RCT of Implantable Defibrillators in Patients With Non Ischemic Cardiomyopathy, Scar and Severe Systolic Heart Failure
- Conditions
- Heart Failure
- Interventions
- Device: Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronisation Therapy Defibrillator (CRTD)
- Registration Number
- NCT05568069
- Brief 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.
- Detailed Description
Patients with Non-Ischemic Cardiomyopathy (NICM) have a higher risk of experiencing serious abnormal heart rhythms that might be life-threatening. Current guidelines recommend fitting a device that can correct these serious heart rhythms (Implantable Cardioverter-Defibrillator (ICD)). However, research studies have shown that 90% of patients who have an ICD will never use it because they won't experience any serious heart rhythms. A recent large trial (DANISH) of over one thousand patients with severe Non-Ischemic Cardiomyopathy has called the current guidelines into question. The trial concluded that for patients who received an ICD, there was no difference in the likelihood of dying when compared to patients that didn't have an ICD fitted. As a result, many doctors are choosing not to implant an ICD in patients with this type of heart failure, as they believe there is no overall survival benefit. However, there are clues that some patients with NICM may still benefit from an ICD, even though the headline results suggest they are not necessary. It's likely that it's the patients who are at increased risk of having a serious abnormal heart rhythm that stand to benefit from ICDs. But having an ICD fitted carries with it a significant risk of problems developing e.g. bleeding, infection, lead problems, and inappropriate shocks. These risks may not outweigh the benefits and it is this question which BRITISH will address. The study will randomly assign (like the toss of a coin), half the study participants to receive an ICD and the other half to no ICD.
Both groups will be followed up to decide whether having an ICD fitted reduces the chances of dying.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 2504
- 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
- New York Heart Association (NYHA) HF functional class IV after 3 months of optimal medical therapy (OMT)
- Acute decompensated heart failure
- Previous implantable device in situ (PPM, Cardiac Resynchronisation Therapy (CRT) or ICD)
- 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)
- Known diagnosis of amyloidosis, sarcoidosis, arrhythmogenic right ventricular cardiomyopathy, or hypertrophic cardiomyopathy (diseases in which there are specific guidelines regarding defibrillator therapy)
- Known Lamin gene mutation or a positive family history of a Lamin gene mutation
- Valve disease is considered likely to require surgery during the 3 years follow-up period
- Complex congenital heart disease
- Any secondary prevention ICD indication
- Heart transplant recipient or admitted for cardiac transplantation/ left ventricular assist device
- Clinically apparent myocardial ischemia which requires revascularization
- Intracardiac mass which requires surgery
- Active endocarditis
- Active Septicaemia
- Pregnancy
- Life expectancy <2 years secondary to any other cause (i.e. malignancy)
- Active treatment with chemotherapy
- Severe renal failure (GFR <30)
- Actively participating in another study without prior agreement between both Chief Investigators
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronisation Therapy Defibrillator (CRTD) ICD or CRTD fitted
- Primary Outcome Measures
Name Time Method Percentage of patients alive 3 years All-cause mortality
- Secondary Outcome Measures
Name Time Method Change in health-related quality of life measured using KCCQ-12 3 years Short questionnaire including questions related to heart failure symptoms and how they affect daily activities
Change in health-related quality of life measured using EQ-5D-5L 3 years Questionnaire consisting of 5 questions to evaluate a patients quality of life
Cardiovascular Death 3 years Percentage of patients that have cardiovascular death
Sudden cardiac death 3 years Percentage of patients that have sudden cardiac death
Aborted sudden cardiac death 3 years Percentage of patients that have aborted sudden cardiac death
Appropriate ICD Therapy 3 years Percentage of patients that have appropriate ICD therapy
Inappropriate ICD Therapy 3 years Percentage of patients that have inappropriate ICD therapy
Significant ventricular arrhythmias 3 years Percentage of patients that have significant ventricular arrhythmias
NYHA Status 3 years Percentage of patients in each category
Heart failure hospitalisations 3 years Number of events
Cardiac hospitalisations 3 years Number of events
Procedures related to implanted device 3 years Number of events
Percentage of patients alive At 5 and 10 years Mortality
Trial Locations
- Locations (37)
Essex Cardiothoracic Centre
🇬🇧Basildon, Essex, United Kingdom
Wycombe Hospital
🇬🇧High Wycombe, Buckinghamshire, United Kingdom
Newcastle Freeman Hospital
🇬🇧Newcastle, Newcastle Upon Tyne, United Kingdom
The James Cook University Hospital
🇬🇧Middlesbrough, North Yorkshire, United Kingdom
Kent & Canterbury Hospital
🇬🇧Canterbury, Kent, United Kingdom
Durham & Darlington NHS Foundation Trust
🇬🇧Darlington, Durham, United Kingdom
Royal Bournemouth Hospital
🇬🇧Bournemouth, Dorset, United Kingdom
James Paget University Hospitals NHS FT
🇬🇧Gorleston-on-Sea, Great Yarmouth, United Kingdom
Blackpool Victoria Hospiatal
🇬🇧Blackpool, Lancashire, United Kingdom
St George's Hospital
🇬🇧Tooting, London, United Kingdom
Scarborough Hospital
🇬🇧Scarborough, Nortrh Yorkshire, United Kingdom
Wansbeck General Hospital
🇬🇧Ashington, Northumbria, United Kingdom
Northern General Hospital
🇬🇧Sheffield, South Yorkshire, United Kingdom
New Cross Hospital
🇬🇧Wolverhampton, West Midlands, United Kingdom
Royal Devon & Exeter Hospital
🇬🇧Exeter, United Kingdom
Leeds General Infirmary
🇬🇧Leeds, West Yorkshire, United Kingdom
Pinderfields Hospital
🇬🇧Wakefield, West Yorkshire, United Kingdom
St Bartholomew's Hospital
🇬🇧London, United Kingdom
King's College Hospital
🇬🇧London, United Kingdom
Morriston Hospital
🇬🇧Swansea, United Kingdom
Portsmouth Hospitals University NHS Trust
🇬🇧Portsmouth, Hampshire, United Kingdom
Southampton Clinical Trials Unit
🇬🇧Southampton, Hampshire, United Kingdom
The John Radcliffe Hospital
🇬🇧Oxford, Oxfordshire, United Kingdom
Derriford Hospital
🇬🇧Plymouth, Devon, United Kingdom
Liverpool Heart & Chest
🇬🇧Liverpool, Lancashire, United Kingdom
University Hospital Southampton NHS Foundation Trust
🇬🇧Southampton, Hampshire, United Kingdom
Glenfield Hospital
🇬🇧Leicester, Leicestershire, United Kingdom
Nottingham City Hospital
🇬🇧Nottingham, Nottinghamshire, United Kingdom
Worcestershire Royal Hospital
🇬🇧Worcester, Worcestershire, United Kingdom
Musgrove Park Hospital
🇬🇧Taunton, Somerset, 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
Aberdeen Royal Infirmary
🇬🇧Aberdeen, Scotland, United Kingdom
Royal Infirmary of Edinburgh
🇬🇧Edinburgh, Scotland, United Kingdom
Guy's Hospital
🇬🇧London, United Kingdom
Royal Brompton Hospital
🇬🇧London, United Kingdom