We'd like your feedback
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Contact the study team using the details below to take part. If there are no contact details below please ask your doctor in the first instance.
Daniel
Griffiths
british@soton.ac.uk
Katerina
Samouri
katerina.samouri@nihr.ac.uk
Andrew
Flett
andrew.flett@uhs.nhs.uk
Daniel
Griffiths
british@soton.ac.uk
Other forms of heart disease
This information is provided directly by researchers, and we recognise that it isn't always easy to understand. We are working with researchers to improve the accessibility of this information. In some summaries, you may come across links to external websites. These websites will have more information to help you better understand the study.
Some patients with severe Non-Ischaemic Cardiomyopathy (NICM), or heart failure that is not caused by diseased heart arteries, have a higher risk of experiencing serious abnormal heart rhythms that might be life threatening. Current guidelines recommend consideration of a device called an Implantable Cardioverter-Defibrillator (ICD) that can correct these. However, as many as 90% of patients with an ICD never use it because they do not experience a serious heart rhythm. In addition, as many as 1 in every 6 with an ICD experience a problem e.g. infection, lead problems and inappropriate shocks.
A recent large trial (DANISH) of over 1000 patients with severe NICM, has called these guidelines into question. The trial concluded that receiving an ICD did not reduce the overall likelihood of dying. As a result, 50% of Cardiologists changed their practice, implanting ICDs in fewer patients with this type of heart failure, believing there to be no long-term benefit.
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 abnormal heart rhythms. We would like to test whether the presence of scar tissue on CMR can be used to decide if patients need an ICD or not.
BRITISH will randomise participants with this condition to two groups. Half will receive an ICD and half will not. Participants will undergo baseline blood tests and two questionnaires. They will be followed up at 36 months and remotely at 10 years. The aim is to compare death from any cause between these two groups.
There is no agreement on how to decide which patients will actually benefit from an ICD. Despite guidelines, individual doctors are making their own decisions. The results from BRITISH have the potential to change guidelines and improve how NICM patients are managed worldwide.
Start dates may differ between countries and research sites. The research team are responsible for keeping the information up-to-date.
The recruitment start and end dates are as follows:
Type: Management of Care;
You can take part if:
You may not be able to take part if:
EXCLUSION CRITERIA ● New York Heart Association (NYHA) HF functional class IV after 3 months of optimal medical therapy (OMT) ● Current acute decompensated heart failure ● Previous implantable device in situ (PPM, CRT or ICD. Prior ILR is NOT an exclusion criteria). ● Ischemic cardiomyopathy (ICM) defined as segmental wall motion abnormalities or wall thinning in a particular coronary territory with subendocardial or transmural LGE. Patients with an LVEF < = 35% and a small amount of ischemic LGE (i.e. an infarct out of keeping with the amount of LV dysfunction) will not be excluded (so called dual pathology patients) ● Diagnosis of amyloidosis, sarcoidosis, arrhythmogenic right ventricular cardiomyopathy or hypertrophic cardiomyopathy (diseases in which there are specific guidelines regarding defibrillator therapy) ● Known Lamin gene mutation or a known positive family history of a Lamin gene mutation ● Valve disease considered likely to require surgery within 3 years ● Complex congenital heart disease ● History of ventricular arrhythmias requiring a “secondary prevention” ICD. ● Heart transplant recipient or admitted for cardiac transplantation/ left ventricular assist device ● Clinically apparent myocardial ischemia which requires revascularisation ● Intra cardiac mass which requires surgery ● Active endocarditis or septicaemia ● Pregnancy ● Life expectancy < 3 years secondary to any other cause (i.e. malignancy) ● Active treatment with chemotherapy ● Severe renal failure (eGFR < 30) ● Patient enrolled into any other ongoing randomised trial can only enter with the consent of both chief investigators.
Below are the locations for where you can take part in the trial. Please note that not all sites may be open.
Andrew
Flett
andrew.flett@uhs.nhs.uk
Daniel
Griffiths
british@soton.ac.uk
Katerina
Samouri
katerina.samouri@nihr.ac.uk
Daniel
Griffiths
british@soton.ac.uk
The study is sponsored by UNIVERSITY HOSPITAL SOUTHAMPTON NHS FOUNDATION TRUST and funded by BRITISH HEART FOUNDATION .
Your feedback is important to us. It will help us improve the quality of the study information on this site. Please answer both questions.
Read full details
for Trial ID: CPMS 47314
You can print or share the study information with your GP/healthcare provider or contact the research team directly.
