Physical Training in Transposition of the Great Arteries

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Influence of Physical Training on Cardiopulmonary Exercise Capacity and Right Ventricular Function in Patients With D-TGA and Atrial Switch Operation.

Conditions
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Transposition of Great Vessels

Intervention / Treatment
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* Behavioral: Training


Participation Criteria
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Eligibility Criteria
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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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Training<br>Ergometer Training | Behavioral: Training<br>* Controlled home ergometer training<br>* Other names: physical exercise;|
| No Intervention: 2<br>Counseling | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cardiac MRI Right Ventricular Ejection Fraction |  | 6 and 12 months | 
| Cardiopulmonary exercise capacity |  | 6 and 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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tga, atrial switch, training