Infective Endocarditis (IE)NCT06871215
Inflammation and Infective Endocarditis
An observational study of Infective Endocarditis (IE), run by Barts & The London NHS Trust at 1 site in United Kingdom.
Trial summary
Infective endocarditis (IE) is caused by bloodstream bacteria becoming adherent to, and eventually destroying, heart valve tissue. It is a condition that is becoming increasingly common and is associated with significant morbidity and mortality. Read more about this study
- Who is it for?
- Ages 18 to 85 years
- Conditions the study is for
- Infective Endocarditis (IE)
- How many people
- 0 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 1 Aug 2025to 1 Oct 2026
- Phase
- Observational
- Are there results?
- None posted in the registry
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 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: A cohort of 100 patients with infective endocarditis who will be recruited from within Barts Health NHS Trust.
Who may be able to join
- A clinical diagnosis of infective endocarditis according to the Duke Criteria.
Who cannot join
- Active solid organ or haematological malignancy.
Trial locations and contacts
1 site in 1 country.
About this study
Infective endocarditis (IE) is caused by bloodstream bacteria becoming adherent to, and eventually destroying, heart valve tissue. It is a condition that is becoming increasingly common and is associated with significant morbidity and mortality. IE is more common in patients with previous valve replacements and those with congenital heart disease (both corrected and uncorrected). Current treatments in IE are extremely limited; patients are typically managed with intravenous antibiotics and high risk cardiac surgery. Based on unpublished pilot data (valve tissue) from a small cohort of patients (n=3), the investigators hypothesise that the immune system - which is usually responsible for fighting infections - in IE is overactive and may in fact play a role in disease progression. It is possible that adaptive immune cells (B- and T- lymphocytes) that have been exposed to cardiac proteins as a result of bacterial damage, may attack the heart and exacerbate valve destruction. The investigators hypothesise that through the analysis of adaptive immune cells in the blood and valve tissue, it will be possible to identify patients with IE who may have a form of autoimmune heart disease, who might stand to benefit from innovative immune-modulating therapies. To address this hypothesis, the investigators will undertake the following: 1. An observational cohort study in patients with IE to analyse the immune cell status in the peripheral blood and valve tissue (obtained at surgical explant).
Read the detailed description
Infective endocarditis (IE) is challenging to diagnose despite modern, multi-modality imaging techniques. Its frequency is increasing as more interventions are performed on patients with pre-existing valve disease. Current strategies for diagnosis and management are relatively historical; patients require positive blood cultures and are managed with intravenous antibiotics and cardiac surgery. While the immunological complications of IE are well recognised (e.g. rheumatoid factor positivity), there has been very little research to explore the immune system's role in disease onset and progression. The investigators laboratory has discovered and characterised a group of circulating immune cells (cMET+ T-cells) that appear to have a direct role in the progression of another inflammatory heart disease known as myocarditis. Pilot data from the investigators laboratory (n=3 patients) suggests that these cells are also detectable in explanted valve tissue from patients undergoing endocarditis surgery. The investigators suspect that the presence of these cells in IE implies that there may be a significant contribution to disease progression from the immune system. It is possible that the exposure of cardiac proteins by damage caused by a bacterial infection primes the immune system against self, and that these auto-reactive T-cells then go on to attack and destroy native valve tissue. The investigators would like to investigate whether circulating and myocardial cMET+ T-cells are detectable across the wide spectrum of patients with IE and further explore their role in this condition. The investigators are planning to functionally characterise both circulating cells and those that are detectable in explanted valve tissue using a combination of flow cytometry and spatial RNA sequencing. The investigators propose that cMET+ T-cells may have utility in the diagnosis of IE and that in patients with a significantly elevated number, the investigators might be able to offer novel (and highly specific) targeted immunological therapy that could improve patient outcomes.
- Conditions
- Infective Endocarditis (IE)
- Keywords
- Endocarditis, Transcatheter, Valve, Congenital
- Medical subject headings
- Endocarditis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Native valve | Patients with IE that affects their native heart valve(s). | |
| Prosthetic valve | Patients with IE that affects an artificial heart valve. | |
| Cardiac-device related | Patients with IE associated with a cardiac device (e.g. pacemaker). | |
| Uncorrected congenital | Patients with IE associated with uncorrected congenital heart disease. | |
| Recurrent | Patients with IE where it is not their first episode |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peripheral and valvular cMET+ T-cell frequency
The proportion of T-cells in the peripheral blood and myocardial valve tissue that express the receptor cMET, which has been described as a marker of cardiac autoimmunity will be assessed by flow cytometry.
Measured: 18 months
Secondary outcomes (1)
Peripheral and valvular T-cell phenotype
Pre-defined T-cell flow cytometry panels will be used to interrogate the expression of various surface and intracellular markers (activation, memory status, cytokine expression) on peripheral and valvular T-cells.
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Mar 2025
- Study start1 Aug 2025 (estimated)
- Primary completion1 Oct 2026 (estimated)
- Study completion1 Oct 2026 (estimated)
Why it stopped: Submission has now been withdrawn
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Infective Endocarditis (IE)Studies 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
- Prospective
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Barts & The London NHS Trust
- Sponsor type
- University, hospital or other
- Collaborators
- Queen Mary University of London
- Responsible party
- Sponsor
- Investigators
- Federica Marelli-Berg, MD PhD, Study director, Queen Mary University of LondonSimon Woldman, MD, Study director, Barts & The London NHS Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06871215
- Sponsor's protocol ID
- 19720646
- Status last verified
- Nov 2025
- First submitted
- 27 Jan 2025
- Last updated
- 19 Nov 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 19 Nov 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Inflammation and Infective Endocarditis
- ClinicalTrials.gov ID
- NCT06871215
- Acronym / sponsor ID
- 19720646
- Conditions
- Infective Endocarditis (IE)
- Keywords
- Endocarditis, Transcatheter, Valve, Congenital
- Study type
- Observational
- Recruitment status
- WithdrawnReason stopped: Submission has now been withdrawn
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Barts & The London NHS TrustUniversity, hospital or other
- Collaborators
- Queen Mary University of London
- Study start
- 1 Aug 2025 (estimated)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 1 Oct 2026 (estimated)
- First posted
- 11 Mar 2025 (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.
Infective endocarditis (IE) is caused by bloodstream bacteria becoming adherent to, and eventually destroying, heart valve tissue. It is a condition that is becoming increasingly common and is associated with significant morbidity and mortality. IE is more common in patients with previous valve replacements and those with congenital heart disease (both corrected and uncorrected). Current treatments in IE are extremely limited; patients are typically managed with intravenous antibiotics and high risk cardiac surgery. Based on unpublished pilot data (valve tissue) from a small cohort of patients (n=3), the investigators hypothesise that the immune system - which is usually responsible for fighting infections - in IE is overactive and may in fact play a role in disease progression. It is possible that adaptive immune cells (B- and T- lymphocytes) that have been exposed to cardiac proteins as a result of bacterial damage, may attack the heart and exacerbate valve destruction. The investigators hypothesise that through the analysis of adaptive immune cells in the blood and valve tissue, it will be possible to identify patients with IE who may have a form of autoimmune heart disease, who might stand to benefit from innovative immune-modulating therapies. To address this hypothesis, the investigators will undertake the following: 1. An observational cohort study in patients with IE to analyse the immune cell status in the peripheral blood and valve tissue (obtained at surgical explant).
Detailed description
Infective endocarditis (IE) is challenging to diagnose despite modern, multi-modality imaging techniques. Its frequency is increasing as more interventions are performed on patients with pre-existing valve disease. Current strategies for diagnosis and management are relatively historical; patients require positive blood cultures and are managed with intravenous antibiotics and cardiac surgery. While the immunological complications of IE are well recognised (e.g. rheumatoid factor positivity), there has been very little research to explore the immune system's role in disease onset and progression. The investigators laboratory has discovered and characterised a group of circulating immune cells (cMET+ T-cells) that appear to have a direct role in the progression of another inflammatory heart disease known as myocarditis. Pilot data from the investigators laboratory (n=3 patients) suggests that these cells are also detectable in explanted valve tissue from patients undergoing endocarditis surgery. The investigators suspect that the presence of these cells in IE implies that there may be a significant contribution to disease progression from the immune system. It is possible that the exposure of cardiac proteins by damage caused by a bacterial infection primes the immune system against self, and that these auto-reactive T-cells then go on to attack and destroy native valve tissue. The investigators would like to investigate whether circulating and myocardial cMET+ T-cells are detectable across the wide spectrum of patients with IE and further explore their role in this condition. The investigators are planning to functionally characterise both circulating cells and those that are detectable in explanted valve tissue using a combination of flow cytometry and spatial RNA sequencing. The investigators propose that cMET+ T-cells may have utility in the diagnosis of IE and that in patients with a significantly elevated number, the investigators might be able to offer novel (and highly specific) targeted immunological therapy that could improve patient outcomes.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Native valve | – | –Patients with IE that affects their native heart valve(s). |
| Prosthetic valve | – | –Patients with IE that affects an artificial heart valve. |
| Cardiac-device related | – | –Patients with IE associated with a cardiac device (e.g. pacemaker). |
| Uncorrected congenital | – | –Patients with IE associated with uncorrected congenital heart disease. |
| Recurrent | – | –Patients with IE where it is not their first episode |
Who may qualify
- Ages
- 18 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- A cohort of 100 patients with infective endocarditis who will be recruited from within Barts Health NHS Trust.
Key inclusion criteria (1 listed)
- A clinical diagnosis of infective endocarditis according to the Duke Criteria.
Key exclusion criteria (1 listed)
- Active solid organ or haematological malignancy.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Peripheral and valvular cMET+ T-cell frequency
Time frame: 18 months
The proportion of T-cells in the peripheral blood and myocardial valve tissue that express the receptor cMET, which has been described as a marker of cardiac autoimmunity will be assessed by flow cytometry.
1 secondary outcome
Peripheral and valvular T-cell phenotype
Time frame: 18 months
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Nov 2025.
- Individual participant dataSharing planned: No
Related trials for Infective Endocarditis (IE)
Recruiting
From Commensalism to Pathogenicity: Exploring the Pathophysiology of Bacteremia to Better Understand Enterococcus Faecalis Infective Endocarditis
Infective Endocarditis (IE)
Active, not recruitingObservational study
Infective Endocarditis Surgery Using Conventional Prosthetic Valves Versus Cryopreserved Aortic Homograft
Infective Endocarditis, Heart Failure
Active, not recruitingObservational study
Long Term Management and Outcomes of Surgical and Non Surgical Infective Endocarditis
Infective Endocarditis (IE)
Recruiting
Reducing Risk for Infective Endocarditis
Bacteremia, Infective Endocarditis
RecruitingPhase 4
Anemia Therapy in Patients With Infective Endocarditis
Infective Endocarditis (IE), Severe Anemia
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. This study is not recruiting at the moment.
Federica Marelli-Berg, MD PhD study director
Queen Mary University of London
Simon Woldman, MD study director
Barts & The London NHS Trust
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 (IE), run by Barts & The London NHS Trust 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 1 inclusion and 1 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: withdrawn, as of the sponsor's last update on 19 Nov 2025. 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?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peripheral and valvular cMET+ T-cell frequency (time frame: 18 months). 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 19 Nov 2025.