Physical Training in Transposition of the Great Arteries (TrainingTGA)

March 8, 2012 updated by: Hannover Medical School

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Anticipated)

48

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Hannover, Germany, 30623
        • Hannover Medical School

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Training
Ergometer Training
Behavioral: Training
Controlled home ergometer training
Other Names:
  • physical exercise
  • ergometer
No Intervention: 2
Counseling

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Cardiac MRI Right Ventricular Ejection Fraction
Time Frame: 6 and 12 months
6 and 12 months
Cardiopulmonary exercise capacity
Time Frame: 6 and 12 months
6 and 12 months

Secondary Outcome Measures

Outcome Measure
Time Frame
laboratory markers of heart failure
Time Frame: 6 and 12 months
6 and 12 months
Diastolic RV and LV function
Time Frame: 6 and 12 months
6 and 12 months
Right ventricular volumes
Time Frame: 6 and 12 months
6 and 12 months
Right ventricular mass
Time Frame: 6 and 12 months
6 and 12 months
NYHA-class
Time Frame: 6 and 12 months
6 and 12 months
quality of life questionnaire
Time Frame: 6 and 12 months
6 and 12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hannover Medical School

Investigators

  • Principal Investigator: Philip Roentgen, MD, Hannover Medical School
  • Study Chair: Gerd P Meyer, MD, Hannover Medical School

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

February 1, 2009

Primary Completion (Actual)

September 1, 2010

Study Completion (Actual)

January 1, 2011

Study Registration Dates

First Submitted

February 4, 2009

First Submitted That Met QC Criteria

February 4, 2009

First Posted (Estimate)

February 5, 2009

Study Record Updates

Last Update Posted (Estimate)

March 9, 2012

Last Update Submitted That Met QC Criteria

March 8, 2012

Last Verified

July 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TGA2009

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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