An interventional study of Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronisation Therapy Defibrillator (CRTD) in Heart Failure, sponsored by University Hospital Southampton NHS Foundation Trust. Recruiting at 47 sites in United Kingdom. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-16.
Sponsored by University Hospital Southampton NHS Foundation Trust · Not applicable, Interventional, and Treatment
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.
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 can correct these serious heart rhythms (Implantable Cardioverter-Defibrillator (ICD)). However, research studies have shown that 90% of patients who have an ICD will never use it because they won't experience any serious heart rhythms. A recent large trial (DANISH) of over one thousand patients with severe Non-Ischemic Cardiomyopathy has called the current guidelines into question. The trial concluded that for patients who received an ICD, there was no difference in the likelihood of dying when compared to patients that didn't have an ICD fitted. As a result, many doctors are choosing not to implant an ICD in patients with this type of heart failure, as they believe there is no overall survival benefit. However, there are clues that some patients with NICM may still benefit from an ICD, even though the headline results suggest they are not necessary. It's likely that it's the patients who are at increased risk of having a serious abnormal heart rhythm that stand to benefit from ICDs. But having an ICD fitted carries with it a significant risk of problems developing e.g. bleeding, infection, lead problems, and inappropriate shocks. These risks may not outweigh the benefits and it is this question which BRITISH will address. The study will randomly assign (like the toss of a coin), half the study participants to receive an ICD and the other half to no ICD.
Both groups will be followed up to decide whether having an ICD fitted reduces the chances of dying.
Exclusion Criteria:
ICD or CRTD fitted
Device: Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronisation Therapy Defibrillator (CRTD)
No ICD fitted (with Implantable Loop Recorder) or Cardiac Resynchronisation Therapy Pacemaker (CRTP)
Usual medical care
An ICD is a device that is implanted under the skin under a local anesthetic. It has a battery/generator component and leads which are fixed into the heart chambers. It has the ability to detect dangerous heart rhythms if they occur, and deliver a shock to treat this to help prevent sudden cardiac death. A CRTD is a pacemaker with a defibrillator function.
Percentage of patients alive
All-cause mortality
Time frame: 3 years
Change in health-related quality of life measured using KCCQ-12
Short questionnaire including questions related to heart failure symptoms and how they affect daily activities
Time frame: 3 years
Change in health-related quality of life measured using EQ-5D-5L
Questionnaire consisting of 5 questions to evaluate a patients quality of life
Time frame: 3 years
Cardiovascular Death
Percentage of patients that have cardiovascular death
Time frame: 3 years
Sudden cardiac death
Percentage of patients that have sudden cardiac death
Time frame: 3 years
Aborted sudden cardiac death
Percentage of patients that have aborted sudden cardiac death
Time frame: 3 years
Appropriate ICD Therapy
Percentage of patients that have appropriate ICD therapy
Time frame: 3 years
Inappropriate ICD Therapy
Percentage of patients that have inappropriate ICD therapy
Time frame: 3 years
Significant ventricular arrhythmias
Percentage of patients that have significant ventricular arrhythmias
Time frame: 3 years
NYHA Status
Percentage of patients in each category
Time frame: 3 years
Heart failure hospitalisations
Number of events
Time frame: 3 years
Cardiac hospitalisations
Number of events
Time frame: 3 years
Procedures related to implanted device
Number of events
Time frame: 3 years
Percentage of patients alive
Mortality
Time frame: At 5 and 10 years
Plan to share: No
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University Hospital Southampton NHS Foundation Trust