RCT of Implantable Defibrillators in Patients With Non Ischemic Cardiomyopathy, Scar and Severe Systolic Heart Failure
BRITISH
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
1 other identifier
interventional
2,504
1 country
47
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable heart-failure
Started Apr 2023
Longer than P75 for not_applicable heart-failure
47 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 27, 2022
CompletedFirst Posted
Study publicly available on registry
October 5, 2022
CompletedStudy Start
First participant enrolled
April 12, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
October 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
April 1, 2036
March 5, 2026
March 1, 2026
3.5 years
September 27, 2022
March 3, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of patients alive
All-cause mortality
3 years
Secondary Outcomes (13)
Change in health-related quality of life measured using KCCQ-12
3 years
Change in health-related quality of life measured using EQ-5D-5L
3 years
Cardiovascular Death
3 years
Sudden cardiac death
3 years
Aborted sudden cardiac death
3 years
- +8 more secondary outcomes
Study Arms (3)
Intervention
EXPERIMENTALICD or CRTD fitted
Control
NO INTERVENTIONNo ICD fitted (with Implantable Loop Recorder) or Cardiac Resynchronisation Therapy Pacemaker (CRTP)
Registry
NO INTERVENTIONUsual medical care
Interventions
An 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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
- +4 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- University Hospital Southampton NHS Foundation Trustlead
- British Heart Foundationcollaborator
- University of Southamptoncollaborator
Study Sites (47)
Wycombe Hospital
High Wycombe, Buckinghamshire, HP11 2TT, United Kingdom
Derriford Hospital
Plymouth, Devon, PL6 8DH, United Kingdom
Royal Bournemouth Hospital
Bournemouth, Dorset, BH7 7DW, United Kingdom
Durham & Darlington NHS Foundation Trust
Darlington, Durham, DL3 6HX, United Kingdom
Royal Sussex County Hospital
Brighton, East Sussex, BN2 5BE, United Kingdom
Essex Cardiothoracic Centre
Basildon, Essex, SS16 5NL, United Kingdom
James Paget University Hospitals NHS FT
Gorleston-on-Sea, Great Yarmouth, NR31 6LA, United Kingdom
Portsmouth Hospitals University NHS Trust
Portsmouth, Hampshire, PO6 3LY, United Kingdom
Southampton Clinical Trials Unit
Southampton, Hampshire, SO16 6YD, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, SO16 6YD, United Kingdom
Kent & Canterbury Hospital
Canterbury, Kent, CT1 3NG, United Kingdom
Maidstone Hospital, Maidstone & Tunbridge Wells NHS Trust
Maidstone, Kent, ME16 9QQ, United Kingdom
Blackpool Victoria Hospiatal
Blackpool, Lancashire, FY3 8NR, United Kingdom
Liverpool Heart & Chest
Liverpool, Lancashire, L14 3PE, United Kingdom
Glenfield Hospital
Leicester, Leicestershire, LE3 9QP, United Kingdom
St Bartholomew's Hospital
London, London, EC1A 7BE, United Kingdom
Royal Free Hospital
London, London, NW3 2QG, United Kingdom
Guy's Hospital
London, London, SE1 9RT, United Kingdom
King's College Hospital
London, London, SE5 9RS, United Kingdom
Royal Brompton Hospital
London, London, SW3 6NP, United Kingdom
Hammersmith Hospital, Imperial College Healthcare NHS Trust
London, London, Wq12 0HS, United Kingdom
St George's Hospital
Tooting, London, SW17 0QT, United Kingdom
Fairfield General Hospital, Northern Care Alliance NHS FT
Manchester, Manchester, BL9 7TD, United Kingdom
Newcastle Freeman Hospital
Newcastle, Newcastle Upon Tyne, NE7 7DN, United Kingdom
The James Cook University Hospital
Middlesbrough, North Yorkshire, TS4 3BW, United Kingdom
Wansbeck General Hospital
Ashington, Northumbria, NE63 9JJ, United Kingdom
Scarborough Hospital
Scarborough, Nortrh Yorkshire, YO12 6QL, United Kingdom
Nottingham City Hospital
Nottingham, Nottinghamshire, NG5 1PB, United Kingdom
The John Radcliffe Hospital
Oxford, Oxfordshire, OX3 9DU, United Kingdom
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN, United Kingdom
Royal Infirmary of Edinburgh
Edinburgh, Scotland, EH16 4SA, United Kingdom
Musgrove Park Hospital
Taunton, Somerset, TA1 5DA, United Kingdom
Northern General Hospital
Sheffield, South Yorkshire, S5 7AU, United Kingdom
University Hospital of North Tees
Hardwick, Stockton-on-Tees, TS19 8PE, United Kingdom
Frimley Park Hospital
Camberley, Surrey, GU16 7UJ, United Kingdom
Surrey & Sussex Healthcare NHS Trust
Redhill, Surrey, RH1 5RH, United Kingdom
University Hospital of Wales
Cardiff, Wales, CF14 4XW, United Kingdom
University Hospital Coventry
Coventry, Warwickshire, CV2 2DX, United Kingdom
New Cross Hospital
Wolverhampton, West Midlands, WV10 0QP, United Kingdom
St Richards Hospital
Chichester, West Sussex, PO19 6SE, United Kingdom
Leeds General Infirmary
Leeds, West Yorkshire, LS1 3EX, United Kingdom
Pinderfields Hospital
Wakefield, West Yorkshire, WF1 4DG, United Kingdom
Worcestershire Royal Hospital
Worcester, Worcestershire, WR5 1DD, United Kingdom
Wythenshaw Hospital
Manchester, Wythenshaw, M23 9LT, United Kingdom
Castle Hill Hospital
Hull, Yorkshire, HU16 5JQ, United Kingdom
Royal Devon & Exeter Hospital
Exeter, EX2 5DW, United Kingdom
Morriston Hospital
Swansea, SA6 6NL, United Kingdom
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Andrew Flett
University Hospital Southampton NHS Foundation Trust
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
September 27, 2022
First Posted
October 5, 2022
Study Start
April 12, 2023
Primary Completion (Estimated)
October 1, 2026
Study Completion (Estimated)
April 1, 2036
Last Updated
March 5, 2026
Record last verified: 2026-03
Data Sharing
- IPD Sharing
- Will not share