Myocardial Dysfunction in Pediatric Lupus
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- echocardiographic measurements
研究概览
简要总结
To investigate biomarkers to identify pediatric SR-SLE patients by non-invasive echocardiographic techniques.
详细描述
Systemic lupus erythematosus (SLE) is a heterogeneous autoimmune disease. Although therapeutic advances have improved outcomes, a significant subset remains with severe disease activity despite optimal therapy, which is recognized as the severe refractory SLE (SR-SLE).A recent study using advanced echocardiographic techniques of global longitudinal strain (GLS) have revealed that left ventricular dysfunction is common in SLE patients and correlates with disease severity.The finding underscores the potential role of early myocardial dysfunction as a phenotypic marker of SR-SLE.To our knowledge, there are no validated biomarkers to reliably identify patients with SR-SLE at an early stage, especially in the pediatric population. Therefore, this study aimed to investigate biomarkers to identify pediatric SR-SLE patients.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 7 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •fulfill the American College of Rheumatology (ACR) criteria
- •disease onset at ages before 18 years
排除标准
- •patients with a history of concomitant malignancy
- •patients with active bacterial, viral, fungal, mycobacterial infection
研究组 & 干预措施
children with SLE
Pediatric patients fulfilled the American College of Rheumatology (ACR) criteria with disease onset at ages before 18 years。
结局指标
主要结局
echocardiographic measurements
时间窗: 6 months
echocardiographic measurements including chamber dimensions, LV systolic and diastolic function, valve disease, strain values and etc..
次要结局
未报告次要终点
研究者
Shengfang Bao
Principal Investigator
Shanghai Jiao Tong University School of Medicine