The BRITISH Study

What is the BRITISH study?

Background and study aim

Non-ischaemic cardiomyopathy (NICM) is a common cause of heart failure accounting for around a third of cases in the UK. 'Non-ischaemic' refers to the fact that the weakness of the heart muscle that characterises the condition is not primarily due to the blood flow down the coronary arteries.

Some patients with NICM have a higher risk of experiencing serious abnormal heart rhythms that might be life threatening. Current guidelines recommend doctors consider fitting a device called an Implantable Cardioverter-Defibrillator (ICD) that can correct these serious heart rhythms by delivering an electric shock to the patient’s heart.

The current guidelines look at how well the heart is pumping to decide which patients should get an implant. However, we know from previous research studies as many as 90% of patients who have an ICD will never need to use it because they won’t experience any serious heart rhythms.

Research has shown that patients who have scar tissue in their heart, seen on Cardiac Magnetic Resonance Imaging (CMR), are at a higher risk of dying suddenly from an abnormal heart rhythm.

The BRITISH study will test whether the presence of scar tissue on the heart scan (CMR) can be used to decide if patients need an ICD or not.

Who can participate?

Adults over the age of 18 years with Non-Ischaemic Cardiomyopathy who have severe heart failure despite 3 months of optimum medical therapy and have the presence of scar tissue on their routine heart scan (CMR).

What does the study involve?

Participants will be randomly assigned (like the toss of a coin) to one of two study arms. Half the study participants will receive an ICD and the other half to no ICD. For participants that are allocated to no ICD, we’d still like to monitor the heart rhythm and this can be done simply by fitting a device called an Implantable Loop Recorder (ILR) which records the heart rhythm.

Both groups will be followed up to decide whether having an ICD fitted reduces the chances of dying from an abnormal heart rhythm.

What are the possible benefits and risks of participating?

There may be no personal benefit for participants in this study. We hope there may be some benefit to patients in not having an ICD fitted if they don’t need one. However, we can’t be sure of this and this is why we’re doing the study.

Even if there is no personal benefit to participants, we hope this study will increase our knowledge and improve how we manage patients with this condition in the future. We hope the study results might lead to a change in the guidelines used by doctors when they decide which heart failure patients should have an ICD fitted.

Whether patients decide to take part in the research study or not, there are certain risks associated in having an ICD fitted, and these are outlined in the Participant Information Sheet. The study will not increase or decrease any risk around this procedure.

 

 

The BRITISH study is funded by a research grant from the British Heart Foundation and is sponsored by University Hopsitals Southampton NHS Foundation Trust.