Physical Training in Transposition of the Great Arteries

Not Applicable

Completed

• Conditions: Transposition of Great Vessels
• Interventions: Behavioral: Training

• Registration Number: NCT00837603
• Lead Sponsor: Hannover Medical School

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.

Study Timeline

• Study Start: 2009-02
• Study First Submitted: 2009-02-04
• Study First Submitted QC: 2009-02-04
• Study First Posted: 2009-02-05
• Primary Completion: 2010-09
• Study Completion: 2011-01
• Status Verified: 2011-07
• Last Update Submitted: 2012-03-08
• Last Update Posted: 2012-03-09

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 48

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Training	Training	Ergometer Training

Primary Outcome Measures

Name	Time	Method
Cardiac MRI Right Ventricular Ejection Fraction	6 and 12 months
Cardiopulmonary exercise capacity	6 and 12 months

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Hannover Medical School; 🇩🇪 Hannover, Germany