BradycardiaPROTECT-HFNCT05815745
"Physiological vs Right Ventricular Pacing Outcome Trial Evaluated for bradyCardia Treatment" (PROTECT-HF)
A study testing Pacemaker - Physiological pacing and Pacemaker - Right Ventricular pacing in people with Bradycardia and Pacing, run by Imperial College London at 45 sites in 3 countries.
Trial summary
The PROTECT-HF multi-centre randomised controlled trial will compare two different pacing approaches for treating patients with slow heart rates. In it the investigators will compare a long-standing standard approach for pacing; right ventricular pacing, with a new form of pacing, physiological pacing (His and Left… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bradycardia, Pacing, Right Ventricular Pacing
- What is being tested?
- Pacemaker - Physiological pacing and Pacemaker - Right Ventricular pacing
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 2,600 participants
- Where
- 45 sitesin 3 countries
- Study dates
- 5 Jun 2023to 4 Jun 2031
- 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
- 1. Adults aged over 18 with left ventricular ejection fraction >35% and one or more of the following guideline based ventricular pacing indications:
- Permanent or intermittent 3rd degree AV block
- Permanent or intermittent Mobitz type II AV block
- First Degree AV block with a pacing indication
- Slow chronic Atrial Fibrillation or Proposed AV node ablation
- Bifascicular block with a pacing indication
- Trifascicular block with a pacing indication
- Wenckebach with a pacing indication
Who cannot join
- Patients who are likely to only need occasional ventricular pacing, i.e. those with isolated sick sinus syndrome.
- Pregnant women.
- Unable to provide informed consent.
- Those with comorbidity leading to a life expectancy <1year.
Trial locations and contacts
45 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
45 sites in 3 countries
United Kingdom43 sites, 43 recruiting
- Recruiting
Aberdeen Royal Infirmary
Aberdeen
Valerie Harris, valerie.harries@nhs.scot
Dr Santhosh Raga
- Recruiting
Queen's Hospital
Barking
Katrina Frayna, katrina.frayna@nhs.net
Dr Afzal Sohaib
- Recruiting
Good Hope Hospital
Birmingham
Daniel Lenton, daniel.lenton2@uhb.nhs.uk
Dr Hossam Elsayed
- Recruiting
Queen Elizabeth Hospital
Birmingham
Sophia Duong, Sophia.DuongVu@uhb.nhs.uk
Prof Francisco Levya
- Recruiting
University Hospital Dorset
Bournemouth
Tanith Changuion, Tanith.Changuion@uhd.nhs.uk
Dr Girish Ganesha Babu
- Recruiting
Royal SUSSEX County Hospital
Brighton
Fiona Ingoldby, fiona.ingoldby@nhs.net
Dr Susan Ellery
- Recruiting
Bristol Heart Institute
Bristol
Sheila Bell, sheila.bell@uhbw.nhs.uk
Jessica Strange, jessica.strange@uhbw.nhs.uk
- Recruiting
Royal Papworth Hospital
Cambridge
Joanna Oliveira, j.oliveira@nhs.net
Dr Sharad Agarwal
- Recruiting
St Richard's Hospital
Chichester
Katherine Nicholas, katherine.nicholas@nhs.net
Dr Mark Tanner
- Recruiting
University Hospital Coventry
Coventry
Nigel Edwards, Nigel.Edwards@uhcw.nhs.uk
Dr Michael Kuehl
- Recruiting
Croydon
Croydon
Jacqueline Adabie-Ankrah, jacquelineadabie-ankrah@nhs.net
Dr Ravi Kamdar
- Recruiting
Royal Infirmary of Edinburgh
Edinburgh
Marie Callaghan, Marie.Callaghan@nhslothian.scot.nhs.uk
Claire Hart, claire.hart@nhs.scot
- Recruiting
Victoria Hospital
Fife Keith
Sandra Pirie, sandra.pirie@nhs.scot
Dr Jagdeep Singh
- Recruiting
Medway Maritime Hospital
Gillingham
Suzanne Williams, suzanne.williams49@nhs.net
Dr Shaumik Adhya
- Recruiting
Wycombe Hospital
High Wycombe
Josephine Chaplin, josephine.chaplin@nhs.net
Dr Norman Qureshi
- Recruiting
Forth Valley Royal Hospital
Larbert
Elaine Wilson, elaine.wilson13@nhs.scot
Dr Gareth Padfield
- Recruiting
Leeds Teaching Hospital
Leeds
Marie Callaghan, marie.callaghan@nhslothian.scot.nhs.uk
Dr Muzahir Tayebjee
- Recruiting
Glenfield Hospital
Leicester
Elizabeth Cox, elizabeth.a.cox@uhl-tr.nhs.uk
Dr Mokhtar Ibrahim
- Recruiting
Liverpool Heart and Chest Hospital
Liverpool
Sharon Glynn, sharon.glynn@lhch.nhs.uk
Dr Archana Rao
- Recruiting
Hammersmith Hospital
London
Nandita Kaza, n.kaza@imperial.ac.uk
- Recruiting
Kettering Hospital
London
Eva Kisakye, e.kisakye@nhs.net
Dr Rachana Prasad
- Recruiting
King's College Hospital
London
Abigail Knighton, abigail.knighton@nhs.net
Dr Paul Scott
- Recruiting
Royal Free London/ Barnet Hospital
London
Susana Ramos Vasquez
susana.ramosvazquez@nhs.net
- Recruiting
St Bartholomew's Hospital
London
Ben Romano, ben.romano@nhs.net
Dr Phil Moore
- Recruiting
Watford General Hospital
London
Mary James, mary.james8@nhs.net
Dr Louisa Malcome Lawes
- Recruiting
James Cook Hospital
Middlesbrough
Beverly Atkinson, bevatkinson@nhs.net
Dr Mike Chapman
- Recruiting
King's Mill Hospital
Nottingham
Rebecca Rudd, rebecca.rudd4@nhs.net
Dr Sukh Bassi
- Recruiting
Nottingham City Hospital
Nottingham
Edelline Makondo, Edelline.Makondo@nuh.nhs.uk
Dr Phil Moore
- Recruiting
John Radcliffe Hospital
Oxford
Katharine New, KATHARINE.NEW@OUH.NHS.UK
Dr Julian Ormerod
- Recruiting
Derriford Hospital
Plymouth
Lorraine Madziva, lorraine.madziva1@nhs.net
Dr Edward Davies
- Recruiting
Queen Alexandra Hospital
Portsmouth
Pedro Bragasardo, pedro.bragasardo@porthosp.nhs.uk
Dr Senthil Kirubakaran
- Recruiting
Royal Berkshire
Reading
Mark Brunton, Mark.brunton@royalberkshire.nhs.uk
Dr Jon Swinburn
- Recruiting
East Surrey
Redhill
Julie Houghton, julie.houghton15@nhs.net
Dr Cheuk Chan
- Recruiting
Rotherham General Hospital
Rotherham
Rachel Walker, rachel.walker7@nhs.net
Dr Simon Smith
- Recruiting
Northern General
Sheffield
Olivia Holmes, olivia.holmes3@nhs.net
Dr Nigel Lewis
- Recruiting
Wexham Park Hospital
Slough
Victoria Ugochukwu, victoria.ugochukwu@nhs.net
Dr Sofia Metaxa
- Recruiting
Southampton
Southampton
Lisa Fletcher, Lisa.Fletcher@uhs.nhs.uk
Dr John Paisley
- Recruiting
Morriston Hospital
Swansea
Debbie Williams, Debbie.Williams8@wales.nhs.uk
Dr Dewi Thomas
- Recruiting
Great Western
Swindon
Suzannah Pegler, suzannah.pegler1@nhs.net
Dr Badri Chandrasekaran
- Recruiting
Musgrove Park Hospital
Taunton
Helen Mills, helen.mills@somersetft.nhs.uk
Dr Guy Furniss
- Recruiting
Torbay Hospital
Torquay
Lisa Felmelden, lisa.felmeden@nhs.net
Dr Lisa Yung
- Recruiting
UHS Worthing
Worthing
Samantha Margerison, samantha.margerison@nhs.net
Dr Marian Bencat
- Recruiting
York Hospital
York
Julie Anderson, julie.anderson3@nhs.net
Dr Chris Hayes
Ireland1 site, 1 recruiting
- Recruiting
Beacon Hospital
Dublin
Dr Cian Mangan, Cian.Mangan@beaconhospital.ie
Prof Jonathan Lyne
Slovenia1 site, 1 recruiting
- Recruiting
Univerisity Medical Centre Ljubljana
Ljubljana
Dr David Zizek, david.zizek@kclj.si
Dr David Zizek
About this study
Official title: Physiological vs Right Ventricular Pacing Outcome Trial Evaluated for bradyCardia Treatment
The PROTECT-HF multi-centre randomised controlled trial will compare two different pacing approaches for treating patients with slow heart rates. In it the investigators will compare a long-standing standard approach for pacing; right ventricular pacing, with a new form of pacing, physiological pacing (His and Left bundle area pacing) in 2600 patients.
Patients will be allocated at random to receive either right ventricular pacing or physiological pacing. Endpoint measurements will be undertaken at baseline, and at six-monthly intervals post-randomisation. Treatment allocation will be blinded to the endpoint assessor and the patient.
Read more
Recruitment and pacemaker implantation will be carried out at each participating centre. The primary analysis will be intention to treat. The investigators will also perform an on-treatment analysis.
2048 patients are needed to detect the expected effect size with 85% power. A total of 2600 patients will be recruited to allow for patient drop-out and crossover.
500-patient sub-study will assess within patient, and between groups, echocardiographic changes over a 24-month period to try and improve mechanistic understanding of PICM (Pacing Induced Cardiomyopathy).
Read the detailed description
Patients entering the study will attend for implantation of a pacemaker device and be randomised to either right ventricular pacing or physiological pacing.
Patients at sites participating in echo sub-study will be informed of and given opportunity to consent to echo sub-study, this will be optional to them, even if they have consented to the main study.
- Conditions
- Bradycardia, Pacing, Right Ventricular Pacing, His Bundle Pacing, Left Bundle Branch Area Pacing
- Being tested
- Pacemaker - Physiological pacing, Pacemaker - Right Ventricular pacing
- Medical subject headings
- Bradycardia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Pacemaker - Physiological pacingDevice
The approach for physiological pacing will be either His bundle pacing or left bundle pacing at the operator's discretion. If both of these are not achieved biventricular pacing will be performed.
Pacemaker - Right Ventricular pacingDevice
Right ventricular pacing (apical or septal lead locations as per the implanting physicians' normal practice).
| Study group | Role | What they receive |
|---|---|---|
| Right ventricular pacing | Active comparator | Right ventricular pacing (apical or septal lead locations as per the implanting physicians' normal practice) Receives: Device: Pacemaker - Right Ventricular pacing |
| Physiological pacing | Experimental | The approach for physiological pacing will be either His bundle pacing or left bundle pacing at the operator's discretion. If both of these are not achieved biventricular pacing will be performed. Receives: Device: Pacemaker - Physiological pacing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mortality
Death, any cause
Measured: From date of consent, until date of death from any cause, assessed up until 78 months.
Heart Failure Morbidity
Adjudicated unplanned heart failure acute care (hospital admissions or ambulatory diuretic therapy i.e. diuretic lounge visit).
Measured: From date of consent, assessed up until 78 months, or death from any cause, whichever came first.
Secondary outcomes (10)
Incidence of clinically indicated upgrade to conventional biventricular pacing (CRT device)
Measured: From date of randomisation until the date of first documented incident of device upgrade, or death from any cause, whichever came first, assessed up to 78 months.
Patient quality of life assessed via questionnaires (EQ-5D-5L) EQ-5D is the name of the instrument and is not an acronym.
The EQ-5D-5L consists of 2 pages: the EQ-5D descriptive system and the EQ 'visual analogue scale' (EQ VAS).
The descriptive system is made up of 5 sections: mobility, self-care, usual activities, pain/discomfort and anxiety/depression. Each has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
A High score on the descriptive section means a worse health outcome. A Low score on the descriptive section means a better health outcome. A value set is required to convert the outcomes into scores.
The EQ VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'. The VAS can be used as a quantitative (numerical) measure of health outcome that reflect the patient's own judgement.
A high score on the VAS means a better outcome. A low score on the VAS means a worse outcome.
Measured: From date of consent, assessed up to 78 months or until death of any cause, whichever came first.
Patient symptoms assessed on a scale of 0-100 monthly
This questionnaire will be sent to participants on a monthly basis for the duration of the study, 78 months from one month post pacemaker implant until end of study (78 months) or death from any cause, whichever came first.
Measured: From one month after device implant date, assessed up to 78 months or until death of any cause, whichever came first.
Safety endpoints: Device infections (requiring device extraction), pacing thresholds, need for lead revision or reimplantation, generator change, haematoma and pneumothorax
Measured: From device implant date, assessed up to 78 months or until death of any cause, whichever came first.
Pacemaker derived endpoints: a) Atrial fibrillation (duration >6minutes) b) Ventricular arrhythmia incidence c) Daily patient activity (hours stratified by device vendor)
Measured: From device implant date, assessed up to 78 months or until death of any cause, whichever came first.
Patient quality of life assessed via questionnaires '36-Item Short Form Health Survey' (SF-36)
A high score defines a more favourable health state. Range 0 to 100.
Measured: From date of consent, assessed up to 78 months or until death of any cause, whichever came first.
Echo Sub-Study Endpoint: Left Ventricular End Systolic Volume (LVESV) (>10mls) within group differences
Within group differences of Left Ventricular End Systolic Volume (>10mls) for differences according to treatment allocation.
Measured: From baseline echocardiogram (0 to 6 weeks post pacemaker implant) to follow-up echocardiogram (24±1 months post pacemaker implant).
Echo Sub-Study Endpoint: Ejection Fraction (EF) within patient changes
Within patient changes in Ejection Fraction will be assessed for differences according to treatment allocation.
Measured: From baseline echocardiogram (0 to 6 weeks post pacemaker implant) to follow-up echocardiogram (24±1 months post pacemaker implant).
Echo Sub-Study Endpoint: Left Ventricular End Systolic Volume (LVESV) (>10mls) within patient changes
Within patient changes of Left Ventricular End Systolic Volume (>10mls) for differences according to treatment allocation
Measured: From baseline echocardiogram (0 to 6 weeks post pacemaker implant) to follow-up echocardiogram (24±1 months post pacemaker implant).
Echo Sub-Study Endpoint: Ejection Fraction (EF) within group differences
Within group differences in Ejection Fraction will be assessed for differences according to treatment allocation.
Measured: From baseline echocardiogram (0 to 6 weeks post pacemaker implant) to follow-up echocardiogram (24±1 months post pacemaker implant).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Apr 2023
- Study start5 Jun 2023
- Primary completion4 Jun 2031 (estimated)
- Study completion4 Jun 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for BradycardiaStudies of the same condition, open and under way.
- More trials run by Imperial College LondonThe sponsor's other registered studies.
- 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
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 2,600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London
- Sponsor type
- University, hospital or other
- Collaborators
- British Heart Foundation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05815745
- Sponsor's protocol ID
- 22HH7931
- Acronym
- PROTECT-HF
- Status last verified
- Jul 2026
- First submitted
- 13 Feb 2023
- Last updated
- 22 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physiological vs Right Ventricular Pacing Outcome Trial Evaluated for bradyCardia Treatment
- ClinicalTrials.gov ID
- NCT05815745
- Acronym / sponsor ID
- PROTECT-HF / 22HH7931
- Conditions
- Bradycardia, Pacing, Right Ventricular Pacing, His Bundle Pacing, Left Bundle Branch Area Pacing
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 2,600 participants (estimated)
- Lead sponsor
- Imperial College LondonUniversity, hospital or other
- Collaborators
- British Heart Foundation
- Study start
- 5 Jun 2023 (actual)
- Primary completion
- 4 Jun 2031 (estimated)
- Study completion
- 4 Jun 2031 (estimated)
- First posted
- 18 Apr 2023 (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.
The PROTECT-HF multi-centre randomised controlled trial will compare two different pacing approaches for treating patients with slow heart rates. In it the investigators will compare a long-standing standard approach for pacing; right ventricular pacing, with a new form of pacing, physiological pacing (His and Left bundle area pacing) in 2600 patients.
Patients will be allocated at random to receive either right ventricular pacing or physiological pacing. Endpoint measurements will be undertaken at baseline, and at six-monthly intervals post-randomisation. Treatment allocation will be blinded to the endpoint assessor and the patient.
Recruitment and pacemaker implantation will be carried out at each participating centre. The primary analysis will be intention to treat. The investigators will also perform an on-treatment analysis.
2048 patients are needed to detect the expected effect size with 85% power. A total of 2600 patients will be recruited to allow for patient drop-out and crossover.
500-patient sub-study will assess within patient, and between groups, echocardiographic changes over a 24-month period to try and improve mechanistic understanding of PICM (Pacing Induced Cardiomyopathy).
Detailed description
Patients entering the study will attend for implantation of a pacemaker device and be randomised to either right ventricular pacing or physiological pacing.
Patients at sites participating in echo sub-study will be informed of and given opportunity to consent to echo sub-study, this will be optional to them, even if they have consented to the main study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Right ventricular pacing | Active comparator | Device: Pacemaker - Right Ventricular pacingRight ventricular pacing (apical or septal lead locations as per the implanting physicians' normal practice) |
| Physiological pacing | Experimental | Device: Pacemaker - Physiological pacingThe approach for physiological pacing will be either His bundle pacing or left bundle pacing at the operator's discretion. If both of these are not achieved biventricular pacing will be performed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 1. Adults aged over 18 with left ventricular ejection fraction >35% and one or more of the following guideline based ventricular pacing indications:
- Permanent or intermittent 3rd degree AV block
- Permanent or intermittent Mobitz type II AV block
- First Degree AV block with a pacing indication
- Slow chronic Atrial Fibrillation or Proposed AV node ablation
Key exclusion criteria (4 listed)
- Patients who are likely to only need occasional ventricular pacing, i.e. those with isolated sick sinus syndrome.
- Pregnant women.
- Unable to provide informed consent.
- Those with comorbidity leading to a life expectancy <1year.
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 |
|---|---|---|
| Pacemaker - Physiological pacingThe approach for physiological pacing will be either His bundle pacing or left bundle pacing at the operator's discretion. If both of these are not achieved biventricular pacing will be performed. | Device | Physiological pacing |
| Pacemaker - Right Ventricular pacingRight ventricular pacing (apical or septal lead locations as per the implanting physicians' normal practice). | Device | Right ventricular pacing |
Primary outcome
Mortality
Time frame: From date of consent, until date of death from any cause, assessed up until 78 months.
Death, any cause
Heart Failure Morbidity
Time frame: From date of consent, assessed up until 78 months, or death from any cause, whichever came first.
Adjudicated unplanned heart failure acute care (hospital admissions or ambulatory diuretic therapy i.e. diuretic lounge visit).
10 secondary outcomes
Incidence of clinically indicated upgrade to conventional biventricular pacing (CRT device)
Time frame: From date of randomisation until the date of first documented incident of device upgrade, or death from any cause, whichever came first, assessed up to 78 months.
Patient quality of life assessed via questionnaires (EQ-5D-5L) EQ-5D is the name of the instrument and is not an acronym.
Time frame: From date of consent, assessed up to 78 months or until death of any cause, whichever came first.
Patient symptoms assessed on a scale of 0-100 monthly
Time frame: From one month after device implant date, assessed up to 78 months or until death of any cause, whichever came first.
Safety endpoints: Device infections (requiring device extraction), pacing thresholds, need for lead revision or reimplantation, generator change, haematoma and pneumothorax
Time frame: From device implant date, assessed up to 78 months or until death of any cause, whichever came first.
Pacemaker derived endpoints: a) Atrial fibrillation (duration >6minutes) b) Ventricular arrhythmia incidence c) Daily patient activity (hours stratified by device vendor)
Time frame: From device implant date, assessed up to 78 months or until death of any cause, whichever came first.
Patient quality of life assessed via questionnaires '36-Item Short Form Health Survey' (SF-36)
Time frame: From date of consent, assessed up to 78 months or until death of any cause, whichever came first.
Echo Sub-Study Endpoint: Left Ventricular End Systolic Volume (LVESV) (>10mls) within group differences
Time frame: From baseline echocardiogram (0 to 6 weeks post pacemaker implant) to follow-up echocardiogram (24±1 months post pacemaker implant).
Echo Sub-Study Endpoint: Ejection Fraction (EF) within patient changes
Time frame: From baseline echocardiogram (0 to 6 weeks post pacemaker implant) to follow-up echocardiogram (24±1 months post pacemaker implant).
Echo Sub-Study Endpoint: Left Ventricular End Systolic Volume (LVESV) (>10mls) within patient changes
Time frame: From baseline echocardiogram (0 to 6 weeks post pacemaker implant) to follow-up echocardiogram (24±1 months post pacemaker implant).
Echo Sub-Study Endpoint: Ejection Fraction (EF) within group differences
Time frame: From baseline echocardiogram (0 to 6 weeks post pacemaker implant) to follow-up echocardiogram (24±1 months post pacemaker implant).
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 22 Jul 2026.
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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.
45 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Pacemaker - Physiological pacing and Pacemaker - Right Ventricular pacing in people with Bradycardia and Pacing, run by Imperial College London at 45 sites in 3 countries.
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 8 inclusion and 4 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 22 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 45 sites in United Kingdom, Ireland, Slovenia. 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 Zachary Whinnett (+447749576830, z.whinnett@imperial.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mortality (time frame: From date of consent, until date of death from any cause, assessed up until 78 months.). The study lists 2 primary outcomes in all. 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 22 Jul 2026.