Physical Training in Transposition of the Great Arteries

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

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00837603

Acronym

TrainingTGA

Enrollment

Registered

2009-02-05

Start date

2009-02-28

Completion date

2011-01-31

Last updated

2012-03-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Transposition of Great Vessels

Keywords

tga, atrial switch, training

Brief summary

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

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.

Interventions

BEHAVIORALTraining

Controlled home ergometer training

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

DIAGNOSTIC

Masking

SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender

ALL

Age

18 Years to 40 Years

Healthy volunteers

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)

Design outcomes

Primary

Measure	Time frame
Cardiac MRI Right Ventricular Ejection Fraction	6 and 12 months
Cardiopulmonary exercise capacity	6 and 12 months

Secondary

Measure	Time frame
Right ventricular volumes	6 and 12 months
Right ventricular mass	6 and 12 months
laboratory markers of heart failure	6 and 12 months
quality of life questionnaire	6 and 12 months
NYHA-class	6 and 12 months
Diastolic RV and LV function	6 and 12 months

Countries

Germany

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 22, 2026