Physical Training in Transposition of the Great Arteries

NCT ID: NCT00837603

Last Updated: 2012-03-09

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2009-02-28

Study Completion Date

2011-01-31

Brief Summary

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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

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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

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Transposition of Great Vessels

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Training

Ergometer Training

Group Type ACTIVE_COMPARATOR

Training

Intervention Type BEHAVIORAL

Controlled home ergometer training

2

Counseling

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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Training

Controlled home ergometer training

Intervention Type BEHAVIORAL

Other Intervention Names

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ergometer physical exercise

Eligibility Criteria

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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)
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Hannover Medical School

OTHER

Sponsor Role lead

Responsible Party

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Hannover Medical School

Principal Investigators

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Philip Roentgen, MD

Role: PRINCIPAL_INVESTIGATOR

Hannover Medical School

Gerd P Meyer, MD

Role: STUDY_CHAIR

Hannover Medical School

Helmut Drexler, MD

Role: STUDY_DIRECTOR

Hannover Medical School

Locations

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Hannover Medical School

Hanover, , Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 24207068 (View on PubMed)

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.

Reference Type DERIVED
PMID: 23711443 (View on PubMed)

Other Identifiers

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TGA2009

Identifier Type: -

Identifier Source: org_study_id

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