Clinical trial NCT00837603: Physical Training in Transposition of the Great Arteries
Official title: Influence of Physical Training on Cardiopulmonary Exercise Capacity and Right Ventricular Function in Patients With D-TGA and Atrial Switch Operation.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Transposition of Great Vessels
Keywords: tga
atrial switch
training
Lead sponsor: Hannover Medical School
Sponsor class: OTHER
First posted: 2009-02-05
Enrollment: 48
Sex: ALL
Minimum age (years): 18
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Cardiac MRI Right Ventricular Ejection Fraction
timeFrame: 6 and 12 months
measure: Cardiopulmonary exercise capacity
timeFrame: 6 and 12 months
Secondary outcomes:
measure: laboratory markers of heart failure
timeFrame: 6 and 12 months
measure: Diastolic RV and LV function
timeFrame: 6 and 12 months
measure: Right ventricular volumes
timeFrame: 6 and 12 months
measure: Right ventricular mass
timeFrame: 6 and 12 months
measure: NYHA-class
timeFrame: 6 and 12 months
measure: quality of life questionnaire
timeFrame: 6 and 12 months
Other outcomes:
Locations:
city: Hannover
country: Germany
facility: Hannover Medical School
Study officials:
affiliation: Hannover Medical School
name: Philip Roentgen, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Hannover Medical School
name: Gerd P Meyer, MD
role: STUDY_CHAIR
affiliation: Hannover Medical School
name: Helmut Drexler, MD
role: STUDY_DIRECTOR
References:
citation: Westhoff-Bleck M, Schieffer B, Tegtbur U, Meyer GP, Hoy L, Schaefer A, Tallone EM, Tutarel O, Mertins R, Wilmink LM, Anker SD, Bauersachs J, Roentgen P. Aerobic training in adults after atrial switch procedure for transposition of the great arteries improves exercise capacity without impairing systemic right ventricular function. Int J Cardiol. 2013 Dec 5;170(1):24-9. doi: 10.1016/j.ijcard.2013.10.009. Epub 2013 Oct 11.
citation: Tutarel O, Rontgen P, Bode-Boger SM, Martens-Lobenhoffer J, Westhoff-Bleck M, Diller GP, Bauersachs J, Kielstein JT. Symmetrical dimethylarginine is superior to NT-proBNP for detecting systemic ventricular dysfunction in adults after atrial repair for transposition of the great arteries. Int J Cardiol. 2013 Oct 9;168(4):4415-6. doi: 10.1016/j.ijcard.2013.05.030. Epub 2013 May 24. No abstract available.