Variability of Ventricular Mass, Volume, and Ejection Fraction in Pediatric Cardiomyopathy Patients (A Study Conducted by the Pediatric Heart Network)
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 131
- 试验地点
- 8
- 主要终点
- Inter-study variability of echo measurements; variance at a single point in time and variance of change in measurements over time
研究概览
简要总结
This observational study will provide data (variations in ventricular size and function) that are essential to designing and conducting clinical trials. In addition, the study will evaluate intra- and inter-study variability seen in echocardiography.
详细描述
BACKGROUND:
Cardiomyopathy is an important cause of chronic disability and death in pediatric patients and currently accounts for approximately 50% of cardiac transplants performed during childhood. Left ventricular (LV) size and function are important independent predictors of outcome, and echocardiography is the primary way to assess ventricular function in children. Although there is extensive experience with this technology, data are limited on how ventricular function changes over time in children, which is a major impediment to conducting controlled trials of therapy in children.
This study has been approved by the Institutional Review Boards/Research Ethics Boards of all participating clinical centers:
Hospital for Sick Children, Toronto, Canada
Children's Hospital Boston, Boston, MA
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
- — 至 22 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Less than 22 years of age
- •Diagnosis of dilated cardiomyopathy
- •LV and diastolic diameter greater than 5.5 cm (or z-score for BSA greater than 2) on the primary image acquisition from the first study echocardiogram
- •LV ejection fraction less than 50% (or z-score for age less than -2) or shortening fraction less than 28% (or z-score for age less than -2) as measured on the primary image acquisition from the first study echocardiogram
- •Disease onset greater than 2 months prior to screening
- •Anticipated to undergo repeat evaluation at the same institution at least 3 months but not more than 13 months later
- •Informed consent of parent(s) or legal guardian and assent of subject if required
排除标准
- •Hypertrophic cardiomyopathy
- •Restrictive cardiomyopathy
- •Myocardial noncompaction (LV hypertrabeculation); patient is eligible for the study as long as the echocardiogram performed at the time of screening has no evidence of myocardial noncompaction
- •Ventricular paced rhythm
- •Atrial or ventricular ectopy at ratio greater than 1:4
- •Suspected acute myocarditis
- •Tachycardia-induced cardiomyopathy
- •Congenital heart disease (repaired or unrepaired)
- •Currently on intravenous inotropic support
- •Current left ventricular assist device (LVAD) or extracorporeal membrane oxygenation (ECMO)
- •Heart transplant waiting list status of 1A or 1B
- •Co-morbid condition that precludes the ability to successfully obtain an echocardiogram according to the specifications of the study protocol
结局指标
主要结局
Inter-study variability of echo measurements; variance at a single point in time and variance of change in measurements over time
时间窗: Measured for up to 18 months
次要结局
- Relative magnitude of the various sources of variability in echocardiographic outcomes in order to optimize operational procedures that can minimize variance(Measured for up to 18 months)
- Interstudy variability of echocardiographically-derived indices of LV systolic and diastolic function derived from m-mode, spectral Doppler, and tissue Doppler techniques used in pediatric patients with dilated cardiomyopathy(Measured for up to 18 months)
- Relationship of clinical status, including treatment, to the interstudy variability and repeatability of echocardiographic measurements.(Measured for up to 18 months)