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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Severe CAVD with atherosclerosis | Participants with severe CAVD and significant atherosclerosis |
| |
| Severe CAVS without atherosclerosis | Participants with severe CAVD without significant atherosclerosis |
| |
| Moderate CAVD with atherosclerosis | Participants with mild or moderate CAVD and significant atherosclerosis |
| |
| Moderate CAVD without atherosclerosis | Participants with mild or moderate CAVD without significant atherosclerosis |
| |
| Healthy controls | 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). |
| |
| Controls with bicuspid aortic valve stenosis | Controls with bicuspid aortic valve stenosis, without a history of atherosclerotic cardiovascular events, current typical complaints of angina pectoris or intermittent claudication. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Blood drawing | Other | Blood will be drawn after inclusion of the participants. |
|
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
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Patients who present themselves or are already known at the department of cardiology or cardiothoracic surgery with the diagnosis of moderate or severe aortic valve stenosis as defined by transthoracic echocardiography according to the 2017 ESC/EACTS guidelines for the management of valvular heart disease.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Niels P. Riksen, prof. dr. | Contact | +31-343618819 | Niels.Riksen@radboudumc.nl |
| Name | Affiliation | Role |
|---|---|---|
| Niels P. Riksen, prof. dr. | Radboud University Medical Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rijnstate | Not yet recruiting | Arnhem | Netherlands |
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| ID | Term |
|---|---|
| D000082862 | Aortic Valve Disease |
| D001024 | Aortic Valve Stenosis |
| D006349 | Heart Valve Diseases |
| D007249 | Inflammation |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D014694 | Ventricular Outflow Obstruction |
| D010335 | Pathologic Processes |
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| ID | Term |
|---|---|
| D001800 | Blood Specimen Collection |
| ID | Term |
|---|---|
| D013048 | Specimen Handling |
| D019411 | Clinical Laboratory Techniques |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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|
| Radboud university medical center | Recruiting | Nijmegen | 6500 GA | Netherlands |
|
| Canisius Wilhelmina Ziekenhuis | Not yet recruiting | Nijmegen | Netherlands |
|
| D013568 | Pathological Conditions, Signs and Symptoms |
| D011677 | Punctures |
| D013514 | Surgical Procedures, Operative |
| D008919 | Investigative Techniques |