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Trial details imported from ClinicalTrials.gov

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


Additional trial details provided through ANZCTR are available at the end of this record.


Registration number
NCT05568069
Ethics application status
Date submitted
27/09/2022
Date registered
5/10/2022

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
Trial website
Trial related presentations / publications
Public notes

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

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

No documents have been uploaded by study researchers.


Results not provided in https://clinicaltrials.gov/study/NCT05568069

Additional trial details provided through ANZCTR
Accrual to date
Recruitment state(s)
Funding & Sponsors
Primary sponsor
University
Primary sponsor name
Flinders University
Primary sponsor address
Primary sponsor country
Australia
Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 75
Southern Adelaide Local Health Network
Address [1] 75
Southern Adelaide Local Health Network Gus Fraenkel Medical Library, Research Hub Level 5, 5E240, Flinders Medical Centre, Flinders Dr, Bedford Park SA 5042 - Kaurna Country
Country [1] 75
Australia
Date submitted for ethics approval [1] 75
Approval date [1] 75
Ethics approval number [1] 75
 
Public notes

Contacts
Principal investigator
Title 437 0
Prof
Name 437 0
Joseph Selvanayagam
Address 437 0
Cardiology Department, Flinders Medical Centre 1 Flinders Drive Bedford Park SA 5042
Country 437 0
Australia
Phone 437 0
+61 (0)8 8404 2195
Fax 437 0
Email 437 0
Contact person for public queries
Title 438 0
Dr
Name 438 0
Sivabaskari Pasupathy
Address 438 0
Cardiology Department College of Medicine & Public Health Sturt Road, Bedford Park South Australia 5042 GPO Box 2100 Adelaide SA 5001
Country 438 0
Australia
Phone 438 0
Fax 438 0
Email 438 0
tharshy.pasupathy@flinders.edu.au
Contact person for scientific queries
Title 439 0
Prof
Name 439 0
Joseph Selvanayagam
Address 439 0
Cardiology Department, Flinders Medical Centre 1 Flinders Drive Bedford Park SA 5042
Country 439 0
Australia
Phone 439 0
+61 (0)8 8404 2195
Fax 439 0
Email 439 0