## Protocol Section
### Identification Module
**NCT ID:** NCT06434012

**Brief Title:** Barts Endocarditis Research Registry

**Official Title:** Barts Endocarditis Research Registry

#### Organization Study ID Info
**ID:** 249740
#### Organization
**Class:** OTHER
**Full Name:** Queen Mary University of London
### Status Module
#### Completion Date
**Date:** 2029-04-30

**Type:** ESTIMATED

#### Expanded Access Info
#### Last Update Post Date
**Date:** 2024-05-30

**Type:** ACTUAL

**Last Update Submit Date:** 2024-05-23

**Overall Status:** ACTIVE_NOT_RECRUITING

#### Primary Completion Date
**Date:** 2029-04-24

**Type:** ESTIMATED

#### Start Date
**Date:** 2019-04-24

**Type:** ACTUAL

**Status Verified Date:** 2024-05

#### Study First Post Date
**Date:** 2024-05-30
**Type:** ACTUAL
**Study First Submit Date:** 2024-05-23
**Study First Submit QC Date:** 2024-05-23
### Sponsor Collaborators Module

#### Lead Sponsor

**Class:** OTHER

**Name:** Queen Mary University of London

#### Responsible Party

**Investigator Affiliation:** Queen Mary University of London

**Investigator Full Name:** Innocent Bvekerwa

**Investigator Title:** Mr

**Type:** PRINCIPAL_INVESTIGATOR

### Oversight Module

**Is FDA Regulated Device:** False

**Is FDA Regulated Drug:** False

**Oversight Has DMC:** True

### Description Module

**Brief 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. 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.

### Conditions Module

**Conditions:**

- Infective Endocarditis

- Endocarditis

- Endocarditis, Bacterial

### Design Module

#### Design Info

**Observational Model:** COHORT

**Time Perspective:** RETROSPECTIVE

#### Enrollment Info

**Count:** 1000

**Type:** ESTIMATED

**Study Type:** OBSERVATIONAL

### Arms Interventions Module

### Interventions

#### Intervention 1

**Description:** This is registry for Infective Endocarditis

**Name:** registry

**Type:** OTHER

### Outcomes Module

#### Primary Outcomes

**Description:** 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.

**Measure:** To define current mortality, morbidity, reinfection and relapse rates for patients treated at Barts Heart Centre

**Time Frame:** 10 years

#### Secondary Outcomes

**Description:** 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

**Measure:** 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

### Eligibility Module

**Eligibility Criteria:** Inclusion Criteria:

* • 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

Exclusion Criteria:

* • 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

**Minimum Age:** 16 Years

**Sampling Method:** NON_PROBABILITY_SAMPLE

**Sex:** ALL

**Standard Ages:**

- 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

### Contacts Locations Module

#### Locations

**Location 1:**

**City:** London

**Country:** United Kingdom

**Facility:** St Bartholomews Hospital

#### Overall Officials

**Official 1:**

**Affiliation:** St Bartholomews Hospital

**Name:** Simon Woldman, MSc

**Role:** PRINCIPAL_INVESTIGATOR

### IPD Sharing Statement Module

**IPD Sharing:** UNDECIDED

## Derived Section

### Condition Browse Module - Ancestors

- ID: D000006331

- Term: Heart Diseases

- ID: D000002318

- Term: Cardiovascular Diseases

- ID: D000001424

- Term: Bacterial Infections

- ID: D000001423

- Term: Bacterial Infections and Mycoses

- ID: D000007239

- Term: Infections

- ID: D000053821

- Term: Cardiovascular Infections

### Condition Browse Module - Browse Branches

- Abbrev: BC01

- Name: Infections

- Abbrev: BC14

- Name: Heart and Blood Diseases

- Abbrev: All

- Name: All Conditions

- Abbrev: BC23

- Name: Symptoms and General Pathology

- Abbrev: Rare

- Name: Rare Diseases

### Condition Browse Module - Browse Leaves

- ID: M7859

- Name: Endocarditis, Bacterial

- Relevance: HIGH

- As Found: Endocarditis, Bacterial

- ID: M7858

- Name: Endocarditis

- Relevance: HIGH

- As Found: Endocarditis

- ID: M9419

- Name: Heart Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M10283

- Name: Infections

- Relevance: LOW

- As Found: Unknown

- ID: M6368

- Name: Communicable Diseases

- Relevance: LOW

- As Found: Unknown

- ID: M4722

- Name: Bacterial Infections

- Relevance: LOW

- As Found: Unknown

- ID: M12136

- Name: Mycoses

- Relevance: LOW

- As Found: Unknown

- ID: M4721

- Name: Bacterial Infections and Mycoses

- Relevance: LOW

- As Found: Unknown

- ID: M27489

- Name: Cardiovascular Infections

- Relevance: LOW

- As Found: Unknown

- ID: T3065

- Name: Infective Endocarditis

- Relevance: HIGH

- As Found: Infective Endocarditis

### Condition Browse Module - Meshes

- ID: D000004697

- Term: Endocarditis, Bacterial

- ID: D000004696

- Term: Endocarditis

### Misc Info Module

- Version Holder: 2024-05-31
