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CompletedNCT00837603TrainingTGAUpdated Mar 9, 2012

Physical Training in Transposition of the Great Arteries

An interventional study of Training in Transposition of Great Vessels, sponsored by Hannover Medical School. Completed at 1 site in Germany. Open to participants aged 18 Years to 40 Years. Per ClinicalTrials.gov, last updated 2012-03-09.

Sponsored by Hannover Medical School · Not applicable, Interventional, and Diagnostic

Phase
Not applicable
Study type
Interventional
Enrollment
48
Allocation
Randomized
Ages
18 Years to 40 Years
Sex
All
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Study 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.

Read the 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.

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Conditions studied

  • Transposition of Great Vessels

Keywords

  • tga
  • atrial switch
  • training
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In context

Transposition of Great Vessels

45 studies on the registry are indexed under Transposition of Great Vessels; 9 are open to participants now.

This study's planned enrollment of 48 is below the median of 56 across 21 interventional studies indexed under Transposition of Great Vessels.

Browse Transposition of Great Vessels studies →

Lead sponsor

Hannover Medical School is the lead sponsor of 198 studies on the registry; 24 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
All
Accepts healthy volunteers
No

Inclusion criteria

  • age >=18 years

Exclusion criteria

Exclusion Criteria:

  • tricuspid regurgitation grade 2 or more
  • sign. LVOTO or RVOTO
  • pacemaker or defibrillator
  • recent hospitalisation for heart failure (90 days)
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Study design

Phase
Not applicable
Primary purpose
Diagnostic
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Single (Outcomes assessor)
Enrollment
48 participants (estimated)

Study arms

  • Active comparator
    Training

    Ergometer Training

    Behavioral: Training

  • No intervention
    2

    Counseling

Interventions

  • BehavioralTraining

    Controlled home ergometer training

    Also known as: ergometer, physical exercise

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What researchers measure

Primary outcomes

  1. Cardiac MRI Right Ventricular Ejection Fraction

    Time frame: 6 and 12 months

  2. Cardiopulmonary exercise capacity

    Time frame: 6 and 12 months

Secondary outcomes

  1. laboratory markers of heart failure

    Time frame: 6 and 12 months

  2. Diastolic RV and LV function

    Time frame: 6 and 12 months

  3. Right ventricular volumes

    Time frame: 6 and 12 months

  4. Right ventricular mass

    Time frame: 6 and 12 months

  5. NYHA-class

    Time frame: 6 and 12 months

  6. quality of life questionnaire

    Time frame: 6 and 12 months

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Study locations

1 site
  • Hannover Medical School
    Hannover, 30623, Germany
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References and documents

Publications

  • 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. PubMed 24207068 ↗
  • 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. PubMed 23711443 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Mar 9, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00837603
Lead sponsor
Hannover Medical School
First posted
Feb 5, 2009
Start date
Feb 2009
Primary completion
Sep 2010
Completion
Jan 2011
Last update
Mar 9, 2012

Study contacts

Philip Roentgen, MD
principal investigator · Hannover Medical School
Gerd P Meyer, MD
study chair · Hannover Medical School
Helmut Drexler, MD
study director · Hannover Medical School

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jul 2011. You cannot join it, but the record below documents what was studied.

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