RCT of Implantable Defibrillators in Patients With Non Ischemic Cardiomyopathy, Scar and Severe S… (NCT05568069) | Clinical Trial Compass
RecruitingNot Applicable
RCT of Implantable Defibrillators in Patients With Non Ischemic Cardiomyopathy, Scar and Severe Systolic Heart Failure
United Kingdom2,504 participantsStarted 2023-04-12
Plain-language 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. 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.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
What they're measuring
1
Percentage of patients alive
Timeframe: 3 years
Trial details
NCT IDNCT05568069
SponsorUniversity Hospital Southampton NHS Foundation Trust
✕. 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