BRITISH

Title

Using cardiovascular magnetic resonance identified scar as the Benchmark Risk Identification Tool for Implantable cardioverter defibrillators in patients with Non-Ischemic Cardiomyopathy and Severe systolic Heart failure.

Description

Current evidence provides a robust case for the further investigation of the notion that it is presence of scar in Non-Ischaemic Cardiomyopathy (NICM) patients with severely impaired systolic function (LVEF ≤35%) rather than purely impaired systolic function that should determine the risk for malignant tachyarrhythmia and it is therefore a plausible risk stratified marker for therapeutic benefit of ICD therapy.

Patients diagnosed with NICM, who have the presence of ventricular scar and severely impaired left ventricular function will be randomised in a controlled fashion between two arms – Arm A (ICD implantation) and Arm B (No ICD implantation). Patients randomised to Arm B will have an ILR implanted for safety. BRITISH aims to recruit 1252 patients over 3 years.

In addition, 1252 patients will be recruited to an observational registry which will run in parallel to the RCT arms of BRITISH and will include selected patients with non-ischemic cardiomyopathy (NICM) who are not eligible for recruitment into the main BRITISH trial. This registry population will provide a reference perspective for the main trial by specifically including patients with LVEF≤ 35% and no scar.

Objectives

Primary:

• To determine, in a randomised controlled fashion, whether the presence of scar (detected using CMR) as the arbiter of ICD therapy leads to lower all-cause mortality at 3 years (from last patient recruited)

Secondary:

• To compare clinical outcomes between the two groups at 3 years
• To compare the effect on general wellbeing between the two groups at 3 years

Trial Design

Multicentre, 2-arm randomised controlled trial.

Trial Status

In set-up

Population

Patients diagnosed with:

• non-ischaemic cardiomyopathy
• severely impaired left ventricular function (LVEF<35%)
• the presence of CMR-detected ventricular scar

Funder

This trial is funded by a grant from the British Heart Foundation