are your heart failure symptoms generally manageable with medication?
  4. Are you able to agree to take part in the study and understand what it involves?
  5. Do you already have a pacemaker or similar implanted heart device?
  6. Are you currently pregnant?
Answer every question to see your result.

What does participation involve?

If you join the BRITISH study, there's a 50/50 chance, like flipping a coin, that you'll either receive an Implantable Cardioverter-Defibrillator (ICD) or continue with your usual heart failure treatment without one. The doctors leading the study decide this randomly, and neither you nor your doctor can choose. Everyone taking part will have regular check-ups to monitor their heart health. The study will closely follow participants for at least 3 years, and potentially up to 10 years, to see how everyone is doing. All participants will continue to receive the best available medical treatment for their heart failure, regardless of whether they have an ICD or not.

Potential risks and benefits

Taking part in this study could help future patients with heart failure by giving doctors clearer information on the best treatment choices. If you receive an ICD, it might protect you from life-threatening abnormal heart rhythms. However, having an ICD fitted carries potential risks, including bleeding, infection, problems with the device or its wires, or receiving an unnecessary shock. If you are in the group that doesn't receive an ICD, there's a chance you could experience a serious heart rhythm problem that the device might have prevented. You are free to withdraw from the study at any time, for any reason, without affecting your future medical care.

Locations (47)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.
  • Wycombe Hospital
    Verified postcode
    High Wycombe, United Kingdom· Recruiting
  • Derriford Hospital
    Verified postcode
    Plymouth, United Kingdom· Recruiting
  • Royal Bournemouth Hospital
    Verified postcode
    Bournemouth, United Kingdom· Recruiting
  • Durham & Darlington NHS Foundation Trust
    Verified postcode
    Darlington, United Kingdom· Recruiting
  • Royal Sussex County Hospital
    Verified postcode
    Brighton, United Kingdom· Recruiting
  • Essex Cardiothoracic Centre
    Verified postcode
    Basildon, United Kingdom· Recruiting
  • James Paget University Hospitals NHS FT
    Verified postcode
    Gorleston-on-Sea, United Kingdom· Recruiting
  • Portsmouth Hospitals University NHS Trust
    Verified postcode
    Portsmouth, United Kingdom· Recruiting
  • Southampton Clinical Trials Unit
    Verified postcode
    Southampton, United Kingdom· Not yet recruiting
  • University Hospital Southampton NHS Foundation Trust
    Verified postcode
    Southampton, United Kingdom· Recruiting
  • Kent & Canterbury Hospital
    Verified postcode
    Canterbury, United Kingdom· Recruiting
  • Maidstone Hospital, Maidstone & Tunbridge Wells NHS Trust
    Verified postcode
    Maidstone, United Kingdom· Recruiting

Common questions

What is Non-Ischemic Cardiomyopathy?

It's a type of heart failure where the heart muscle doesn't pump blood effectively, but it's not caused by blocked arteries.

What is an Implantable Cardioverter-Defibrillator (ICD)?

It's a small device placed under the skin near your collarbone with wires going to your heart. It monitors your heart rhythm and can deliver an electrical shock to correct very fast or dangerous heartbeats.

Will I know if I'm getting an ICD if I join?

No, whether you receive an ICD or not is decided randomly, like a coin toss, to keep the study fair and unbiased. Neither you nor your doctor can choose.

How long will I be followed in the study?

You will be followed and your health monitored for at least 3 years, and potentially for up to 10 years.

Can I leave the study at any time?

Yes, you have the right to withdraw from the study at any point, and this will not affect your ongoing medical care.

How to find out more

Zina Eminton

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

Interested in taking part?

Register your interest

Share your details and the research team for "RCT of Implantable Defibrillators in Patients With Non Ische…" will contact you if you may be eligible. Always speak to your GP before agreeing to take part.

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