Physical Training in Transposition of the Great Arteries (TrainingTGA)
Influence of Physical Training on Cardiopulmonary Exercise Capacity and Right Ventricular Function in Patients With D-TGA and Atrial Switch Operation.
研究概览
详细说明
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.
研究类型
注册 (预期的)
阶段
- 不适用
联系人和位置
学习地点
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Hannover、德国、30623
- Hannover Medical School
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参与标准
资格标准
适合学习的年龄
接受健康志愿者
有资格学习的性别
描述
Inclusion Criteria:
- age >=18 years
Exclusion Criteria:
- tricuspid regurgitation grade 2 or more
- sign. LVOTO or RVOTO
- pacemaker or defibrillator
- recent hospitalisation for heart failure (90 days)
学习计划
研究是如何设计的？
设计细节
- 主要用途：诊断
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：单身的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
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有源比较器：Training
Ergometer Training
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Controlled home ergometer training
其他名称：
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无干预：2
Counseling
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研究衡量的是什么？
主要结果指标
结果测量 |
大体时间 |
|---|---|
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Cardiac MRI Right Ventricular Ejection Fraction
大体时间：6 and 12 months
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6 and 12 months
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Cardiopulmonary exercise capacity
大体时间：6 and 12 months
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6 and 12 months
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次要结果测量
结果测量 |
大体时间 |
|---|---|
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laboratory markers of heart failure
大体时间：6 and 12 months
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6 and 12 months
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Diastolic RV and LV function
大体时间：6 and 12 months
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6 and 12 months
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Right ventricular volumes
大体时间：6 and 12 months
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6 and 12 months
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Right ventricular mass
大体时间：6 and 12 months
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6 and 12 months
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NYHA-class
大体时间：6 and 12 months
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6 and 12 months
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quality of life questionnaire
大体时间：6 and 12 months
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6 and 12 months
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合作者和调查者
调查人员
- 首席研究员：Philip Roentgen, MD、Hannover Medical School
- 学习椅：Gerd P Meyer, MD、Hannover Medical School
出版物和有用的链接
一般刊物
- Westhoff-Bleck M, Schieffer B, Tegtbur U, Meyer GP, Hoy L, Schaefer A, Tallone EM, Tutarel O, Mertins R, Wilmink LM, Anker SD, Bauersachs J, Roentgen P. Aerobic training in adults after atrial switch procedure for transposition of the great arteries improves exercise capacity without impairing systemic right ventricular function. Int J Cardiol. 2013 Dec 5;170(1):24-9. doi: 10.1016/j.ijcard.2013.10.009. Epub 2013 Oct 11.
- Tutarel O, Rontgen P, Bode-Boger SM, Martens-Lobenhoffer J, Westhoff-Bleck M, Diller GP, Bauersachs J, Kielstein JT. Symmetrical dimethylarginine is superior to NT-proBNP for detecting systemic ventricular dysfunction in adults after atrial repair for transposition of the great arteries. Int J Cardiol. 2013 Oct 9;168(4):4415-6. doi: 10.1016/j.ijcard.2013.05.030. Epub 2013 May 24. No abstract available.
研究记录日期
研究主要日期
学习开始
初级完成 (实际的)
研究完成 (实际的)
研究注册日期
首次提交
首先提交符合 QC 标准的
首次发布 (估计)
研究记录更新
最后更新发布 (估计)
上次提交的符合 QC 标准的更新
最后验证
更多信息
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