Physical Training in Transposition of the Great Arteries

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Brief Title

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.

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.
    


Study Type

Interventional


Primary Outcome

Cardiac MRI Right Ventricular Ejection Fraction

Secondary Outcome

 laboratory markers of heart failure

Condition

Transposition of Great Vessels

Intervention

Training

Study Arms / Comparison Groups

 Training
Description:  Ergometer Training

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information


Recruitment Status

Behavioral

Estimated Enrollment

48

Start Date

February 2009

Completion Date

January 2011

Primary Completion Date

September 2010

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)
      

Gender

All

Ages

18 Years - 40 Years

Accepts Healthy Volunteers

No

Contacts

Philip Roentgen, MD, , 

Location Countries

Germany

Location Countries

Germany

Administrative Informations


NCT ID

NCT00837603

Organization ID

TGA2009



Study Sponsor

Hannover Medical School


Study Sponsor

Philip Roentgen, MD, Principal Investigator, Hannover Medical School


Verification Date

July 2011