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Completed

NCT Number: NCT00837603

Physical Training in Transposition of the Great Arteries

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.

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Key information

Conditions

Transposition of Great Vessels 22q11 Deletion Syndrome Abnormalities, Multiple Cardiovascular Abnormalities Cardiovascular Diseases Chromosome Disorders Congenital Abnormalities Congenital, Hereditary, and Neonatal Diseases and Abnormalities Craniofacial Abnormalities DiGeorge Syndrome Endocrine System Diseases Genetic Diseases, Inborn Heart Defects, Congenital Heart Diseases Hemic and Lymphatic Diseases Hypoparathyroidism Lymphatic Abnormalities Lymphatic Diseases Musculoskeletal Abnormalities Musculoskeletal Diseases Parathyroid Diseases

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hannover Medical School

Hanover, 30623, Germany

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

Training

Behavioral

Controlled home ergometer training

Other names: ergometer, physical exercise

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

Sponsors and collaborators

Lead sponsor

Hannover Medical School

Other

Registry information

Official study title

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

Acronym: TrainingTGA

Important dates

Study start
2009
Primary completion
2010
Study completion
2011
First posted
Feb 5, 2009
Registry last updated
Mar 9, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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