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

RecruitingNAAges 18 Years - anyAllUniversity Hospital Southampton NHS Foundation Tr…
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In plain words

What the trial is, and whether it could suit you

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.

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
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
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What it tests

  • Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronisation Therapy Defibrillator (CRTD)
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Where

47 sites
Wycombe Hospital
High Wycombe, United Kingdom
Derriford Hospital
Plymouth, United Kingdom
Royal Bournemouth Hospital
Bournemouth, United Kingdom
Durham & Darlington NHS Foundation Trust
Darlington, United Kingdom
Royal Sussex County Hospital
Brighton, United Kingdom
Essex Cardiothoracic Centre
Basildon, United Kingdom
James Paget University Hospitals NHS FT
Gorleston-on-Sea, United Kingdom
Portsmouth Hospitals University NHS Trust
Portsmouth, United Kingdom

…and 39 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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