Physical Training in Transposition of the Great Arteries (TrainingTGA)
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00837603|
Recruitment Status : Completed
First Posted : February 5, 2009
Last Update Posted : March 9, 2012
|Condition or disease||Intervention/treatment||Phase|
|Transposition of Great Vessels||Behavioral: Training||Not Applicable|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||48 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Single (Outcomes Assessor)|
|Official Title:||Influence of Physical Training on Cardiopulmonary Exercise Capacity and Right Ventricular Function in Patients With D-TGA and Atrial Switch Operation.|
|Study Start Date :||February 2009|
|Actual Primary Completion Date :||September 2010|
|Actual Study Completion Date :||January 2011|
Active Comparator: Training
Controlled home ergometer training
No Intervention: 2
- 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 ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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|