Trials / Completed
CompletedNCT00837603
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
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 48 (estimated)
- Sponsor
- Hannover Medical School · Academic / Other
- Sex
- All
- Age
- 18 Years – 40 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BEHAVIORAL | Training | Controlled home ergometer training |
Timeline
- Start date
- 2009-02-01
- Primary completion
- 2010-09-01
- Completion
- 2011-01-01
- First posted
- 2009-02-05
- Last updated
- 2012-03-09
Locations
1 site across 1 country: Germany
Source: ClinicalTrials.gov record NCT00837603. Inclusion in this directory is not an endorsement.