Study Results
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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UNKNOWN
400 participants
OBSERVATIONAL
2020-11-19
2022-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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CASE_CONTROL
PROSPECTIVE
Study Groups
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Severe CAVD with atherosclerosis
Participants with severe CAVD and significant atherosclerosis
Blood drawing
Blood will be drawn after inclusion of the participants.
Severe CAVS without atherosclerosis
Participants with severe CAVD without significant atherosclerosis
Blood drawing
Blood will be drawn after inclusion of the participants.
Moderate CAVD with atherosclerosis
Participants with mild or moderate CAVD and significant atherosclerosis
Blood drawing
Blood will be drawn after inclusion of the participants.
Moderate CAVD without atherosclerosis
Participants with mild or moderate CAVD without significant atherosclerosis
Blood drawing
Blood will be drawn after inclusion of the participants.
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).
Blood drawing
Blood will be drawn after inclusion of the participants.
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.
Blood drawing
Blood will be drawn after inclusion of the participants.
Interventions
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Blood drawing
Blood will be drawn after inclusion of the participants.
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
ALL
Yes
Sponsors
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Radboud University Medical Center
OTHER
Responsible Party
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Niels Riksen
Prof. dr.
Principal Investigators
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Niels P. Riksen, prof. dr.
Role: PRINCIPAL_INVESTIGATOR
Radboud University Medical Center
Locations
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Rijnstate
Arnhem, , Netherlands
Radboud university medical center
Nijmegen, , Netherlands
Canisius Wilhelmina Ziekenhuis
Nijmegen, , Netherlands
Countries
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Central Contacts
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Facility Contacts
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R. Pisters, MD, PhD
Role: primary
E.S. Zegers, MD
Role: primary
Other Identifiers
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NL72973.091.20
Identifier Type: -
Identifier Source: org_study_id
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