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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03979261
Other study ID # 2018-58
Secondary ID 2018-A02503-52
Status Not yet recruiting
Phase
First received
Last updated
Start date July 1, 2019
Est. completion date July 1, 2022

Study information

Verified date June 2019
Source Assistance Publique Hopitaux De Marseille
Contact Didier RAOULT, IP
Phone 04 13 73 20 5
Email didier.raoult@ap-hm.fr
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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.


Description:

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).


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 450
Est. completion date July 1, 2022
Est. primary completion date July 1, 2022
Accepts healthy volunteers
Gender All
Age group 18 Years and older
Eligibility 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

Study Design


Intervention

Diagnostic Test:
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.

Locations

Country Name City State
France Laboratoires d'immunologie et d'infectiologie Marseille Cedex 5

Sponsors (1)

Lead Sponsor Collaborator
Assistance Publique Hopitaux De Marseille

Country where clinical trial is conducted

France, 

Outcome

Type Measure Description Time frame Safety issue
Primary Evolution of sex ratio as a function of age and underlying pathologies (comorbidities and valvulopathies) 36 months
Secondary transcriptional profile by microarray rate of indigenous valves removed in patients with valvulopathy without endocarditis by gender 36 months
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