Heart FailureBRITISHNCT05568069
RCT of Implantable Defibrillators in Patients With Non Ischemic Cardiomyopathy, Scar and Severe Systolic Heart Failure
A study testing Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronisation Therapy Defibrillator (CRTD) in people with Heart Failure, run by University Hospital Southampton NHS Foundation Trust at 47 sites in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronisation Therapy Defibrillator (CRTD)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,504 participants
- Where
- 47 sitesUnited Kingdom
- Study dates
- 12 Apr 2023to 28 Feb 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
- 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
Show all 19Show fewer
- Valve disease is considered likely to require surgery during the 3 years follow-up period
- Complex congenital heart disease
- Any secondary prevention ICD indication
- Heart transplant recipient or admitted for cardiac transplantation/ left ventricular assist device
- Clinically apparent myocardial ischemia which requires revascularization
- Intracardiac mass which requires surgery
- Active endocarditis
- Active Septicaemia
- Pregnancy
- Life expectancy <2 years secondary to any other cause (i.e. malignancy)
- Active treatment with chemotherapy
- Severe renal failure (GFR <30)
- Actively participating in another study without prior agreement between both Chief Investigators
Trial locations and contacts
47 sites in 1 country. Contact the study team or a site near you to ask about taking part.
47 sites in 1 country
United Kingdom47 sites, 45 recruiting
- Recruiting
Aberdeen Royal Infirmary
Aberdeen, Scotland, AB25 2ZN
Dana Dawson, 03454566000
- Active, not recruiting
Wansbeck General Hospital
Ashington, Northumbria, NE63 9JJ
- Recruiting
Essex Cardiothoracic Centre
Basildon, Essex, SS16 5NL
Jason Dungu, 01268 524900
- Recruiting
Blackpool Victoria Hospiatal
Blackpool, Lancashire, FY3 8NR
Alison Seed, Dr, 01253 300000
- Recruiting
Royal Bournemouth Hospital
Bournemouth, Dorset, BH7 7DW
Chris Critoph, 01202 303626
- Recruiting
Royal Sussex County Hospital
Brighton, East Sussex, BN2 5BE
Steve Coombs, 01273 696955
- Recruiting
Frimley Park Hospital
Camberley, Surrey, GU16 7UJ
Lydia Sturridge, Dr, 0300 614 5000
- Recruiting
Kent & Canterbury Hospital
Canterbury, Kent, CT1 3NG
Steven White, 01227 766877
- Recruiting
University Hospital of Wales
Cardiff, Wales, CF14 4XW
Abbas Zaidi, 029 2074 7747
- Recruiting
St Richards Hospital
Chichester, West Sussex, PO19 6SE
Nick Child, 01243 788122
- Recruiting
University Hospital Coventry
Coventry, Warwickshire, CV2 2DX
Michael Kuehl, 024 7696 4000
- Recruiting
Durham & Darlington NHS Foundation Trust
Darlington, Durham, DL3 6HX
Darragh Twomey, MD, 01325380100
- Recruiting
Royal Infirmary of Edinburgh
Edinburgh, Scotland, EH16 4SA
Marc Dweck, 0131 536 1000
- Recruiting
Royal Devon & Exeter Hospital
Exeter, EX2 5DW
Andrew Ludman, Dr, 01392 411611
- Recruiting
James Paget University Hospitals NHS FT
Gorleston-on-Sea, Great Yarmouth, NR31 6LA
Sunil Nair, Dr, 01493 452452
- Recruiting
University Hospital of North Tees
Hardwick, Stockton-on-Tees, TS19 8PE
Matthew Dewhurst, Dr, 01642 617617
- Recruiting
Wycombe Hospital
High Wycombe, Buckinghamshire, HP11 2TT
Nadine Ali, Dr, 01494 425958
- Recruiting
Castle Hill Hospital
Hull, Yorkshire, HU16 5JQ
Antony Renjith, 01482 875875
- Recruiting
Leeds General Infirmary
Leeds, West Yorkshire, LS1 3EX
John Greenwood, 01132432799
- Recruiting
Glenfield Hospital
Leicester, Leicestershire, LE3 9QP
Ian Loke, 01268 524900
- Recruiting
Liverpool Heart & Chest
Liverpool, Lancashire, L14 3PE
Archie Rao, 0151 600 1616
- Recruiting
St Bartholomew's Hospital
London, London, EC1A 7BE
Kostas Savvatis, 0207 3777 000
- Recruiting
Royal Free Hospital
London, London, NW3 2QG
Gabriella Captur, 020 7794 0500
- Recruiting
Guy's Hospital
London, London, SE1 9RT
Anoop Shetty, 020 7188 7188
- Recruiting
King's College Hospital
London, London, SE5 9RS
Daniel Sado, Dr, 020 3299 9000
- Recruiting
Royal Brompton Hospital
London, London, SW3 6NP
Sanjay Prasad, MD, 02073528121
- Recruiting
Hammersmith Hospital, Imperial College Healthcare NHS Trust
London, London, Wq12 0HS
Graham Cole, 020 3313 1000
- Recruiting
Maidstone Hospital, Maidstone & Tunbridge Wells NHS Trust
Maidstone, Kent, ME16 9QQ
Laurence Nunn, 01622 729000
- Recruiting
Fairfield General Hospital, Northern Care Alliance NHS FT
Manchester, Manchester, BL9 7TD
Yuran Zheng, 0161 624 0420
- Recruiting
Wythenshaw Hospital
Manchester, Wythenshaw, M23 9LT
Niall Campbell, 0161 998 7070
- Recruiting
The James Cook University Hospital
Middlesbrough, North Yorkshire, TS4 3BW
Michael Chapman, Dr, 01642 850850
- Recruiting
Newcastle Freeman Hospital
Newcastle, Newcastle Upon Tyne, NE7 7DN
Hanney Gonna, MD, 01912336161
- Recruiting
Nottingham City Hospital
Nottingham, Nottinghamshire, NG5 1PB
Jenny Chuen, Dr, 0115 969 1169
- Recruiting
The John Radcliffe Hospital
Oxford, Oxfordshire, OX3 9DU
Julian Ormerod, Dr, 0300 304 7777
- Recruiting
Derriford Hospital
Plymouth, Devon, PL6 8DH
Ben Sieniewicz, Dr, 01752 202082
- Recruiting
Portsmouth Hospitals University NHS Trust
Portsmouth, Hampshire, PO6 3LY
Geraint Morton, 02392286000
- Recruiting
Surrey & Sussex Healthcare NHS Trust
Redhill, Surrey, RH1 5RH
Cheuk Chan, Dr, 01737 768511
- Recruiting
Scarborough Hospital
Scarborough, Nortrh Yorkshire, YO12 6QL
Daniel Swarbrick, Dr, 01723 368111
- Recruiting
Northern General Hospital
Sheffield, South Yorkshire, S5 7AU
Dominic Rogers, Dr, 0114 243 4343
- Not yet recruiting
Southampton Clinical Trials Unit
Southampton, Hampshire, SO16 6YD
Jacqui Nuttall, 023 8120 3866, J.Nuttall@soton.ac.uk
Zina Eminton, 023 8026 8125, Z.B.Eminton@soton.ac.uk
- Recruiting
University Hospital Southampton NHS Foundation Trust
Southampton, Hampshire, SO16 6YD
Andrew Flett, +44 (0)23 8120 8538, andrew.flett@uhs.nhs.uk
Zoe Nicholas, +44 (0)23 8120 8538, zoe.nicholas@uhs.nhs.uk
- Recruiting
Morriston Hospital
Swansea, SA6 6NL
Geraint Jenkins, 01792 702222
- Active, not recruiting
Musgrove Park Hospital
Taunton, Somerset, TA1 5DA
- Recruiting
St George's Hospital
Tooting, London, SW17 0QT
Fadi Jouhra, Dr, 02086721255
- Recruiting
Pinderfields Hospital
Wakefield, West Yorkshire, WF1 4DG
Peter Swaboda, 01924 541000
- Recruiting
New Cross Hospital
Wolverhampton, West Midlands, WV10 0QP
Anita Arya, 01902 307999
- Recruiting
Worcestershire Royal Hospital
Worcester, Worcestershire, WR5 1DD
David Wilson, Dr, 01905 763333
About this study
Official title: 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
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.
Read the detailed description
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.
- Conditions
- Heart Failure
- Being tested
- Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronisation Therapy Defibrillator (CRTD)
- Keywords
- Cardiac Magnetic Resonance Imaging (CMR), Implantable Cardioverter Device, Implantable Loop Recorder, Left ventricular ejection fraction (LVEF), Myocardial scar
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronisation Therapy Defibrillator (CRTD)Device
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.
| Study group | Role | What they receive |
|---|---|---|
| Intervention | Experimental | ICD or CRTD fitted Receives: Device: Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronisation Therapy Defibrillator (CRTD) |
| Control | No intervention | No ICD fitted (with Implantable Loop Recorder) or Cardiac Resynchronisation Therapy Pacemaker (CRTP) |
| Registry | No intervention | Usual medical care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of patients alive
All-cause mortality
Measured: 3 years
Secondary outcomes (13)
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
Measured: 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
Measured: 3 years
Cardiovascular Death
Percentage of patients that have cardiovascular death
Measured: 3 years
Sudden cardiac death
Percentage of patients that have sudden cardiac death
Measured: 3 years
Aborted sudden cardiac death
Percentage of patients that have aborted sudden cardiac death
Measured: 3 years
Appropriate ICD Therapy
Percentage of patients that have appropriate ICD therapy
Measured: 3 years
Inappropriate ICD Therapy
Percentage of patients that have inappropriate ICD therapy
Measured: 3 years
Significant ventricular arrhythmias
Percentage of patients that have significant ventricular arrhythmias
Measured: 3 years
NYHA Status
Percentage of patients in each category
Measured: 3 years
Heart failure hospitalisations
Number of events
Measured: 3 years
Cardiac hospitalisations
Number of events
Measured: 3 years
Procedures related to implanted device
Number of events
Measured: 3 years
Percentage of patients alive
Mortality
Measured: At 5 and 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2022
- Study start12 Apr 2023
- Primary completion28 Feb 2029 (estimated)
- Study completion28 Feb 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Eligible patients will be randomised in a controlled fashion into two arms (n=1252): Arm A: ICD implantation Arm B: No ICD implantation Patients with no scar on CMR will be followed up in a registry (n=1252)
- Masking
- None (open label)
- Enrolment
- 2,504 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Southampton NHS Foundation Trust
- Sponsor type
- University, hospital or other
- Collaborators
- British Heart Foundation, University of Southampton
- Responsible party
- Sponsor
- Investigators
- Andrew Flett, Study chair, University Hospital Southampton NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05568069
- Sponsor's protocol ID
- RHMCAR0581
- Acronym
- BRITISH
- Status last verified
- Jun 2026
- First submitted
- 27 Sep 2022
- Last updated
- 16 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT05568069
- Acronym / sponsor ID
- BRITISH / RHMCAR0581
- Conditions
- Heart Failure
- Keywords
- Cardiac Magnetic Resonance Imaging (CMR), Implantable Cardioverter Device, Implantable Loop Recorder, Left ventricular ejection fraction (LVEF), Myocardial scar
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,504 participants (estimated)
- Lead sponsor
- University Hospital Southampton NHS Foundation TrustUniversity, hospital or other
- Collaborators
- British Heart Foundation, University of Southampton
- Study start
- 12 Apr 2023 (actual)
- Primary completion
- 28 Feb 2029 (estimated)
- Study completion
- 28 Feb 2032 (estimated)
- First posted
- 5 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
- Model description
- Eligible patients will be randomised in a controlled fashion into two arms (n=1252): Arm A: ICD implantation Arm B: No ICD implantation Patients with no scar on CMR will be followed up in a registry (n=1252)
| Arm | Type | Receives |
|---|---|---|
| Intervention | Experimental | Device: Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronisation Therapy Defibrillator (CRTD)ICD or CRTD fitted |
| Control | No intervention | –No ICD fitted (with Implantable Loop Recorder) or Cardiac Resynchronisation Therapy Pacemaker (CRTP) |
| Registry | No intervention | –Usual medical care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (19 listed)
- 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)
- Known diagnosis of amyloidosis, sarcoidosis, arrhythmogenic right ventricular cardiomyopathy, or hypertrophic cardiomyopathy (diseases in which there are specific guidelines regarding defibrillator therapy)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronisation Therapy Defibrillator (CRTD)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. | Device | Intervention |
Primary outcome
Percentage of patients alive
Time frame: 3 years
All-cause mortality
13 secondary outcomes
Change in health-related quality of life measured using KCCQ-12
Time frame: 3 years
Change in health-related quality of life measured using EQ-5D-5L
Time frame: 3 years
Cardiovascular Death
Time frame: 3 years
Sudden cardiac death
Time frame: 3 years
Aborted sudden cardiac death
Time frame: 3 years
Appropriate ICD Therapy
Time frame: 3 years
Inappropriate ICD Therapy
Time frame: 3 years
Significant ventricular arrhythmias
Time frame: 3 years
NYHA Status
Time frame: 3 years
Heart failure hospitalisations
Time frame: 3 years
Cardiac hospitalisations
Time frame: 3 years
Procedures related to implanted device
Time frame: 3 years
Percentage of patients alive
Time frame: At 5 and 10 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Jun 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Andrew Flett study chair
University Hospital Southampton NHS Foundation Trust
47 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Implantable Cardioverter-Defibrillator (ICD) or Cardiac Resynchronisation Therapy Defibrillator (CRTD) in people with Heart Failure, run by University Hospital Southampton NHS Foundation Trust at 47 sites in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 16 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Abigail Jones (023 8120 5154, a.b.p.jones@soton.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of patients alive (time frame: 3 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Jun 2026.