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

Status: Recruiting
Location: See all (47) locations...
Intervention Type: Device
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• A diagnosis of NICM on contrast-enhanced cardiovascular magnetic resonance imaging

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

• 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)

• Able and willing to provide informed consent

Locations
Other Locations
United Kingdom
Aberdeen Royal Infirmary
RECRUITING
Aberdeen
Wansbeck General Hospital
ACTIVE_NOT_RECRUITING
Ashington
Essex Cardiothoracic Centre
RECRUITING
Basildon
Blackpool Victoria Hospiatal
RECRUITING
Blackpool
Royal Bournemouth Hospital
RECRUITING
Bournemouth
Royal Sussex County Hospital
RECRUITING
Brighton
Frimley Park Hospital
RECRUITING
Camberley
Kent & Canterbury Hospital
RECRUITING
Canterbury
University Hospital of Wales
RECRUITING
Cardiff
St Richards Hospital
RECRUITING
Chichester
University Hospital Coventry
RECRUITING
Coventry
Durham & Darlington NHS Foundation Trust
RECRUITING
Darlington
Royal Infirmary of Edinburgh
RECRUITING
Edinburgh
Royal Devon & Exeter Hospital
RECRUITING
Exeter
James Paget University Hospitals NHS FT
RECRUITING
Gorleston-on-sea
University Hospital of North Tees
RECRUITING
Hardwick
Wycombe Hospital
RECRUITING
High Wycombe
Castle Hill Hospital
RECRUITING
Hull
Leeds General Infirmary
RECRUITING
Leeds
Glenfield Hospital
RECRUITING
Leicester
Liverpool Heart & Chest
RECRUITING
Liverpool
Guy's Hospital
RECRUITING
London
Hammersmith Hospital, Imperial College Healthcare NHS Trust
RECRUITING
London
King's College Hospital
RECRUITING
London
Royal Brompton Hospital
RECRUITING
London
Royal Free Hospital
RECRUITING
London
St Bartholomew's Hospital
RECRUITING
London
Maidstone Hospital, Maidstone & Tunbridge Wells NHS Trust
RECRUITING
Maidstone
Fairfield General Hospital, Northern Care Alliance NHS FT
RECRUITING
Manchester
Wythenshaw Hospital
RECRUITING
Manchester
The James Cook University Hospital
RECRUITING
Middlesbrough
Newcastle Freeman Hospital
RECRUITING
Newcastle
Nottingham City Hospital
RECRUITING
Nottingham
The John Radcliffe Hospital
RECRUITING
Oxford
Derriford Hospital
RECRUITING
Plymouth
Portsmouth Hospitals University NHS Trust
RECRUITING
Portsmouth
Surrey & Sussex Healthcare NHS Trust
RECRUITING
Redhill
Scarborough Hospital
RECRUITING
Scarborough
Northern General Hospital
RECRUITING
Sheffield
Southampton Clinical Trials Unit
NOT_YET_RECRUITING
Southampton
University Hospital Southampton NHS Foundation Trust
RECRUITING
Southampton
Morriston Hospital
RECRUITING
Swansea
Musgrove Park Hospital
ACTIVE_NOT_RECRUITING
Taunton
St George's Hospital
RECRUITING
Tooting
Pinderfields Hospital
RECRUITING
Wakefield
New Cross Hospital
RECRUITING
Wolverhampton
Worcestershire Royal Hospital
RECRUITING
Worcester
Contact Information
Primary
Zina Eminton
z.b.eminton@soton.ac.uk
023 8026 8125
Backup
Zoe Nicholas
zoe.nicholas@uhs.nhs.uk
023 8120 8538
Time Frame
Start Date: 2023-04-12
Estimated Completion Date: 2036-04-01
Participants
Target number of participants: 2504
Treatments
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
Sponsors
Leads: University Hospital Southampton NHS Foundation Trust
Collaborators: British Heart Foundation, University of Southampton

This content was sourced from clinicaltrials.gov