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:

  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

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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Page 1 of 12 (47 locations)

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