Physical Training in Transposition of the Great Arteries (TrainingTGA)
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
|Official Title:||Influence of Physical Training on Cardiopulmonary Exercise Capacity and Right Ventricular Function in Patients With D-TGA and Atrial Switch Operation.|
- Cardiac MRI Right Ventricular Ejection Fraction [ Time Frame: 6 and 12 months ]
- Cardiopulmonary exercise capacity [ Time Frame: 6 and 12 months ]
- laboratory markers of heart failure [ Time Frame: 6 and 12 months ]
- Diastolic RV and LV function [ Time Frame: 6 and 12 months ]
- Right ventricular volumes [ Time Frame: 6 and 12 months ]
- Right ventricular mass [ Time Frame: 6 and 12 months ]
- NYHA-class [ Time Frame: 6 and 12 months ]
- quality of life questionnaire [ Time Frame: 6 and 12 months ]
|Study Start Date:||February 2009|
|Study Completion Date:||January 2011|
|Primary Completion Date:||September 2010 (Final data collection date for primary outcome measure)|
Active Comparator: Training
Controlled home ergometer training
No Intervention: 2
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00837603
|Hannover Medical School|
|Hannover, Germany, 30623|
|Principal Investigator:||Philip Roentgen, MD||Hannover Medical School|
|Study Chair:||Gerd P Meyer, MD||Hannover Medical School|
|Study Director:||Helmut Drexler, MD||Hannover Medical School|