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Physical Training in Transposition of the Great Arteries (TrainingTGA)

Primary Purpose

Transposition of Great Vessels

Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
Training
Sponsored by
Hannover Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Transposition of Great Vessels focused on measuring tga, atrial switch, training

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesDoes not accept healthy volunteers

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)

Sites / Locations

  • Hannover Medical School

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Training

2

Arm Description

Ergometer Training

Counseling

Outcomes

Primary Outcome Measures

Cardiac MRI Right Ventricular Ejection Fraction
Cardiopulmonary exercise capacity

Secondary Outcome Measures

laboratory markers of heart failure
Diastolic RV and LV function
Right ventricular volumes
Right ventricular mass
NYHA-class
quality of life questionnaire

Full Information

First Posted
February 4, 2009
Last Updated
March 8, 2012
Sponsor
Hannover Medical School
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1. Study Identification

Unique Protocol Identification Number
NCT00837603
Brief Title
Physical Training in Transposition of the Great Arteries
Acronym
TrainingTGA
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

2. Study Status

Record Verification Date
July 2011
Overall Recruitment Status
Completed
Study Start Date
February 2009 (undefined)
Primary Completion Date
September 2010 (Actual)
Study Completion Date
January 2011 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
Hannover Medical School

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Transposition of Great Vessels
Keywords
tga, atrial switch, training

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Training
Arm Type
Active Comparator
Arm Description
Ergometer Training
Arm Title
2
Arm Type
No Intervention
Arm Description
Counseling
Intervention Type
Behavioral
Intervention Name(s)
Training
Other Intervention Name(s)
ergometer, physical exercise
Intervention Description
Controlled home ergometer training
Primary Outcome Measure Information:
Title
Cardiac MRI Right Ventricular Ejection Fraction
Time Frame
6 and 12 months
Title
Cardiopulmonary exercise capacity
Time Frame
6 and 12 months
Secondary Outcome Measure Information:
Title
laboratory markers of heart failure
Time Frame
6 and 12 months
Title
Diastolic RV and LV function
Time Frame
6 and 12 months
Title
Right ventricular volumes
Time Frame
6 and 12 months
Title
Right ventricular mass
Time Frame
6 and 12 months
Title
NYHA-class
Time Frame
6 and 12 months
Title
quality of life questionnaire
Time Frame
6 and 12 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
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)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Philip Roentgen, MD
Organizational Affiliation
Hannover Medical School
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Gerd P Meyer, MD
Organizational Affiliation
Hannover Medical School
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Helmut Drexler, MD
Organizational Affiliation
Hannover Medical School
Official's Role
Study Director
Facility Information:
Facility Name
Hannover Medical School
City
Hannover
ZIP/Postal Code
30623
Country
Germany

12. IPD Sharing Statement

Citations:
PubMed Identifier
24207068
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.
Results Reference
derived
PubMed Identifier
23711443
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.
Results Reference
derived

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Physical Training in Transposition of the Great Arteries

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