Comparing implantable defibrillators in patients with heart failure from non-ischemic cardiomyopathy

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial, known as BRITISH, is a multicenter investigation in the UK focusing on patients diagnosed with heart failure due to Non-Ischemic Cardiomyopathy (NICM). Participants will be randomly assigned to receive either an Implantable Cardioverter-Defibrillator (ICD) or no device, with the primary aim of comparing all-cause mortality between the two groups over a period of 36 months and extending to 10 years. The study seeks to clarify the potential benefits of ICDs in patients who may be at risk for life-threatening heart rhythms, despite previous findings suggesting limited overall survival benefits. The results could significantly influence international treatment guidelines for heart failure management.

Why it matters

Who can join: the full rules

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

Where it's running

• Wycombe Hospital
  High Wycombe, Buckinghamshire, United Kingdom Recruiting
• Derriford Hospital
  Plymouth, Devon, United Kingdom Recruiting
• Royal Bournemouth Hospital
  Bournemouth, Dorset, United Kingdom Recruiting
• Durham & Darlington NHS Foundation Trust
  Darlington, Durham, United Kingdom Recruiting
• Royal Sussex County Hospital
  Brighton, East Sussex, United Kingdom Recruiting
• Essex Cardiothoracic Centre
  Basildon, Essex, United Kingdom Recruiting

Study contacts

• Study coordinator: Abigail Jones
• Email: a.b.p.jones@soton.ac.uk
• Phone: 023 8120 5154

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.