Cardiac Remodeling and Circulating Biomarkers in Pediatric Left Ventricular Pressure Loading Lesions
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- Left ventricular mass
研究概览
简要总结
This study is designed to learn more about children who have blockage of the left side of their heart. The goal is to determine how much the heart muscle has thickened before surgery and how it changes in the months after surgery. Investigators are also looking for blood tests that may help them predict which patients will have the most thickening pre-operatively and the best return towards normal after surgery. The findings of this study will help the investigators develop new tests to monitor affected patients and develop new therapies to help minimize heart thickening.
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
- — 至 18 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Congenital heart disease patients with the following diagnoses undergoing surgical repair: Coarctation of the aorta (CoA), aortic stenosis (AS), subaortic membrane (sub-AS), supravalvar aortic stenosis (supra-AS).
- •All patients will have age from birth through 18 years of age.
- •While we will generally not enroll patients with other co-morbid heart disease that would alter the cardiac physiology (see exclusion criteria), patients with patent foramen ovale, atrial septal defect, and patent ductus arteriosus specifically will be allowed.
排除标准
- •Patients with lesions not listed in inclusion criteria (including but not limited to hypoplastic left heart syndrome, Shone's complex, mitral valve stenosis or regurgitation greater than trivial, non-restrictive ventricular septal defect, interrupted aortic arch, atrio-ventricular canal defect)
- •Corrected gestational age at time of surgery <34 weeks
- •Weight at time of surgery <2000g.
- •Patients who will not be seen for any follow-up care at Children's Hospital Colorado
结局指标
主要结局
Left ventricular mass
时间窗: 1 year after surgery
Left ventricular mass will be measured by 2D echocardiography at 1 year after surgical correction.
Change in left ventricular mass
时间窗: Within 1 week prior to surgery, 24-72 hrs after surgery, 1 year after surgery
Left ventricular mass will be measured by 2D echocardiography prior to surgery, immediately after surgery, and will be compared to that measured at 1 year after surgical correction.
次要结局
- Relative wall thickness(1 year after surgery)
- Left ventricular mass(1 year after surgery)
- Change in left ventricular mass(Within 1 week prior to surgery and 1 year after surgery)
- Change in relative wall thickness(24-72 hours and 1 year after surgery)