NCT02588989进行中（未招募）不适用
Fibrosis, Valvular and Ventricular Function in Patients With Transposition of the Great Arteries
适应症
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 37
- 试验地点
- 1
- 主要终点
- Event-free survival
研究概览
简要总结
The aim of this project is to better evaluate the systemic right ventricular (RV) function in patients with transposition of the great arteries (TGA).
详细描述
Patients with TGA frequently develop supraventricular and ventricular arrhythmia, conduction problems, systemic atrioventricular valve (SAVV) regurgitation, and congestive heart failure (CHF), all at young age. However, there is variation in time of onset of these adverse events. We want to evaluate ventricular and valvular function at rest, markers of RV fibrosis and cardiac reserve.
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
- 16 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients with a TGA
- •Informed consent to participate. If the patient is under the age of 18, the assent of the patient and the permission of the parents to participate
排除标准
- •Previous double-switch intervention
- •Any medical contra-indication for cardiovascular magnetic resonance (CMR) imaging (e.g. pacemaker)
- •The presence of exercise-induced arrhythmia, symptomatic myocardial ischemia, a resting systolic blood pressure > 200 mm Hg and/or diastolic blood pressure > 110 mm Hg, New York Heart Association (NYHA) class III or IV, or non-cardiac co-morbidity that could aggravate by exercise
- •Additional exclusion criterion for delayed gadolinium enhancement CMR: any medical contra-indication for intravenous gadolinium
结局指标
主要结局
Event-free survival
时间窗: 10 years
Composite clinical end point
次要结局
未报告次要终点
研究者
研究点 (1)
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