Transposition of Great VesselsTrainingTGANCT00837603
Physical Training in Transposition of the Great Arteries
A study testing Training in people with Transposition of Great Vessels, run by Hannover Medical School at 1 site in Germany.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Transposition of Great Vessels
- What is being tested?
- Training
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 48 participants
- Where
- 1 siteGermany
- Study dates
- Feb 2009to Jan 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- age >=18 years
Who cannot join
- tricuspid regurgitation grade 2 or more
- sign. LVOTO or RVOTO
- pacemaker or defibrillator
- recent hospitalisation for heart failure (90 days)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Transposition of Great Vessels
- Being tested
- Training
- Keywords
- tga, atrial switch, training
- Medical subject headings
- Transposition of Great Vessels, DiGeorge Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrainingBehavioural
Also called ergometer, physical exercise
Controlled home ergometer training
| Study group | Role | What they receive |
|---|---|---|
| Training | Active comparator | Ergometer Training Receives: Behavioral: Training |
| 2 | No intervention | Counseling |
What is being measured
The primary outcome is the main question the study is designed to answer.
Cardiac MRI Right Ventricular Ejection Fraction
Measured: 6 and 12 months
Cardiopulmonary exercise capacity
Measured: 6 and 12 months
Secondary outcomes (6)
laboratory markers of heart failure
Measured: 6 and 12 months
Diastolic RV and LV function
Measured: 6 and 12 months
Right ventricular volumes
Measured: 6 and 12 months
Right ventricular mass
Measured: 6 and 12 months
NYHA-class
Measured: 6 and 12 months
quality of life questionnaire
Measured: 6 and 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionSep 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Transposition of Great VesselsStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 48 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hannover Medical School
- Sponsor type
- University, hospital or other
- Investigators
- Philip Roentgen, MD, Principal investigator, Hannover Medical SchoolGerd P Meyer, MD, Study chair, Hannover Medical SchoolHelmut Drexler, MD, Study director, Hannover Medical School
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00837603
- Sponsor's protocol ID
- TGA2009
- Acronym
- TrainingTGA
- Status last verified
- Jul 2011
- First submitted
- 4 Feb 2009
- Last updated
- 9 Mar 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 24207068Tutarel 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.
PubMed 23711443
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of Physical Training on Cardiopulmonary Exercise Capacity and Right Ventricular Function in Patients With D-TGA and Atrial Switch Operation.
- ClinicalTrials.gov ID
- NCT00837603
- Acronym / sponsor ID
- TrainingTGA / TGA2009
- Conditions
- Transposition of Great Vessels
- Keywords
- tga, atrial switch, training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 48 participants (estimated)
- Lead sponsor
- Hannover Medical SchoolUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Sep 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 5 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training | Active comparator | Behavioral: TrainingErgometer Training |
| 2 | No intervention | –Counseling |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- age >=18 years
Key exclusion criteria (4 listed)
- tricuspid regurgitation grade 2 or more
- sign. LVOTO or RVOTO
- pacemaker or defibrillator
- recent hospitalisation for heart failure (90 days)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TrainingAlso: ergometer, physical exerciseControlled home ergometer training | Behavioural | Training |
Primary outcome
Cardiac MRI Right Ventricular Ejection Fraction
Time frame: 6 and 12 months
Cardiopulmonary exercise capacity
Time frame: 6 and 12 months
6 secondary outcomes
laboratory markers of heart failure
Time frame: 6 and 12 months
Diastolic RV and LV function
Time frame: 6 and 12 months
Right ventricular volumes
Time frame: 6 and 12 months
Right ventricular mass
Time frame: 6 and 12 months
NYHA-class
Time frame: 6 and 12 months
quality of life questionnaire
Time frame: 6 and 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2012.
- Derived from this study: PubMed 24207068Westhoff-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.
- Derived from this study: PubMed 23711443Tutarel 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Philip Roentgen, MD principal investigator
Hannover Medical School
Gerd P Meyer, MD study chair
Hannover Medical School
Helmut Drexler, MD study director
Hannover Medical School
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Training in people with Transposition of Great Vessels, run by Hannover Medical School at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Mar 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Cardiac MRI Right Ventricular Ejection Fraction (time frame: 6 and 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00837603, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Mar 2012.