At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronisation Therapy Defibrillator (CRTD) (device)
- How long the study runs
- Study runs about 106 months (dates as stated)
- About the drug or intervention
- Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronisation Therapy Defibrillator (CRTD) — device: An ICD is a device that is implanted under the skin under a local anesthetic.
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years and over
- Who
- All
- Number of participants
- 2,504
- Started
- 2023-04-12
- Last checked
- 2026-06
Plain English Summary
What is this study?
- • Testing a new treatment for heart failure
- • NA - 2,504 participants
- • 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
Who can take part?
- • Ages 18 Years and over
- • Diagnosed with heart failure
Where?
- • High Wycombe - Wycombe Hospital
- • Plymouth - Derriford Hospital
- • Bournemouth - Royal Bournemouth Hospital
- • Darlington - Durham & Darlington NHS Foundation Trust
- • +43 more UK sites
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
More detail
Patients with Non-Ischemic Cardiomyopathy (NICM) have a higher risk of experiencing serious abnormal heart rhythms that might be life-threatening. Current guidelines recommend fitting a device that can correct these serious heart rhythms (Implantable Cardioverter-Defibrillator (ICD)). However, research studies have shown that 90% of patients who have an ICD will never use it because they won't experience any serious heart rhythms. A recent large trial (DANISH) of over one thousand patients with severe Non-Ischemic Cardiomyopathy has called the current guidelines into question. The trial concluded that for patients who received an ICD, there was no difference in the likelihood of dying when compared to patients that didn't have an ICD fitted. As a result, many doctors are choosing not to implant an ICD in patients with this type of heart failure, as they believe there is no overall survival benefit. However, there are clues that some patients with NICM may still benefit from an ICD, even though the headline results suggest they are not necessary. It's likely that it's the patients who are at increased risk of having a serious abnormal heart rhythm that stand to benefit from ICDs. But having an ICD fitted carries with it a significant risk of problems developing e.g. bleeding, infection, lead problems, and inappropriate shocks. These risks may not outweigh the benefits and it is this question which BRITISH will address. The study will randomly assign (like the toss of a coin), half the study participants to receive an ICD and the other half to no ICD. Both groups will be followed up to decide whether having an ICD fitted reduces the chances of dying.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years and over
- Who can join: All genders
Biomarkers mentioned
Treatment history
Treatments you must NOT have had:
- ✗ agreement between both Chief Investigators
What the study is looking for
- ✓A diagnosis of NICM on contrast-enhanced cardiovascular magnetic resonance imaging
- ✓LV scar on routine CMR (patient without scar can enter the registry)
- ✓Able and willing to provide agreement to take part
Who cannot take part
- ✗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, heart Resynchronisation Therapy (CRT) or ICD)
- ✗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
See the full criteria
Where Is This Study? (47 UK sites)
Wycombe Hospital
High Wycombe HP11 2TT, United Kingdom
Derriford Hospital
Plymouth PL6 8DH, United Kingdom
Royal Bournemouth Hospital
Bournemouth BH7 7DW, United Kingdom
Durham & Darlington NHS Foundation Trust
Darlington DL3 6HX, United Kingdom
Royal Sussex County Hospital
Brighton BN2 5BE, United Kingdom
Essex Cardiothoracic Centre
Basildon SS16 5NL, United Kingdom
James Paget University Hospitals NHS FT
Gorleston-on-Sea NR31 6LA, United Kingdom
Portsmouth Hospitals University NHS Trust
Portsmouth PO6 3LY, United Kingdom
Southampton Clinical Trials Unit
Southampton SO16 6YD, United Kingdom
University Hospital Southampton NHS Foundation Trust
Southampton SO16 6YD, United Kingdom
Kent & Canterbury Hospital
Canterbury CT1 3NG, United Kingdom
Maidstone Hospital, Maidstone & Tunbridge Wells NHS Trust
Maidstone ME16 9QQ, United Kingdom
Blackpool Victoria Hospiatal
Blackpool FY3 8NR, United Kingdom
Liverpool Heart & Chest
Liverpool L14 3PE, United Kingdom
Glenfield Hospital
Leicester LE3 9QP, United Kingdom
St Bartholomew's Hospital
London EC1A 7BE, United Kingdom
Royal Free Hospital
London NW3 2QG, United Kingdom
Guy's Hospital
London SE1 9RT, United Kingdom
King's College Hospital
London SE5 9RS, United Kingdom
Royal Brompton Hospital
London SW3 6NP, United Kingdom
Hammersmith Hospital, Imperial College Healthcare NHS Trust
London Wq12 0HS, United Kingdom
St George's Hospital
Tooting SW17 0QT, United Kingdom
Fairfield General Hospital, Northern Care Alliance NHS FT
Manchester BL9 7TD, United Kingdom
Newcastle Freeman Hospital
Newcastle NE7 7DN, United Kingdom
The James Cook University Hospital
Middlesbrough TS4 3BW, United Kingdom
Wansbeck General Hospital
Ashington NE63 9JJ, United Kingdom
Scarborough Hospital
Scarborough YO12 6QL, United Kingdom
Nottingham City Hospital
Nottingham NG5 1PB, United Kingdom
The John Radcliffe Hospital
Oxford OX3 9DU, United Kingdom
Aberdeen Royal Infirmary
Aberdeen AB25 2ZN, United Kingdom
Royal Infirmary of Edinburgh
Edinburgh EH16 4SA, United Kingdom
Musgrove Park Hospital
Taunton TA1 5DA, United Kingdom
Northern General Hospital
Sheffield S5 7AU, United Kingdom
University Hospital of North Tees
Hardwick TS19 8PE, United Kingdom
Frimley Park Hospital
Camberley GU16 7UJ, United Kingdom
Surrey & Sussex Healthcare NHS Trust
Redhill RH1 5RH, United Kingdom
University Hospital of Wales
Cardiff CF14 4XW, United Kingdom
University Hospital Coventry
Coventry CV2 2DX, United Kingdom
New Cross Hospital
Wolverhampton WV10 0QP, United Kingdom
St Richards Hospital
Chichester PO19 6SE, United Kingdom
Leeds General Infirmary
Leeds LS1 3EX, United Kingdom
Pinderfields Hospital
Wakefield WF1 4DG, United Kingdom
Worcestershire Royal Hospital
Worcester WR5 1DD, United Kingdom
Wythenshaw Hospital
Manchester M23 9LT, United Kingdom
Castle Hill Hospital
Hull HU16 5JQ, United Kingdom
Royal Devon & Exeter Hospital
Exeter EX2 5DW, United Kingdom
Morriston Hospital
Swansea SA6 6NL, United Kingdom
How to Get in Touch
Abigail Jones
Sponsor contactCONTACT
Pedro Rodrigues
Sponsor contactCONTACT