Infective EndocarditisNCT06434012
Barts Endocarditis Research Registry
An observational study of Infective Endocarditis and Endocarditis, run by Queen Mary University of London at 1 site in United Kingdom.
Trial summary
The Barts Endocarditis Research Registry is being set up to give a unique opportunity to assess the characteristics of Infective Endocarditis (IE) in our population cohort, the current use of imaging techniques, as well as the implementation of the ESC guidelines and its consequence in terms of prognosis. Read more about this study
- Who is it for?
- Ages 16 years and older
- Conditions the study is for
- Infective Endocarditis, Endocarditis, Endocarditis, Bacterial
- What is being tested?
- registry
- How many people
- 1,000 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 24 Apr 2019to 30 Apr 2029
- Phase
- Observational
- 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 16 years and older
- All sexes
- Child, Adult, Older adult
Study population: There are approximately 150 cases of endocarditis each year treated within the trust and recruitment is expected to be rapid
Who may be able to join
- • Patients aged 16 and over (Patients under 16 years of age are not admitted to Barts Heart Centre)
- Patients admitted to Barts Heart Centre with confirmed Endocarditis (see above)
- Patients attending outpatients with confirmed/suspected Endocarditis
- Patients with possible IE who complete treatment for endocarditis
- Patients with cardiac device related Endocarditis
- Patients with the ability to provide informed consent
Who cannot join
- • Patients with pacemaker pocket infection with no evidence of pacemaker lead or valve infection
- Patients who refuse consent to be included in the research database
- Patients with "rejected" endocarditis
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Simon Woldman contact
United Kingdom1 site, 1 recruiting
- Recruiting
St Bartholomews Hospital
London
Innocent Bvekerwa, MSc, 07852209005, i.bvekerwa@nhs.net
Simon Woldman, simon.woldman@nhs.net
About this study
The Barts Endocarditis Research Registry is being set up to give a unique opportunity to assess the characteristics of Infective Endocarditis (IE) in our population cohort, the current use of imaging techniques, as well as the implementation of the ESC guidelines and its consequence in terms of prognosis. All this will help improve the diagnosis and management of IE. The registry will also form the core of all our subsequent work, including interventional studies. The endocarditis research registry is to record the epidemiological, demographic, microbiological, surgical and outcome data in our cohort of endocarditis patients. This work will underpin all future work in endocarditis by clearly defining our patient cohort and the outcomes from treatment. We have a series of studies planned that we believe will influence the management of endocarditis (we are working up proposals for genomic and therapeutic trials that will subsequently be presented for ethical and hospital approval). The registry will be generic to all our planned studies, and will allow us to capture data to assess treatment effectiveness
Read the detailed description
This research registry will give us the unique opportunity to assess the characteristics of IE in our population cohort, the current use of imaging techniques, as well as the implementation of the ESC guidelines and its consequence in terms of prognosis. All this will help improve the diagnosis and management of IE. The registry will also form the core of all our subsequent work, including interventional studies.
Infective endocarditis (IE) is a rare but serious disease, associated with high morbidity and in-hospital mortality. Despite improvements in diagnostic and therapeutic strategies the mortality remains at 15-30% in most published studies. The reasons for this persistent poor prognosis are numerous and include older patients with more severe disease, changes in the epidemiologic profiles and more patients with prosthetic or device related IE.
Following the formation of Barts Heart Centre (BHC) there was a sharp and noticeable increase in the number of patients with infective endocarditis (IE) referred to our centre. Recognising this change, the complexity of patients, and the coincident publication of the European Society of Cardiology Guidelines on Infective Endocarditis (2015), our Specialised Cardiology Directorate set up a new referral pathway, Standard Operating Procedure and Endocarditis Team meeting (MDT). The aim was to ensure focussed, consistent, and evidence-based care with joint medical and surgical input to this unique group of very unwell patients, with high inpatient mortality. In addition, the MDT would discuss and co-ordinate the care of all IE patients, with a weekly discussion of those on site, as well as at our referring hospitals. The MDT started in October 2015 and is composed of representatives from Cardiology (including imaging), Cardiac Surgery, Microbiology, Radiology/Nuclear Medicine and Pharmacy.
Since its inception, the MDT has discussed 367 patients at BHC and our wider referral centres (October 2015 - January 2018). Of those patients, 298 have been confirmed/probable as having IE: 144 surgically managed; 139 medically managed; 16 device extractions with intracardiac infection, all following international guidance. This does not include the grown-up congenital heart disease patients who are discussed and managed separately.
An audit database to track outcomes was started in January 2018, but there is a need to expand this work and make a registry that will form the foundation of all other research that we will undertake.
Mortality across the cohort has been at the lower end of international publications at 17.1% (51/298). Our current surgical mortality stands at 4.7% (14/298), which represents a significant reduction compared to pre-merger where combined mortality at the individual hospitals was 12.2%. In those patients who have died with medical management (37/51), the vast majority have had advanced life-limiting non-cardiac co-morbidities that preclude cardiac surgery (n=19) or on-going intravenous drug use after previous cardiac surgery for IE (n=6). Six patients have not been referred in time for surgery, having presented locally with septic shock and deteriorated rapidly, and this is an area of further education for our referring centres. Six patients have had operations without intra-operative evidence of infection. However, these patients had indications for surgery due to haemodynamically significant regurgitant valve disease.
Our morbidity and mortality reviews have allowed us to learn from all these cases, across all specialties and imaging modalities.
Not only has this approach led to improvements in patient care, but it has also raised the profile of BHC as a centre of special expertise. Our referring centres now include the DGH's of Barts Health NHS Trust (Whipps Cross University Hospital, Newham University Hospital, and The Royal London Hospital), plus many other district general hospitals in our locale.
- Being tested
- registry
- Medical subject headings
- Endocarditis, Endocarditis, Bacterial
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
registryOther
This is registry for Infective Endocarditis
What is being measured
The primary outcome is the main question the study is designed to answer.
To define current mortality rates for patients treated for endocarditis at Barts Heart Centre
The primary goal of the endocarditis registry is to record the epidemiological, demographic, microbiological, surgical and outcome data in our cohort of endocarditis patients. This work will underpin all future work in endocarditis by clearly defining our patient cohort and the outcomes from treatment.
Measured: 10 years
To define current morbidity rates for patients treated for endocarditis at Barts Heart Centre
The primary goal of the endocarditis registry is to record the epidemiological, demographic, microbiological, surgical and outcome data in our cohort of endocarditis patients. This work will underpin all future work in endocarditis by clearly defining our patient cohort and the outcomes from treatment.
Measured: 10 years
To define current rates of reinfection for patients treated for endocarditis at Barts Heart Centre
The primary goal of the endocarditis registry is to record the epidemiological, demographic, microbiological, surgical and outcome data in our cohort of endocarditis patients. This work will underpin all future work in endocarditis by clearly defining our patient cohort and the outcomes from treatment.
Measured: 10 years
To define current rates of relapse for patients treated for endocarditis at Barts Heart Centre
The primary goal of the endocarditis registry is to record the epidemiological, demographic, microbiological, surgical and outcome data in our cohort of endocarditis patients. This work will underpin all future work in endocarditis by clearly defining our patient cohort and the outcomes from treatment.
Measured: 10 years
Secondary outcomes (4)
To collect data regarding infecting organism, valve appearances and pathological markers and investigate their relationship to mortality, morbidity, reinfection and relapse rates
A secondary aim will be to use the registry to develop a series of observational studies, especially how the infecting organism interacts with the diagnostic indices in our labs and imaging protocols
Measured: 10 years
To collect data regarding infecting organism and investigate its relationship to mortality, morbidity, reinfection and relapse rates
A secondary aim will be to use the registry to develop a series of observational studies, especially how the infecting organism interacts with the diagnostic indices in our labs and imaging protocols
Measured: 10 years
To collect data regarding valve appearance and investigate its relationship to mortality, morbidity, reinfection and relapse rates
A secondary aim will be to use the registry to develop a series of observational studies, especially how the infecting organism interacts with the diagnostic indices in our labs and imaging protocols
Measured: 10 years
To collect data regarding pathological markers and investigate its relationship to mortality, morbidity, reinfection and relapse rates
A secondary aim will be to use the registry to develop a series of observational studies, especially how the infecting organism interacts with the diagnostic indices in our labs and imaging protocols
Measured: 10 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start24 Apr 2019
- Primary completion24 Apr 2029 (estimated)
- Study completion30 Apr 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infective EndocarditisStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 1,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Queen Mary University of London
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Simon Woldman, MSc, Principal investigator, St Bartholomews Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06434012
- Sponsor's protocol ID
- 249740
- Status last verified
- Jul 2026
- First submitted
- 23 May 2024
- Last updated
- 17 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 17 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Barts Endocarditis Research Registry
- ClinicalTrials.gov ID
- NCT06434012
- Acronym / sponsor ID
- 249740
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,000 participants (estimated)
- Lead sponsor
- Queen Mary University of LondonUniversity, hospital or other
- Study start
- 24 Apr 2019 (actual)
- Primary completion
- 24 Apr 2029 (estimated)
- Study completion
- 30 Apr 2029 (estimated)
- First posted
- 30 May 2024 (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 Barts Endocarditis Research Registry is being set up to give a unique opportunity to assess the characteristics of Infective Endocarditis (IE) in our population cohort, the current use of imaging techniques, as well as the implementation of the ESC guidelines and its consequence in terms of prognosis. All this will help improve the diagnosis and management of IE. The registry will also form the core of all our subsequent work, including interventional studies. The endocarditis research registry is to record the epidemiological, demographic, microbiological, surgical and outcome data in our cohort of endocarditis patients. This work will underpin all future work in endocarditis by clearly defining our patient cohort and the outcomes from treatment. We have a series of studies planned that we believe will influence the management of endocarditis (we are working up proposals for genomic and therapeutic trials that will subsequently be presented for ethical and hospital approval). The registry will be generic to all our planned studies, and will allow us to capture data to assess treatment effectiveness
Detailed description
This research registry will give us the unique opportunity to assess the characteristics of IE in our population cohort, the current use of imaging techniques, as well as the implementation of the ESC guidelines and its consequence in terms of prognosis. All this will help improve the diagnosis and management of IE. The registry will also form the core of all our subsequent work, including interventional studies.
Infective endocarditis (IE) is a rare but serious disease, associated with high morbidity and in-hospital mortality. Despite improvements in diagnostic and therapeutic strategies the mortality remains at 15-30% in most published studies. The reasons for this persistent poor prognosis are numerous and include older patients with more severe disease, changes in the epidemiologic profiles and more patients with prosthetic or device related IE.
Following the formation of Barts Heart Centre (BHC) there was a sharp and noticeable increase in the number of patients with infective endocarditis (IE) referred to our centre. Recognising this change, the complexity of patients, and the coincident publication of the European Society of Cardiology Guidelines on Infective Endocarditis (2015), our Specialised Cardiology Directorate set up a new referral pathway, Standard Operating Procedure and Endocarditis Team meeting (MDT). The aim was to ensure focussed, consistent, and evidence-based care with joint medical and surgical input to this unique group of very unwell patients, with high inpatient mortality. In addition, the MDT would discuss and co-ordinate the care of all IE patients, with a weekly discussion of those on site, as well as at our referring hospitals. The MDT started in October 2015 and is composed of representatives from Cardiology (including imaging), Cardiac Surgery, Microbiology, Radiology/Nuclear Medicine and Pharmacy.
Since its inception, the MDT has discussed 367 patients at BHC and our wider referral centres (October 2015 - January 2018). Of those patients, 298 have been confirmed/probable as having IE: 144 surgically managed; 139 medically managed; 16 device extractions with intracardiac infection, all following international guidance. This does not include the grown-up congenital heart disease patients who are discussed and managed separately.
An audit database to track outcomes was started in January 2018, but there is a need to expand this work and make a registry that will form the foundation of all other research that we will undertake.
Mortality across the cohort has been at the lower end of international publications at 17.1% (51/298). Our current surgical mortality stands at 4.7% (14/298), which represents a significant reduction compared to pre-merger where combined mortality at the individual hospitals was 12.2%. In those patients who have died with medical management (37/51), the vast majority have had advanced life-limiting non-cardiac co-morbidities that preclude cardiac surgery (n=19) or on-going intravenous drug use after previous cardiac surgery for IE (n=6). Six patients have not been referred in time for surgery, having presented locally with septic shock and deteriorated rapidly, and this is an area of further education for our referring centres. Six patients have had operations without intra-operative evidence of infection. However, these patients had indications for surgery due to haemodynamically significant regurgitant valve disease.
Our morbidity and mortality reviews have allowed us to learn from all these cases, across all specialties and imaging modalities.
Not only has this approach led to improvements in patient care, but it has also raised the profile of BHC as a centre of special expertise. Our referring centres now include the DGH's of Barts Health NHS Trust (Whipps Cross University Hospital, Newham University Hospital, and The Royal London Hospital), plus many other district general hospitals in our locale.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 16 years and older
- Sex
- All
- Age groups
- Child, Adult, Older adult
- Study population
- There are approximately 150 cases of endocarditis each year treated within the trust and recruitment is expected to be rapid
Key inclusion criteria (6 listed)
- • Patients aged 16 and over (Patients under 16 years of age are not admitted to Barts Heart Centre)
Key exclusion criteria (3 listed)
- • Patients with pacemaker pocket infection with no evidence of pacemaker lead or valve infection
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 |
|---|---|---|
| registryThis is registry for Infective Endocarditis | Other | – |
Primary outcome
To define current mortality rates for patients treated for endocarditis at Barts Heart Centre
Time frame: 10 years
The primary goal of the endocarditis registry is to record the epidemiological, demographic, microbiological, surgical and outcome data in our cohort of endocarditis patients. This work will underpin all future work in endocarditis by clearly defining our patient cohort and the outcomes from treatment.
To define current morbidity rates for patients treated for endocarditis at Barts Heart Centre
Time frame: 10 years
The primary goal of the endocarditis registry is to record the epidemiological, demographic, microbiological, surgical and outcome data in our cohort of endocarditis patients. This work will underpin all future work in endocarditis by clearly defining our patient cohort and the outcomes from treatment.
To define current rates of reinfection for patients treated for endocarditis at Barts Heart Centre
Time frame: 10 years
The primary goal of the endocarditis registry is to record the epidemiological, demographic, microbiological, surgical and outcome data in our cohort of endocarditis patients. This work will underpin all future work in endocarditis by clearly defining our patient cohort and the outcomes from treatment.
To define current rates of relapse for patients treated for endocarditis at Barts Heart Centre
Time frame: 10 years
The primary goal of the endocarditis registry is to record the epidemiological, demographic, microbiological, surgical and outcome data in our cohort of endocarditis patients. This work will underpin all future work in endocarditis by clearly defining our patient cohort and the outcomes from treatment.
4 secondary outcomes
To collect data regarding infecting organism, valve appearances and pathological markers and investigate their relationship to mortality, morbidity, reinfection and relapse rates
Time frame: 10 years
To collect data regarding infecting organism and investigate its relationship to mortality, morbidity, reinfection and relapse rates
Time frame: 10 years
To collect data regarding valve appearance and investigate its relationship to mortality, morbidity, reinfection and relapse rates
Time frame: 10 years
To collect data regarding pathological markers and investigate its relationship to mortality, morbidity, reinfection and relapse rates
Time frame: 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 17 Jul 2026.
- Individual participant dataSharing planned: Undecided
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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.
Simon Woldman contact
Simon Woldman, MSc principal investigator
St Bartholomews Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Infective Endocarditis and Endocarditis, run by Queen Mary University of London at 1 site 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 6 inclusion and 3 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 17 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 1 site 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 Innocent Bvekerwa, MSc (07852209005, i.bvekerwa@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To define current mortality rates for patients treated for endocarditis at Barts Heart Centre (time frame: 10 years). The study lists 4 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 17 Jul 2026.