Influence of Physical Training on Cardiopulmonary Exercise Capacity and Right Ventricular Function in Patients With D-TGA and Atrial Switch Operation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Cardiac MRI Right Ventricular Ejection Fraction
研究概览
简要总结
In transposition patients after atrial switch operation, the morphological right ventricle serves as the systemic ventricle. These patients often develop signs of heart failure. It is not known, whether physical training can safely be recommended in these patients- like heart failure guidelines recommend training in patients with normal anatomy. Furthermore it is not known, whether these TGA-patients benefit from training with respect to cardiopulmonary exercise capacity.
详细描述
This is a randomized, controlled, prospective trial on the safety of physical training in TGA patients after atrial switch operation.
In transposition patients after atrial switch operation, the morphological right ventricle serves as the systemic ventricle. These patients often develop signs of heart failure. It is not known, whether physical training can safely be recommended in these patients- like heart failure guidelines recommend training in patients with normal anatomy. Furthermore it is not known, whether these TGA-patients benefit from training with respect to cardiopulmonary exercise capacity.
Primary endpoints are Systemic Ventricle Ejection Fraction and Volumes, Exercise Capacity.
Secondary endpoints are Echo Diastolic Function, as well as laboratory markers of heart failure.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Diagnostic
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •age >=18 years
排除标准
- •tricuspid regurgitation grade 2 or more
- •sign. LVOTO or RVOTO
- •pacemaker or defibrillator
- •recent hospitalisation for heart failure (90 days)
结局指标
主要结局
Cardiac MRI Right Ventricular Ejection Fraction
时间窗: 6 and 12 months
Cardiopulmonary exercise capacity
时间窗: 6 and 12 months
次要结局
- laboratory markers of heart failure(6 and 12 months)
- Diastolic RV and LV function(6 and 12 months)
- Right ventricular volumes(6 and 12 months)
- Right ventricular mass(6 and 12 months)
- NYHA-class(6 and 12 months)
- quality of life questionnaire(6 and 12 months)