BRITISH:Using CMR scar as risk indication tool in NICM and severe LVSD
Research type
Research Study
Full title
Using cardiovascular magnetic resonance identified scar as the Benchmark Risk Indication Tool for Implantable cardioverter defibrillators in patients with Non-Ischemic Cardiomyopathy and Severe systolic Heart failure (BRITISH)
IRAS ID
280862
Contact name
Andrew S Flett
Contact email
Sponsor organisation
University Hospital Southampton NHS Foundation Trust
Clinicaltrials.gov Identifier
Duration of Study in the UK
9 years, 2 months, 26 days
Research summary
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.
REC name
London - Fulham Research Ethics Committee
REC reference
20/LO/1155
Date of REC Opinion
27 Nov 2020
REC opinion
Further Information Favourable Opinion