Text Size

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
  Purpose

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.


Condition Intervention
Transposition of Great Vessels
 Behavioral: Training

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Diagnostic
Official Title: Influence of Physical Training on Cardiopulmonary Exercise Capacity and Right Ventricular Function in Patients With D-TGA and Atrial Switch Operation.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Hannover Medical School:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 48
Study Start Date: February 2009
Study Completion Date: January 2011
Primary Completion Date: September 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Training
Ergometer Training
 Behavioral: Training
Controlled home ergometer training
Other Names:
  • ergometer
  • physical exercise
No Intervention: 2
Counseling

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

Ages Eligible for Study:   18 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00837603

Locations
Germany
Hannover Medical School
Hannover, Germany, 30623
Sponsors and Collaborators
Hannover Medical School
Investigators
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
  More Information

No publications provided

Responsible Party: Helmut Drexler, MD, Professor of Medicine, Hannover Medical School
ClinicalTrials.gov Identifier: NCT00837603     History of Changes
Other Study ID Numbers: TGA2009
Study First Received: February 4, 2009
Last Updated: March 8, 2012
Health Authority: Germany: Federal Ministry of Education and Research

Keywords provided by Hannover Medical School:
tga
atrial switch
training

Additional relevant MeSH terms:
Situs Inversus
Transposition of Great Vessels
Congenital Abnormalities
Heart Defects, Congenital
 Cardiovascular Abnormalities
Cardiovascular Diseases
Heart Diseases

ClinicalTrials.gov processed this record on May 23, 2013