RecruitingNot ApplicableNCT05568069

RCT of Implantable Defibrillators in Patients With Non Ischemic Cardiomyopathy, Scar and Severe Systolic Heart Failure

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


Sponsor

University Hospital Southampton NHS Foundation Trust

Enrollment

2,504 participants

Start Date

Apr 12, 2023

Study Type

INTERVENTIONAL

Conditions

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

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This trial studies whether implanting a defibrillator (a device that corrects dangerous heart rhythms) helps people with a specific type of heart failure caused by scarring in the heart muscle. You may be eligible if... - You have been diagnosed with non-ischemic cardiomyopathy (heart failure not caused by blocked arteries) confirmed by cardiac MRI - You have scar tissue visible on your cardiac MRI - Your heart pumping function (LVEF) is 35% or less after at least 3 months of optimal medication treatment - You are in NYHA heart failure class I, II, or III - You are able and willing to give informed consent You may NOT be eligible if... - You are in the most severe stage of heart failure (NYHA class IV) despite best treatment - You are in acutely decompensated heart failure - You already have a pacemaker, defibrillator, or cardiac resynchronization device - Your heart failure is caused by blocked arteries (ischemic cardiomyopathy) - You have been diagnosed with amyloidosis, sarcoidosis, ARVC, or hypertrophic cardiomyopathy - You have a Lamin gene mutation or a family history of one - You have significant valve disease Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEImplantable 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.


Locations(47)

Wycombe Hospital

High Wycombe, Buckinghamshire, United Kingdom

Derriford Hospital

Plymouth, Devon, United Kingdom

Royal Bournemouth Hospital

Bournemouth, Dorset, United Kingdom

Durham & Darlington NHS Foundation Trust

Darlington, Durham, United Kingdom

Royal Sussex County Hospital

Brighton, East Sussex, United Kingdom

Essex Cardiothoracic Centre

Basildon, Essex, United Kingdom

James Paget University Hospitals NHS FT

Gorleston-on-Sea, Great Yarmouth, United Kingdom

Portsmouth Hospitals University NHS Trust

Portsmouth, Hampshire, United Kingdom

Southampton Clinical Trials Unit

Southampton, Hampshire, United Kingdom

University Hospital Southampton NHS Foundation Trust

Southampton, Hampshire, United Kingdom

Kent & Canterbury Hospital

Canterbury, Kent, United Kingdom

Maidstone Hospital, Maidstone & Tunbridge Wells NHS Trust

Maidstone, Kent, United Kingdom

Blackpool Victoria Hospiatal

Blackpool, Lancashire, United Kingdom

Liverpool Heart & Chest

Liverpool, Lancashire, United Kingdom

Glenfield Hospital

Leicester, Leicestershire, United Kingdom

St Bartholomew's Hospital

London, London, United Kingdom

Royal Free Hospital

London, London, United Kingdom

Guy's Hospital

London, London, United Kingdom

King's College Hospital

London, London, United Kingdom

Royal Brompton Hospital

London, London, United Kingdom

Hammersmith Hospital, Imperial College Healthcare NHS Trust

London, London, United Kingdom

St George's Hospital

Tooting, London, United Kingdom

Fairfield General Hospital, Northern Care Alliance NHS FT

Manchester, Manchester, United Kingdom

Newcastle Freeman Hospital

Newcastle, Newcastle Upon Tyne, United Kingdom

The James Cook University Hospital

Middlesbrough, North Yorkshire, United Kingdom

Wansbeck General Hospital

Ashington, Northumbria, United Kingdom

Scarborough Hospital

Scarborough, Nortrh Yorkshire, United Kingdom

Nottingham City Hospital

Nottingham, Nottinghamshire, United Kingdom

The John Radcliffe Hospital

Oxford, Oxfordshire, United Kingdom

Aberdeen Royal Infirmary

Aberdeen, Scotland, United Kingdom

Royal Infirmary of Edinburgh

Edinburgh, Scotland, United Kingdom

Musgrove Park Hospital

Taunton, Somerset, United Kingdom

Northern General Hospital

Sheffield, South Yorkshire, United Kingdom

University Hospital of North Tees

Hardwick, Stockton-on-Tees, United Kingdom

Frimley Park Hospital

Camberley, Surrey, United Kingdom

Surrey & Sussex Healthcare NHS Trust

Redhill, Surrey, United Kingdom

University Hospital of Wales

Cardiff, Wales, United Kingdom

University Hospital Coventry

Coventry, Warwickshire, United Kingdom

New Cross Hospital

Wolverhampton, West Midlands, United Kingdom

St Richards Hospital

Chichester, West Sussex, United Kingdom

Leeds General Infirmary

Leeds, West Yorkshire, United Kingdom

Pinderfields Hospital

Wakefield, West Yorkshire, United Kingdom

Worcestershire Royal Hospital

Worcester, Worcestershire, United Kingdom

Wythenshaw Hospital

Manchester, Wythenshaw, United Kingdom

Castle Hill Hospital

Hull, Yorkshire, United Kingdom

Royal Devon & Exeter Hospital

Exeter, United Kingdom

Morriston Hospital

Swansea, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT05568069


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