Inflammation and Infective Endocarditis

NCT06871215 | Withdrawn

• 1 other identifier: 19720646
• Study Type: observational
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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. 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 Based on unpublished pilot data (valve tissue) from a small cohort of patients (n=3), the investigators hypothesise that the immune system - which is usually responsible for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).

Conditions

Infective Endocarditis (IE)

Keywords

Endocarditis; Transcatheter; Valve; Congenital

Outcome Measures

Primary Outcomes (1)

• 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.

  18 months

Secondary Outcomes (1)

• Peripheral and valvular T-cell phenotype

  18 months

Study Arms (5)

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

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

A cohort of 100 patients with infective endocarditis who will be recruited from within Barts Health NHS Trust.

You may qualify if:

• A clinical diagnosis of infective endocarditis according to the Duke Criteria.

You may not qualify if:

• Active solid organ or haematological malignancy.

Sponsors & Collaborators

• Barts & The London NHS Trust: lead
• Queen Mary University of London: collaborator

Study Sites (1)

Barts Health NHS Trust

London, United Kingdom

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

Peripheral blood mononuclear cells and heart valve tissue.

MeSH Terms

Conditions

Endocarditis

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Study Officials

• Federica Marelli-Berg, MD PhD

  Queen Mary University of London

  STUDY DIRECTOR

• Simon Woldman, MD

  Barts & The London NHS Trust

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2025
• First Posted: March 11, 2025
• Study Start: August 1, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): October 1, 2026
• Last Updated: November 19, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)