Brief Title
Myeloid Cells in Aortic Valve Stenosis
Official Title
Myeloid Cell Reprogramming in Aortic Valve Stenosis
Brief Summary
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
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.
Study Type
Observational
Primary Outcome
Inflammatory phenotype of circulating immune cells.
Condition
Aortic Valve Disease
Intervention
Blood drawing
Study Arms / Comparison Groups
Severe CAVD with atherosclerosis
Description: Participants with severe CAVD and significant atherosclerosis
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Other
Estimated Enrollment
400
Start Date
November 19, 2020
Completion Date
November 1, 2022
Primary Completion Date
November 1, 2022
Eligibility Criteria
Inclusion Criteria: - Age > 18 years - Moderate to 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: - Auto-inflammatory or auto-immune diseases - Use of anti-inflammatory drugs - Vaccination less than one month before inclusion - Bone marrow transplantation in medical history - Active hematological disease.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Contacts
Niels P. Riksen, prof. dr., +31-343618819, [email protected]
Location Countries
Netherlands
Location Countries
Netherlands
Administrative Informations
NCT ID
NCT04717219
Organization ID
NL72973.091.20
Responsible Party
Principal Investigator
Study Sponsor
Radboud University
Study Sponsor
Niels P. Riksen, prof. dr., Principal Investigator, Radboud University
Verification Date
January 2021