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RECRUITING

NCT05568069

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

Sponsor: University Hospital Southampton NHS Foundation Trust

View on ClinicalTrials.gov

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.

Official 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

Key Details

Gender

All

Age Range

18 Years - Any

Study Type

INTERVENTIONAL

Enrollment

2504

Start Date

2023-04-12

Completion Date

2036-04-01

Last Updated

2026-03-05

Healthy Volunteers

Conditions

Heart Failure

Interventions

DEVICE

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.

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 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

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