Physical Training in Transposition of the Great Arteries

Transposition of Great Vessels Clinical Trial

— TrainingTGA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00837603
• Other study ID #: TGA2009
• Status: Completed
• Phase: N/A
• First received: February 4, 2009
• Last updated: March 8, 2012
• Start date: February 2009
• Est. completion date: January 2011

Study information

• Verified date: July 2011
• Source: Hannover Medical School
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Ministry of Education and Research
• Study type: Interventional

Clinical 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 patients with normal anatomy. Furthermore it is not known, whether these TGA-patients benefit from training with respect to cardiopulmonary exercise capacity.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: January 2011
• Est. primary completion date: September 2010
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 40 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Safety Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Transposition of Great Vessels

Intervention

Behavioral:
• Training
Controlled home ergometer training

Locations

Country	Name	City	State
Germany	Hannover Medical School	Hannover

Sponsors (1)

Lead Sponsor	Collaborator
Hannover Medical School

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Cardiac MRI Right Ventricular Ejection Fraction		6 and 12 months	Yes
Primary	Cardiopulmonary exercise capacity		6 and 12 months	Yes
Secondary	laboratory markers of heart failure		6 and 12 months	Yes
Secondary	Diastolic RV and LV function		6 and 12 months	Yes
Secondary	Right ventricular volumes		6 and 12 months	Yes
Secondary	Right ventricular mass		6 and 12 months	No
Secondary	NYHA-class		6 and 12 months	No
Secondary	quality of life questionnaire		6 and 12 months	No