Myeloid Cells in Aortic Valve Stenosis

Study Overview
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Brief Summary
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Investigators plan to characterize systemic inflammation and circulating immune cells in participants with moderate and severe calcific aortic valve disease and matched healthy controls.

Detailed Description
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Calcific aortic valve disease (CAVD) is the most common type of valvular heart disease in the Western world. Due to the aging of the population, the impact of this disorder is expected to further increase in the next decades. The underlying pathophysiology remains incompletely defined and there are currently no effective medical treatments capable of altering its course, identifying a major unmet need in this growing population of patients. Based on the similarities between CAVD and atherosclerosis in pathophysiology and shared risk factors, it is now hypothesized that activation of the innate immune system contributes to the development of CAVD. Therefore, the investigators will perform an observational study to assess the role of activation of the innate immune system in CAVD.

Official Title
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Myeloid Cell Reprogramming in Aortic Valve Stenosis

Conditions
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Aortic Valve Disease, Aortic Valve Stenosis

Intervention / Treatment
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* Other: Blood drawing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age > 18 years Mild, moderate or severe degenerative aortic valve stenosis as defined by transthoracic echocardiography according to the 2017 ESC/EACTS guidelines for the management of valvular heart disease. Exclusion Criteria: Active auto-inflammatory or auto-immune diseases Anti-inflammatory drugs Vaccination less than one month before inclusion Bone marrow transplantation Active malignancy, except for local basal cell carcinoma or local squamous cell skin carcinoma, that can be treated curatively by excision. History of endocarditis of the aortic valve History of radiation therapy aimed at the chest Acute ischemic cardiac event less than three months before inclusion Systemic inflammation less than one month before inclusion with fever and/or for which antibiotics have been prescribed, with the exception for the use of nitrofurantoin for a urinary tract infection without fever

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Severe CAVD with atherosclerosis<br>Participants with severe CAVD and significant atherosclerosis | Other: Blood drawing<br>* Blood will be drawn after inclusion of the participants.<br>|
| Severe CAVS without atherosclerosis<br>Participants with severe CAVD without significant atherosclerosis | Other: Blood drawing<br>* Blood will be drawn after inclusion of the participants.<br>|
| Moderate CAVD with atherosclerosis<br>Participants with mild or moderate CAVD and significant atherosclerosis | Other: Blood drawing<br>* Blood will be drawn after inclusion of the participants.<br>|
| Moderate CAVD without atherosclerosis<br>Participants with mild or moderate CAVD without significant atherosclerosis | Other: Blood drawing<br>* Blood will be drawn after inclusion of the participants.<br>|
| Healthy controls<br>Healthy controls without CAVD and without a history of atherosclerotic cardiovascular events, current typical complaints of angina pectoris or intermittent claudication and overt heart failure (NYHA class III/IV). | Other: Blood drawing<br>* Blood will be drawn after inclusion of the participants.<br>|
| Controls with bicuspid aortic valve stenosis<br>Controls with bicuspid aortic valve stenosis, without a history of atherosclerotic cardiovascular events, current typical complaints of angina pectoris or intermittent claudication. | Other: Blood drawing<br>* Blood will be drawn after inclusion of the participants.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Inflammatory phenotype of circulating immune cells. | The inflammatory phenotype of circulating immune cells will be measured by determining the cytokine production capacity after stimulation with relevant stimuli. | 2 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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calcific aortic valve disease, valvular heart disease, inflammation, innate immune cells