Trial Review

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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
Date last updated
16/05/2024

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:
Condition category
Condition code

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Placebo comparator: Placebo plus corticosteroids -

Comparator / control treatment
Control group

Outcomes

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
NA
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)

Funding & Sponsors
Primary sponsor type
Other
Name
University Hospital Southampton NHS Foundation Trust
Address
Country

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
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


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
[email protected]
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