Myeloid Cell Reprogramming in Aortic Valve Stenosis
试验速览
- 阶段
- 不适用
- 入组人数
- 400
- 试验地点
- 3
- 主要终点
- Inflammatory phenotype of circulating immune cells.
研究概览
简要总结
Investigators plan to characterize systemic inflammation and circulating immune cells in participants with moderate and severe calcific aortic valve disease and matched healthy controls.
详细描述
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.
研究设计
- 研究类型
- Observational
- 观察模型
- Case Control
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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
结局指标
主要结局
Inflammatory phenotype of circulating immune cells.
时间窗: 2 years
The inflammatory phenotype of circulating immune cells will be measured by determining the cytokine production capacity after stimulation with relevant stimuli.
次要结局
未报告次要终点
研究者
Niels Riksen
Prof. dr.
Radboud University Medical Center