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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/ct2/show/NCT05568069




Registration number
NCT05568069
Ethics application status
Date submitted
1/05/2024
Date registered
30/09/2022
Date last updated
15/05/2024

Titles & IDs
Public title
RCT of Implantable Defibrillators in Patients With Non Ischemic Cardiomyopathy, Scar and Severe Systolic Heart Failure
Scientific title
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
Secondary ID [1] 0 0
RHMCAR0581
Universal Trial Number (UTN)
Trial acronym
BRITISH
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Heart Failure 0 0
Condition category
Condition code
Cardiovascular 0 0 0 0
Coronary heart disease
Cardiovascular 0 0 0 0
Other cardiovascular diseases

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Devices - Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronisation Therapy Defibrillator (CRTD)

Experimental: Intervention - ICD or CRTD fitted

No Intervention: Control - No ICD fitted (with Implantable Loop Recorder) or Cardiac Resynchronisation Therapy
Pacemaker (CRTP)

No Intervention: Registry - Usual medical care


Treatment: Devices: Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronisation Therapy Defibrillator (CRTD)
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.
Intervention code [1] 0 0
Treatment: Devices
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Percentage of patients alive
Timepoint [1] 0 0
3 years
Secondary outcome [1] 0 0
Change in health-related quality of life measured using KCCQ-12
Timepoint [1] 0 0
3 years
Secondary outcome [2] 0 0
Change in health-related quality of life measured using EQ-5D-5L
Timepoint [2] 0 0
3 years
Secondary outcome [3] 0 0
Cardiovascular Death
Timepoint [3] 0 0
3 years
Secondary outcome [4] 0 0
Sudden cardiac death
Timepoint [4] 0 0
3 years
Secondary outcome [5] 0 0
Aborted sudden cardiac death
Timepoint [5] 0 0
3 years
Secondary outcome [6] 0 0
Appropriate ICD Therapy
Timepoint [6] 0 0
3 years
Secondary outcome [7] 0 0
Inappropriate ICD Therapy
Timepoint [7] 0 0
3 years
Secondary outcome [8] 0 0
Significant ventricular arrhythmias
Timepoint [8] 0 0
3 years
Secondary outcome [9] 0 0
NYHA Status
Timepoint [9] 0 0
3 years
Secondary outcome [10] 0 0
Heart failure hospitalisations
Timepoint [10] 0 0
3 years
Secondary outcome [11] 0 0
Cardiac hospitalisations
Timepoint [11] 0 0
3 years
Secondary outcome [12] 0 0
Procedures related to implanted device
Timepoint [12] 0 0
3 years
Secondary outcome [13] 0 0
Percentage of patients alive
Timepoint [13] 0 0
At 5 and 10 years

Eligibility
Key inclusion criteria
1. A diagnosis of NICM on contrast-enhanced cardiovascular magnetic resonance imaging

2. LV scar on routine CMR (patient without scar can enter the registry)

3. 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)

4. Able and willing to provide informed consent
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
1. New York Heart Association (NYHA) HF functional class IV after 3 months of optimal
medical therapy (OMT)

2. Acute decompensated heart failure

3. Previous implantable device in situ (PPM, Cardiac Resynchronisation Therapy (CRT) or
ICD)

4. 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)

5. Known diagnosis of amyloidosis, sarcoidosis, arrhythmogenic right ventricular
cardiomyopathy, or hypertrophic cardiomyopathy (diseases in which there are specific
guidelines regarding defibrillator therapy)

6. Known Lamin gene mutation or a positive family history of a Lamin gene mutation

7. Valve disease is considered likely to require surgery during the 3 years follow-up
period

8. Complex congenital heart disease

9. Any secondary prevention ICD indication

10. Heart transplant recipient or admitted for cardiac transplantation/ left ventricular
assist device

11. Clinically apparent myocardial ischemia which requires revascularization

12. Intracardiac mass which requires surgery

13. Active endocarditis

14. Active Septicaemia

15. Pregnancy

16. Life expectancy <2 years secondary to any other cause (i.e. malignancy)

17. Active treatment with chemotherapy

18. Severe renal failure (GFR <30)

19. Actively participating in another study without prior agreement between both Chief
Investigators

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
12/04/2023
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/04/2036
Actual
Sample size
Target
2504
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment outside Australia
Country [1] 0 0
United Kingdom
State/province [1] 0 0
Buckinghamshire
Country [2] 0 0
United Kingdom
State/province [2] 0 0
Devon
Country [3] 0 0
United Kingdom
State/province [3] 0 0
Dorset
Country [4] 0 0
United Kingdom
State/province [4] 0 0
Durham
Country [5] 0 0
United Kingdom
State/province [5] 0 0
Essex
Country [6] 0 0
United Kingdom
State/province [6] 0 0
Great Yarmouth
Country [7] 0 0
United Kingdom
State/province [7] 0 0
Hampshire
Country [8] 0 0
United Kingdom
State/province [8] 0 0
Kent
Country [9] 0 0
United Kingdom
State/province [9] 0 0
Lancashire
Country [10] 0 0
United Kingdom
State/province [10] 0 0
Leicestershire
Country [11] 0 0
United Kingdom
State/province [11] 0 0
London
Country [12] 0 0
United Kingdom
State/province [12] 0 0
Newcastle Upon Tyne
Country [13] 0 0
United Kingdom
State/province [13] 0 0
North Yorkshire
Country [14] 0 0
United Kingdom
State/province [14] 0 0
Northumbria
Country [15] 0 0
United Kingdom
State/province [15] 0 0
Nortrh Yorkshire
Country [16] 0 0
United Kingdom
State/province [16] 0 0
Nottinghamshire
Country [17] 0 0
United Kingdom
State/province [17] 0 0
Oxfordshire
Country [18] 0 0
United Kingdom
State/province [18] 0 0
Scotland
Country [19] 0 0
United Kingdom
State/province [19] 0 0
Somerset
Country [20] 0 0
United Kingdom
State/province [20] 0 0
South Yorkshire
Country [21] 0 0
United Kingdom
State/province [21] 0 0
Stockton-on-Tees
Country [22] 0 0
United Kingdom
State/province [22] 0 0
Surrey
Country [23] 0 0
United Kingdom
State/province [23] 0 0
West Midlands
Country [24] 0 0
United Kingdom
State/province [24] 0 0
West Yorkshire
Country [25] 0 0
United Kingdom
State/province [25] 0 0
Worcestershire
Country [26] 0 0
United Kingdom
State/province [26] 0 0
Exeter
Country [27] 0 0
United Kingdom
State/province [27] 0 0
Swansea

Funding & Sponsors
Primary sponsor type
Other
Name
University Hospital Southampton NHS Foundation Trust
Address
Country
Other collaborator category [1] 0 0
Other
Name [1] 0 0
British Heart Foundation
Address [1] 0 0
Country [1] 0 0
Other collaborator category [2] 0 0
Other
Name [2] 0 0
University of Southampton
Address [2] 0 0
Country [2] 0 0

Ethics approval
Ethics application status

Summary
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 website
https://clinicaltrials.gov/ct2/show/NCT05568069
Trial related presentations / publications
Public notes
This record is viewable in the ANZCTR as it had previously listed Australia and/or New Zealand as a recruitment site, however these sites have since been removed

Contacts
Principal investigator
Name 0 0
Andrew Flett
Address 0 0
University Hospital Southampton NHS Foundation Trust
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Zina Eminton
Address 0 0
Country 0 0
Phone 0 0
023 8026 8125
Fax 0 0
Email 0 0
z.b.eminton@soton.ac.uk
Contact person for scientific queries



Summary Results

For IPD and results data, please see https://clinicaltrials.gov/ct2/show/NCT05568069