Involvement of the Gut Microbiota in Calcified Aortic Stenosis

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

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

100 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-01-01

Study Completion Date

2028-12-31

Brief Summary

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Calcific aortic stenosis (CAS) is a disease characterized by progressive calcification of the aortic valve, obstructing the passage of blood from the left ventricle into the general circulation. It is the most frequent cause of valve disease in the elderly. To date, no means of preventing the disease has been discovered, and the only treatment available is valve replacement during cardiac surgery, or percutaneous implantation of a valve prosthesis when the narrowing becomes severe and causes symptoms.

The intestinal flora or microbiota, the reservoir of all the microorganisms in the gut, is implicated in numerous diseases, particularly of the intestine. But to date, no study has established a link between CAS and microbiota. The intestinal microbiota acts through molecules produced by itself or the host and passing into the bloodstream. In the pathophysiology of CAS, the valve leaflets are breached and do not heal. These molecules can enter and have beneficial or deleterious effects, in particular promoting calcification of aortic valve cells.

Concrete objectives:

Improve understanding of calcific aortic stenosis in humans Study the composition of intestinal flora in patients with aortic stenosis and compare it with healthy subjects Study the molecules in the intestinal flora likely to be involved in the development of aortic stenosis in humans.

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Detailed Description

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Conditions

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Aortic Stenosis Gastrointestinal Microbiome Metabolomics

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Calcified Aortic Stenosis

Patients with calcified aortic valve or aortic stenosis will be enrolled Stool, blood samples and aortic valve of operated patients will be retrieved to evaluate the composition of the gut microbiota and its metabolites A follow up is planned for patients with no intervention on the aortic valve to assess the evolution of the aortic stenosis and the change in the gut microbiota.

No intervention

Intervention Type OTHER

No intervention

Control

Patients without calcified aortic valve will be enrolled Stool and blood samples will be retrieved to evaluate the composition of the gut microbiota and its metabolites No follow up is scheduled.

No intervention

Intervention Type OTHER

No intervention

Interventions

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No intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Group of patients with CAS:
* Calcified aortic stenosis diagnosed on a cardiac ultrasound or CT not older than 3 months
* Severe aortic stenosis: surgical indication based on symptoms and ultrasound data (high gradient aortic stenosis : Vmax\> 4m/s, mean gradient \> 40mmHg, area \< 1cm², low flow low-gradient CAS: left ventricular ejection fraction (LVEF) \< 40%, Vmax\< 4m/s, mean gradient \< 40mmHg, area \< 1cm², paradoxical low-gradient CAS: LVEF \> 55%, Vmax\< 4m/s, mean gradient \< 40mmHg, area \< 1cm²)
* Moderate CAS: 3m/s \<Vmax\< 4m/s, 20mmHg \< mean gradient \< 40mmHg
* Mild CAS: 2,6m/s \< Vmax \< 2.9m/s, mean gradient \< 20mmHg
* Aortic sclerosis: calcified remodeling of the aortic valve visible on ultrasound or CT.

Control group - free of CAS:

\- No calcified aortic stenosis verified on a cardiac ultrasound or CT not older than 3 months

Exclusion Criteria

* Treatment interfering with the composition of the intestinal microbiota: local or systemic corticosteroids within the last 3 months, antibiotics within the last 3 months, antiretrovirals, bile acid chelators (questran and colesevelam), HIV-targeted antiretroviral therapies, selective serotonin reuptake inhibitor-type antidepressants
* Clinical criteria: history of cholecystectomy, documented chronic liver disease in the patient, failure to fast on the day of the blood test, inflammatory bowel disease
* Patients requiring emergency intervention (myocardial infarction, acute aortic or mitral insufficiency, cardiogenic shock).
* AS of rheumatic origin, infective endocarditis.

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No