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RCT of Implantable Defibrillators in Patients With Non Ischemic Cardiomyopathy, Scar and Severe Systolic Heart Failure

Study acronym: BRITISH
StatusRecruiting
PhaseNot applicable
Started
View on ClinicalTrials.gov ↗

Record History

  1. Primary completion pushed from Oct 1, 2026 to Feb 28, 2029 Completion moved earlier from Apr 1, 2036 to Feb 28, 2032v10 Show 1 more changeShow less
    • Completion moved earlier from Apr 1, 2036 to Feb 28, 2032
  2. Primary completion date: Apr 1, 2026 to Oct 1, 2026 Site details revised at 1 of 47 sitesv9 Show 1 more changeShow less
    • Site details revised at 1 of 47 sites
  3. Study sites: 37 to 47v8
  4. Study sites: 34 to 37v7
  5. Site details revised at 1 of 34 sitesv6
Show 4 earlier versionsHide 4 earlier versions
  1. Study sites: 26 to 34v5
  2. Study sites: 17 to 26v4
  3. Trial status: Not Yet Recruiting to Recruiting Study sites: 1 to 17 · Start date changed from estimate of Apr 1, 2023 to Apr 12, 2023v3 Show 2 more changesShow less
    • Study sites: 1 to 17
    • Start date changed from estimate of Apr 1, 2023 to Apr 12, 2023
  4. Enrollment target: 1252 to 2504 Interventions: Implantable Cardioverter-Defibrillator (ICD) (Device) to Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronisation Therapy Defibrillator (CRTD) (Device) · Eligibility criteria expanded, about 7 words · Study description shortened, about 369 words · 2 morev2 Show 5 more changesShow less
    • Interventions: Implantable Cardioverter-Defibrillator (ICD) (Device) to Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronisation Therapy Defibrillator (CRTD) (Device)
    • Eligibility criteria expanded, about 7 words
    • Study description shortened, about 369 words
    • Study arms: 2 to 3
    • Study title shortened, about 5 words

    See this version in full on ClinicalTrials.gov ↗

  1. Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05568069
Lead Sponsor University Hospital Southampton NHS Foundation Trust
Collaborators: British Heart Foundation, University of Southampton
Conditions Heart Failure
Enrollment 2,504 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov