Tests a heart defibrillator device in people with weak heart muscle

Trial details

Who runs it

University Hospital Southampton NHS Foundation Trust

Trial code

NCT05568069

Record updated

16 June 2026

Original description

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.Read full original descriptionShow less

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 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.

Inclusion: 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.

Exclusion: Previous implantable device in situ (PPM, Cardiac Resynchronisation Therapy (CRT) or ICD); Intracardiac mass which requires surgery; Active treatment with chemotherapy; Actively participating in another study without prior agreement between both Chief Investigators; New York Heart Association (NYHA) HF functional class IV after 3 months of optimal medical therapy (OMT); Acute decompensated heart failure; Known 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 positive family history of a Lamin gene mutation; Valve disease is considered likely to require surgery during the 3 years follow-up period; Complex congenital heart disease; Heart transplant recipient or admitted for cardiac transplantation/ left ventricular assist device; Clinically apparent myocardial ischemia which requires revascularization; 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); Severe renal failure (GFR <30); Life expectancy <2 years secondary to any other cause (i.e. malignancy); Any secondary prevention ICD indication; Active endocarditis; Active Septicaemia; Pregnancy.

ClinicalTrials.gov NCT05568069