BRITISH is a UK multicentre trial of patients who have been diagnosed with heart failure due to Non-Ischemic Cardiomyopathy (NICM, or heart failure that is not caused by blocked heart arteries. Participants will be randomised into two groups. Half the participants will receive an Implantable Cardioverter-Defibrillator (ICD) and the other half will not. The aim of the study will be to compare all-cause mortality (death from any cause) between these two groups at 36 months, and longer-term to 10 years. The study has the potential to change international heart failure treatment guidelines and to improve how patients with this condition are managed.
A diagnosis of NICM on contrast-enhanced cardiovascular magnetic resonance imaging
LV scar on routine CMR (patient without scar can enter the registry)
New York Heart Association (NYHA) Heart Failure (HF) functional class I-III and severely impaired left ventricular function (LVEF ≤ 35% on any imaging modality) after a minimum of 3 months of treatment with optimal medical therapy (OMT) as recommended by National Institute for Health and Care Excellence (NICE)
Able and willing to provide informed consent
New York Heart Association (NYHA) HF functional class IV after 3 months of optimal medical therapy (OMT)
Acute decompensated heart failure
Previous implantable device in situ (PPM, Cardiac Resynchronisation Therapy (CRT) or ICD)
Ischemic cardiomyopathy (ICM) is defined as segmental wall motion abnormalities or wall thinning in a particular coronary territory with subendocardial or transmural late gadolinium enhancement (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)
Parallel
Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronisation Therapy Defibrillator (CRTD)
DeviceAn ICD is a device that is implanted under the skin under a local anesthetic. It has a battery/generator component and leads which are fixed into the heart chambers. It has the ability to detect dangerous heart rhythms if they occur, and deliver a shock to treat this to help prevent sudden cardiac death. A CRTD is a pacemaker with a defibrillator function.
Percentage of patients alive
All-cause mortality
Change in health-related quality of life measured using KCCQ-12
Short questionnaire including questions related to heart failure symptoms and how they affect daily activities
Change in health-related quality of life measured using EQ-5D-5L
Questionnaire consisting of 5 questions to evaluate a patients quality of life
Cardiovascular Death
Percentage of patients that have cardiovascular death
Sudden cardiac death
Percentage of patients that have sudden cardiac death
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University Hospital Southampton NHS Foundation Trust
Lead sponsor
British Heart Foundation
Collaborator
University of Southampton
Collaborator
