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Myeloid Cells in Aortic Valve Stenosis

Conditions
Aortic Valve Disease
Aortic Valve Stenosis
Registration Number
NCT04717219
Lead Sponsor
Radboud University Medical Center
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.

Recruitment & Eligibility

Status
UNKNOWN
Sex
All
Target Recruitment
400
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

Study & Design

Study Type
OBSERVATIONAL
Study Design
Not specified
Primary Outcome Measures
NameTimeMethod
Inflammatory phenotype of circulating immune cells.2 years

The inflammatory phenotype of circulating immune cells will be measured by determining the cytokine production capacity after stimulation with relevant stimuli.

Secondary Outcome Measures
NameTimeMethod

Trial Locations

Locations (3)

Rijnstate

🇳🇱

Arnhem, Netherlands

Radboud university medical center

🇳🇱

Nijmegen, Netherlands

Canisius Wilhelmina Ziekenhuis

🇳🇱

Nijmegen, Netherlands

Rijnstate
🇳🇱Arnhem, Netherlands
R. Pisters, MD, PhD
Contact

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