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Physical Training in Transposition of the Great Arteries (TrainingTGA)

This study has been completed.
Sponsor:
Information provided by:
Hannover Medical School
ClinicalTrials.gov Identifier:
NCT00837603
First received: February 4, 2009
Last updated: March 8, 2012
Last verified: July 2011
History of Changes

February 4, 2009
March 8, 2012
February 2009
September 2010   (final data collection date for primary outcome measure)
  • Cardiac MRI Right Ventricular Ejection Fraction [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]
  • Cardiopulmonary exercise capacity [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]
Same as current
Complete list of historical versions of study NCT00837603 on ClinicalTrials.gov Archive Site
  • laboratory markers of heart failure [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]
  • Diastolic RV and LV function [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]
  • Right ventricular volumes [ Time Frame: 6 and 12 months ] [ Designated as safety issue: Yes ]
  • Right ventricular mass [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • NYHA-class [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
  • quality of life questionnaire [ Time Frame: 6 and 12 months ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
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.

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.

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.
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Transposition of Great Vessels
Behavioral: Training
Controlled home ergometer training
Other Names:
  • ergometer
  • physical exercise
  • Active Comparator: Training
    Ergometer Training
    Intervention: Behavioral: Training
  • No Intervention: 2
    Counseling
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
48
January 2011
September 2010   (final data collection date for primary outcome measure)

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)
Both
18 Years to 40 Years
No
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00837603
TGA2009
Yes
Helmut Drexler, MD, Professor of Medicine, Hannover Medical School
Hannover Medical School
Not Provided
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
Hannover Medical School
July 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP