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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
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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
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Secondary ID [1]
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RHMCAR0581
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Universal Trial Number (UTN)
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Trial acronym
BRITISH
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Heart Failure
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Condition category
Condition code
Cardiovascular
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Coronary heart disease
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Cardiovascular
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Other cardiovascular diseases
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Intervention/exposure
Study type
Interventional
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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.
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Intervention code [1]
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Treatment: Devices
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Percentage of patients alive
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Assessment method [1]
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All-cause mortality
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Timepoint [1]
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3 years
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Secondary outcome [1]
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Change in health-related quality of life measured using KCCQ-12
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Assessment method [1]
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Short questionnaire including questions related to heart failure symptoms and how they
affect daily activities
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Timepoint [1]
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3 years
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Secondary outcome [2]
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Change in health-related quality of life measured using EQ-5D-5L
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Assessment method [2]
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Questionnaire consisting of 5 questions to evaluate a patients quality of life
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Timepoint [2]
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3 years
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Secondary outcome [3]
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Cardiovascular Death
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Assessment method [3]
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Percentage of patients that have cardiovascular death
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Timepoint [3]
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3 years
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Secondary outcome [4]
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Sudden cardiac death
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Assessment method [4]
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Percentage of patients that have sudden cardiac death
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Timepoint [4]
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3 years
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Secondary outcome [5]
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Aborted sudden cardiac death
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Assessment method [5]
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Percentage of patients that have aborted sudden cardiac death
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Timepoint [5]
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3 years
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Secondary outcome [6]
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Appropriate ICD Therapy
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Assessment method [6]
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Percentage of patients that have appropriate ICD therapy
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Timepoint [6]
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3 years
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Secondary outcome [7]
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Inappropriate ICD Therapy
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Assessment method [7]
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Percentage of patients that have inappropriate ICD therapy
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Timepoint [7]
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3 years
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Secondary outcome [8]
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Significant ventricular arrhythmias
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Assessment method [8]
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Percentage of patients that have significant ventricular arrhythmias
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Timepoint [8]
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3 years
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Secondary outcome [9]
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NYHA Status
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Assessment method [9]
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Percentage of patients in each category
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Timepoint [9]
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3 years
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Secondary outcome [10]
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Heart failure hospitalisations
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Assessment method [10]
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Number of events
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Timepoint [10]
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3 years
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Secondary outcome [11]
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Cardiac hospitalisations
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Assessment method [11]
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Number of events
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Timepoint [11]
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3 years
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Secondary outcome [12]
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Procedures related to implanted device
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Assessment method [12]
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Number of events
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Timepoint [12]
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3 years
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Secondary outcome [13]
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Percentage of patients alive
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Assessment method [13]
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Mortality
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Timepoint [13]
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At 5 and 10 years
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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
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Minimum age
18
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Open (masking not used)
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Who is / are masked / blinded?
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Intervention assignment
Parallel
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Other design features
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Phase
Not Applicable
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Recruiting
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
12/04/2023
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
1/04/2036
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Actual
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Sample size
Target
2504
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Accrual to date
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Final
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Recruitment in Australia
Recruitment state(s)
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Recruitment outside Australia
Country [1]
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United Kingdom
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State/province [1]
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Buckinghamshire
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Country [2]
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United Kingdom
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State/province [2]
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Devon
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Country [3]
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United Kingdom
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State/province [3]
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Dorset
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Country [4]
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United Kingdom
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State/province [4]
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Durham
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Country [5]
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United Kingdom
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State/province [5]
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Essex
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Country [6]
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United Kingdom
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State/province [6]
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Great Yarmouth
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Country [7]
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United Kingdom
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State/province [7]
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Hampshire
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Country [8]
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United Kingdom
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State/province [8]
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Kent
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Country [9]
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United Kingdom
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State/province [9]
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Lancashire
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Country [10]
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United Kingdom
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State/province [10]
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Leicestershire
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Country [11]
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United Kingdom
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State/province [11]
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London
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Country [12]
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United Kingdom
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State/province [12]
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Newcastle Upon Tyne
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Country [13]
0
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United Kingdom
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State/province [13]
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North Yorkshire
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Country [14]
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United Kingdom
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State/province [14]
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Northumbria
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Country [15]
0
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United Kingdom
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State/province [15]
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Nortrh Yorkshire
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Country [16]
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United Kingdom
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State/province [16]
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Nottinghamshire
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Country [17]
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United Kingdom
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State/province [17]
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Oxfordshire
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Country [18]
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United Kingdom
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State/province [18]
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Scotland
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Country [19]
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United Kingdom
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State/province [19]
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Somerset
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Country [20]
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United Kingdom
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State/province [20]
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South Yorkshire
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Country [21]
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United Kingdom
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State/province [21]
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Stockton-on-Tees
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Country [22]
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United Kingdom
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State/province [22]
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Surrey
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Country [23]
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United Kingdom
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State/province [23]
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West Midlands
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Country [24]
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United Kingdom
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State/province [24]
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West Yorkshire
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Country [25]
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United Kingdom
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State/province [25]
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Worcestershire
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Country [26]
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United Kingdom
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State/province [26]
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Exeter
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Country [27]
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United Kingdom
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State/province [27]
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Swansea
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Funding & Sponsors
Primary sponsor type
Other
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Name
University Hospital Southampton NHS Foundation Trust
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Address
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Country
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Other collaborator category [1]
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Other
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Name [1]
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British Heart Foundation
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Address [1]
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Country [1]
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Other collaborator category [2]
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Other
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Name [2]
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University of Southampton
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Address [2]
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Country [2]
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Ethics approval
Ethics application status
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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.
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Trial website
https://clinicaltrials.gov/ct2/show/NCT05568069
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Trial related presentations / publications
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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
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Contacts
Principal investigator
Name
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Andrew Flett
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Address
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University Hospital Southampton NHS Foundation Trust
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Country
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Phone
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Fax
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Email
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Contact person for public queries
Name
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Zina Eminton
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Address
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Country
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Phone
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023 8026 8125
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Fax
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Email
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[email protected]
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT05568069
Download to PDF