Predisposition to Infectious Endocarditis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Total Enrollment

450 participants

Study Classification

OBSERVATIONAL

Study Start Date

2019-07-01

Study Completion Date

2022-07-01

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

To evaluate the gender-related elements, a first step will be to analyze the impact of sex ratio on different parameters such as age in endocarditis and the type of underlying valvulopathy and other associated comorbidities.

Related Clinical Trials

Explore similar clinical trials based on study characteristics and research focus.

Infective Endocarditis in Developing Countries, a Prospective, Observational, Multicentre Study

NCT02128139

Infective Endocarditis

COMPLETED

Evolution of the Profile of Infectious Endocarditis in France in 2008 (EI2008)

NCT03295045

Infective Endocarditis

COMPLETED

Investigation of the Influence of Gender on Cardiovascular Function

NCT01582321

Cardiovascular Function

COMPLETED EARLY_PHASE1

Infective Endocarditis in the Elderly

NCT02910856

Infective Endocarditis

COMPLETED

Gender Difference in NET Activation in Patients With Congenital Heart Disease and Heart Failure

NCT05263843

Congenital Heart Disease Heart Failure Gender

UNKNOWN

Detailed Description

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Numerous epidemiological studies have made it possible to highlight the impact of the genus on the occurrence and natural evolution of numerous valvulopathies. Severe valve leakage occurs more frequently in men. This association is also observed in patients with aortic bicuspid infarction where infective endocarditis (IE) is 3 times more common in men with a sex ratio of 9 to 2 to 1. Male sex is also a risk factor of AEs in the admission score used in initial patient management used to stratify the risk of AE and start probabilistic antibiotic therapy. Several hypotheses were evoked and none made it possible to understand the impact of sex on the risk of IE. The transcriptome study of IE patients revealed 2 potential biomarkers. S100A11 (S100 calcium binding protein A11) is a diagnostic marker and AQP9 (Aquaporin 9 gene) a poor prognostic factor in patients with AE. Coxiella burnetii AE is more common and more severe in humans. A study in the C57 / BL6 mouse demonstrated the role of 17 beta-estradiol in decreasing bacterial load and granuloma formation in female mice. The hypothesis formulated is that sex hormones play a role in the natural history of IS. This hypothesis was confirmed at the transcriptome level in mice and allowed to identify transcriptomic signatures according to sex; male mice with a more marked inflammatory response to C. burnetii. In order to evaluate the gender-related elements, an initial work will be to analyze the impact of sex ratio on different parameters such as age in endocarditis and the type of underlying valvulopathy and other associated comorbidities.

The second part of the project will study (i) the transcriptional profile of the native valves removed in patients with endocarditis-free valvulopathy in male and female subjects (ii) the transcriptional profile of native valves removed during endocarditis in matching sex underlying valvulopathy and microorganism. This will evaluate a possible difference in susceptibility to endocardial fixation. (iii) the transcriptional profile of PBMCs (circulating mononuclear cells) in this same patient, which will make it possible to study the transcriptional profile of the circulating genes and to evaluate the possible difference in predisposition to endocardial fixation.

Finally, the third part will focus on the histological analysis of the valves collected to study the differences between man and woman (local inflammatory reaction, cell type found).

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Infective Endocarditis

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

sex ratio evaluation

Valvular surgery is performed in 30-40% of cases. The Cardiology and Cardiac Surgery De la Timone services 1000 patients as part of their valvulopathy and 450 benefit from cardiac surgery. On the other hand, transcriptomic analysis by microarray will only be done on 40 patients because the analysis costs 150 € / patients.

evolution of sex ratio according to age

Intervention Type DIAGNOSTIC_TEST

Histological study of the collected valves to study the differences according to the sex of the inflammatory reaction and the cellular type found.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

evolution of sex ratio according to age

Histological study of the collected valves to study the differences according to the sex of the inflammatory reaction and the cellular type found.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

* Patient with infectious endocarditis
* Patient with valvulopathy or infective endocarditis requiring cardiac surgery as part of routine care.
* Major patient
* Patient informed of the study and having expressed no opposition to participate in the study.
* Patient affiliated to a social security scheme.

Exclusion Criteria

* Minor patient
* Pregnant or nursing patient.
* Patient deprived of liberty or under judicial decision.
* Major patient under tutorship or curatorship.
* Patient not agreeing to participate

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No