Home › Trials › NCT05568069

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

Using Cardiovascular Magnetic Resonance Identified Scar as the Benchmark Risk Indication Tool for Implantable Cardioverter Defibrillators in Patients With Non-Ischemic Cardiomyopathy and Severe Systolic Heart Failure

Not applicable Interventional University Hospital Southampton NHS Foundation Trust · NCT05568069

This study is testing whether getting an implantable defibrillator can help people with heart failure from non-ischemic cardiomyopathy live longer compared to those who don’t receive the device.

Quick facts

PhaseNot applicable
Study typeInterventional
Enrollment2504 (estimated)
Ages18 Years and up
SexAll
SponsorUniversity Hospital Southampton NHS Foundation Trust Academic / other
Drugs / interventionschemotherapy
Locations47 sites (High Wycombe, Buckinghamshire and 46 other locations)
Trial IDNCT05568069 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates for this study are patients diagnosed with Non-Ischemic Cardiomyopathy who have a left ventricular ejection fraction of 35% or less and are in NYHA functional classes I-III.

Not a fit: Patients with acute decompensated heart failure or those classified as NYHA functional class IV will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved management strategies for patients with Non-Ischemic Cardiomyopathy, potentially saving lives by identifying those who would benefit from an ICD.

How similar studies have performed: Previous studies, such as the DANISH trial, have raised questions about the efficacy of ICDs in similar populations, indicating that this trial is addressing a critical and potentially novel area of investigation.

Eligibility criteria

Show full inclusion / exclusion 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

Where this trial is running

High Wycombe, Buckinghamshire and 46 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Heart FailureCardiac Magnetic Resonance ImagingImplantable Cardioverter DeviceImplantable Loop RecorderLeft ventricular ejection fractionMyocardial scar
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.