Status:
RECRUITING
RCT of Implantable Defibrillators in Patients With Non Ischemic Cardiomyopathy, Scar and Severe Systolic Heart Failure
Lead Sponsor:
University Hospital Southampton NHS Foundation Trust
Collaborating Sponsors:
British Heart Foundation
University of Southampton
Conditions:
Heart Failure
Eligibility:
All Genders
18+ years
Phase:
NA
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. Partic...
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 ca...
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Key Trial Info
Start Date :
April 12 2023
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
April 1 2036
Estimated Enrollment :
2504 Patients enrolled
Trial Details
Trial ID
NCT05568069
Start Date
April 12 2023
End Date
April 1 2036
Last Update
March 5 2026
Active Locations (47)
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1
Wycombe Hospital
High Wycombe, Buckinghamshire, United Kingdom, HP11 2TT
2
Derriford Hospital
Plymouth, Devon, United Kingdom, PL6 8DH
3
Royal Bournemouth Hospital
Bournemouth, Dorset, United Kingdom, BH7 7DW
4
Durham & Darlington NHS Foundation Trust
Darlington, Durham, United Kingdom, DL3 6HX