Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
NCT05568069

RCT of Implantable Defibrillators in Patients With Non Ischemic Cardiomyopathy, Scar and Severe Systolic Heart Failure

Led by University Hospital Southampton NHS Foundation Trust · Updated on 2026-03-05

2504

Participants Needed

47

Research Sites

676 weeks

Total Duration

On this page

Sponsors

U

University Hospital Southampton NHS Foundation Trust

Lead Sponsor

B

British Heart Foundation

Collaborating Sponsor

AI-Summary

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.

CONDITIONS

Official Title

RCT of Implantable Defibrillators in Patients With Non Ischemic Cardiomyopathy, Scar and Severe Systolic Heart Failure

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Diagnosis of Non-Ischemic Cardiomyopathy confirmed by contrast-enhanced cardiovascular magnetic resonance imaging
  • Presence of left ventricular scar on routine cardiovascular magnetic resonance (patients without scar can enter registry)
  • New York Heart Association (NYHA) Heart Failure class I to III with severely reduced left ventricular function (LVEF ≤ 35%) after at least 3 months of optimal medical therapy
  • Able and willing to provide informed consent
Not Eligible

You will not qualify if you...

  • New York Heart Association (NYHA) Heart Failure class IV after 3 months of optimal medical therapy
  • Acute decompensated heart failure
  • Previous implantable cardiac device such as pacemaker, cardiac resynchronisation therapy device, or ICD
  • Ischemic cardiomyopathy with significant wall motion abnormalities and scarring in specific coronary territories
  • Known amyloidosis, sarcoidosis, arrhythmogenic right ventricular cardiomyopathy, or hypertrophic cardiomyopathy
  • Known Lamin gene mutation or family history of Lamin gene mutation
  • Valve disease likely to require surgery within 3 years
  • Complex congenital heart disease
  • Secondary prevention ICD indication
  • Heart transplant recipient or listed for transplantation or ventricular assist device
  • Clinically apparent myocardial ischemia requiring revascularization
  • Intracardiac mass requiring surgery
  • Active endocarditis or septicaemia
  • Pregnancy
  • Life expectancy less than 2 years due to other causes
  • Active chemotherapy treatment
  • Severe renal failure (GFR <30)
  • Participation in another study without agreement from chief investigators

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 47 locations

1

Wycombe Hospital

High Wycombe, Buckinghamshire, United Kingdom, HP11 2TT

Actively Recruiting

2

Derriford Hospital

Plymouth, Devon, United Kingdom, PL6 8DH

Actively Recruiting

3

Royal Bournemouth Hospital

Bournemouth, Dorset, United Kingdom, BH7 7DW

Actively Recruiting

4

Durham & Darlington NHS Foundation Trust

Darlington, Durham, United Kingdom, DL3 6HX

Actively Recruiting

5

Royal Sussex County Hospital

Brighton, East Sussex, United Kingdom, BN2 5BE

Actively Recruiting

6

Essex Cardiothoracic Centre

Basildon, Essex, United Kingdom, SS16 5NL

Actively Recruiting

7

James Paget University Hospitals NHS FT

Gorleston-on-Sea, Great Yarmouth, United Kingdom, NR31 6LA

Actively Recruiting

8

Portsmouth Hospitals University NHS Trust

Portsmouth, Hampshire, United Kingdom, PO6 3LY

Actively Recruiting

9

Southampton Clinical Trials Unit

Southampton, Hampshire, United Kingdom, SO16 6YD

Not Yet Recruiting

10

University Hospital Southampton NHS Foundation Trust

Southampton, Hampshire, United Kingdom, SO16 6YD

Actively Recruiting

11

Kent & Canterbury Hospital

Canterbury, Kent, United Kingdom, CT1 3NG

Actively Recruiting

12

Maidstone Hospital, Maidstone & Tunbridge Wells NHS Trust

Maidstone, Kent, United Kingdom, ME16 9QQ

Actively Recruiting

13

Blackpool Victoria Hospiatal

Blackpool, Lancashire, United Kingdom, FY3 8NR

Actively Recruiting

14

Liverpool Heart & Chest

Liverpool, Lancashire, United Kingdom, L14 3PE

Actively Recruiting

15

Glenfield Hospital

Leicester, Leicestershire, United Kingdom, LE3 9QP

Actively Recruiting

16

St Bartholomew's Hospital

London, London, United Kingdom, EC1A 7BE

Actively Recruiting

17

Royal Free Hospital

London, London, United Kingdom, NW3 2QG

Actively Recruiting

18

Guy's Hospital

London, London, United Kingdom, SE1 9RT

Actively Recruiting

19

King's College Hospital

London, London, United Kingdom, SE5 9RS

Actively Recruiting

20

Royal Brompton Hospital

London, London, United Kingdom, SW3 6NP

Actively Recruiting

21

Hammersmith Hospital, Imperial College Healthcare NHS Trust

London, London, United Kingdom, Wq12 0HS

Actively Recruiting

22

St George's Hospital

Tooting, London, United Kingdom, SW17 0QT

Actively Recruiting

23

Fairfield General Hospital, Northern Care Alliance NHS FT

Manchester, Manchester, United Kingdom, BL9 7TD

Actively Recruiting

24

Newcastle Freeman Hospital

Newcastle, Newcastle Upon Tyne, United Kingdom, NE7 7DN

Actively Recruiting

25

The James Cook University Hospital

Middlesbrough, North Yorkshire, United Kingdom, TS4 3BW

Actively Recruiting

26

Wansbeck General Hospital

Ashington, Northumbria, United Kingdom, NE63 9JJ

Active, Not Recruiting

27

Scarborough Hospital

Scarborough, Nortrh Yorkshire, United Kingdom, YO12 6QL

Actively Recruiting

28

Nottingham City Hospital

Nottingham, Nottinghamshire, United Kingdom, NG5 1PB

Actively Recruiting

29

The John Radcliffe Hospital

Oxford, Oxfordshire, United Kingdom, OX3 9DU

Actively Recruiting

30

Aberdeen Royal Infirmary

Aberdeen, Scotland, United Kingdom, AB25 2ZN

Actively Recruiting

31

Royal Infirmary of Edinburgh

Edinburgh, Scotland, United Kingdom, EH16 4SA

Actively Recruiting

32

Musgrove Park Hospital

Taunton, Somerset, United Kingdom, TA1 5DA

Active, Not Recruiting

33

Northern General Hospital

Sheffield, South Yorkshire, United Kingdom, S5 7AU

Actively Recruiting

34

University Hospital of North Tees

Hardwick, Stockton-on-Tees, United Kingdom, TS19 8PE

Actively Recruiting

35

Frimley Park Hospital

Camberley, Surrey, United Kingdom, GU16 7UJ

Actively Recruiting

36

Surrey & Sussex Healthcare NHS Trust

Redhill, Surrey, United Kingdom, RH1 5RH

Actively Recruiting

37

University Hospital of Wales

Cardiff, Wales, United Kingdom, CF14 4XW

Actively Recruiting

38

University Hospital Coventry

Coventry, Warwickshire, United Kingdom, CV2 2DX

Actively Recruiting

39

New Cross Hospital

Wolverhampton, West Midlands, United Kingdom, WV10 0QP

Actively Recruiting

40

St Richards Hospital

Chichester, West Sussex, United Kingdom, PO19 6SE

Actively Recruiting

41

Leeds General Infirmary

Leeds, West Yorkshire, United Kingdom, LS1 3EX

Actively Recruiting

42

Pinderfields Hospital

Wakefield, West Yorkshire, United Kingdom, WF1 4DG

Actively Recruiting

43

Worcestershire Royal Hospital

Worcester, Worcestershire, United Kingdom, WR5 1DD

Actively Recruiting

44

Wythenshaw Hospital

Manchester, Wythenshaw, United Kingdom, M23 9LT

Actively Recruiting

45

Castle Hill Hospital

Hull, Yorkshire, United Kingdom, HU16 5JQ

Actively Recruiting

46

Royal Devon & Exeter Hospital

Exeter, United Kingdom, EX2 5DW

Actively Recruiting

47

Morriston Hospital

Swansea, United Kingdom, SA6 6NL

Actively Recruiting

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Research Team

Z

Zina Eminton

CONTACT

Z

Zoe Nicholas

CONTACT

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

RANDOMIZED

Model

PARALLEL

Primary Purpose

TREATMENT

Number of Arms

3

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