RCT of Implantable Defibrillators in Patients With Non Ischemic Cardiomyopathy, Scar and Severe Systolic Heart Failure
Recruiting · NCT05568069 · Interventional (participants receive a specific treatment) · Lead sponsor: University Hospital Southampton NHS Foundation Trust
View the official record on ClinicalTrials.gov →Interventions studied
Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronisation Therapy Defibrillator (CRTD)
What this trial is about
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.
Who can take part
Age range
18 Years and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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 criteria
- 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)
- 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
- Any secondary prevention ICD indication
- Heart transplant recipient or admitted for cardiac transplantation/ left ventricular assist device
- Clinically apparent myocardial ischemia which requires revascularization
- Intracardiac mass which requires surgery
- Active endocarditis
- Active Septicaemia
- Pregnancy
- Life expectancy \<2 years secondary to any other cause (i.e. malignancy)
- Active treatment with chemotherapy
- Severe renal failure (GFR \<30)
- Actively participating in another study without prior agreement between both Chief Investigators
Where it is running
47 locations listed.
- Royal Devon & Exeter Hospital - Exeter, United Kingdom
- Morriston Hospital - Swansea, United Kingdom
- Wycombe Hospital - High Wycombe, Buckinghamshire, United Kingdom
- Derriford Hospital - Plymouth, Devon, United Kingdom
- Royal Bournemouth Hospital - Bournemouth, Dorset, United Kingdom
- Durham & Darlington NHS Foundation Trust - Darlington, Durham, United Kingdom
- Royal Sussex County Hospital - Brighton, East Sussex, United Kingdom
- Essex Cardiothoracic Centre - Basildon, Essex, United Kingdom
- James Paget University Hospitals NHS FT - Gorleston-on-Sea, Great Yarmouth, United Kingdom
- Portsmouth Hospitals University NHS Trust - Portsmouth, Hampshire, United Kingdom
- Southampton Clinical Trials Unit - Southampton, Hampshire, United Kingdom
- University Hospital Southampton NHS Foundation Trust - Southampton, Hampshire, United Kingdom
- Kent & Canterbury Hospital - Canterbury, Kent, United Kingdom
- Maidstone Hospital, Maidstone & Tunbridge Wells NHS Trust - Maidstone, Kent, United Kingdom
- Blackpool Victoria Hospiatal - Blackpool, Lancashire, United Kingdom
- Liverpool Heart & Chest - Liverpool, Lancashire, United Kingdom
- Glenfield Hospital - Leicester, Leicestershire, United Kingdom
- St Bartholomew's Hospital - London, London, United Kingdom
- Royal Free Hospital - London, London, United Kingdom
- Guy's Hospital - London, London, United Kingdom
- King's College Hospital - London, London, United Kingdom
- Royal Brompton Hospital - London, London, United Kingdom
- Hammersmith Hospital, Imperial College Healthcare NHS Trust - London, London, United Kingdom
- St George's Hospital - Tooting, London, United Kingdom
- Fairfield General Hospital, Northern Care Alliance NHS FT - Manchester, Manchester, United Kingdom
- Newcastle Freeman Hospital - Newcastle, Newcastle Upon Tyne, United Kingdom
- The James Cook University Hospital - Middlesbrough, North Yorkshire, United Kingdom
- Wansbeck General Hospital - Ashington, Northumbria, United Kingdom
- Scarborough Hospital - Scarborough, Nortrh Yorkshire, United Kingdom
- Nottingham City Hospital - Nottingham, Nottinghamshire, United Kingdom
- The John Radcliffe Hospital - Oxford, Oxfordshire, United Kingdom
- Aberdeen Royal Infirmary - Aberdeen, Scotland, United Kingdom
- Royal Infirmary of Edinburgh - Edinburgh, Scotland, United Kingdom
- Musgrove Park Hospital - Taunton, Somerset, United Kingdom
- Northern General Hospital - Sheffield, South Yorkshire, United Kingdom
- University Hospital of North Tees - Hardwick, Stockton-on-Tees, United Kingdom
- Frimley Park Hospital - Camberley, Surrey, United Kingdom
- Surrey & Sussex Healthcare NHS Trust - Redhill, Surrey, United Kingdom
- University Hospital of Wales - Cardiff, Wales, United Kingdom
- University Hospital Coventry - Coventry, Warwickshire, United Kingdom
- New Cross Hospital - Wolverhampton, West Midlands, United Kingdom
- St Richards Hospital - Chichester, West Sussex, United Kingdom
- Leeds General Infirmary - Leeds, West Yorkshire, United Kingdom
- Pinderfields Hospital - Wakefield, West Yorkshire, United Kingdom
- Worcestershire Royal Hospital - Worcester, Worcestershire, United Kingdom
- Wythenshaw Hospital - Manchester, Wythenshaw, United Kingdom
- Castle Hill Hospital - Hull, Yorkshire, United Kingdom