Myeloid Cells in Aortic Valve Stenosis
- Conditions
- Aortic Valve DiseaseAortic Valve Stenosis
- Interventions
- Other: Blood drawing
- 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
- 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.
- 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
- Arm && Interventions
Group Intervention Description Moderate CAVD without atherosclerosis Blood drawing Participants with mild or moderate CAVD without significant atherosclerosis Controls with bicuspid aortic valve stenosis Blood drawing Controls with bicuspid aortic valve stenosis, without a history of atherosclerotic cardiovascular events, current typical complaints of angina pectoris or intermittent claudication. Severe CAVS without atherosclerosis Blood drawing Participants with severe CAVD without significant atherosclerosis Healthy controls Blood drawing 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). Severe CAVD with atherosclerosis Blood drawing Participants with severe CAVD and significant atherosclerosis Moderate CAVD with atherosclerosis Blood drawing Participants with mild or moderate CAVD and significant atherosclerosis
- Primary Outcome Measures
Name Time Method 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
Name Time Method
Trial Locations
- Locations (3)
Radboud university medical center
🇳🇱Nijmegen, Netherlands
Canisius Wilhelmina Ziekenhuis
🇳🇱Nijmegen, Netherlands
Rijnstate
🇳🇱Arnhem, Netherlands