Physical Training in Transposition of the Great Arteries | NCT00837603

Studies
Physical Training in Transposition of the Great Arteries

NCT00837603

Sponsor

Hannover Medical School

Status

Completed

Last Update Posted

Mar 9, 2012Estimated

Enrollment

48Estimated

Phase

Not Applicable

Conditions

Transposition of Great Vessels

Interventions

Training

Countries

Germany

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jul 2011

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2009

Primary Completion Date

Sep 2010Actual

Completion Date

Jan 2011Actual

First Submitted Date

Feb 4, 2009

First Submission Date that Met QC Criteria

Feb 4, 2009

First Posted Date

Feb 5, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 8, 2012

Last Update Posted Date

Mar 9, 2012Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Not provided

Lead Sponsor

Hannover Medical SchoolOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

48Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Training	Active Comparator	Ergometer Training	Behavioral: Training
2	No Intervention	Counseling

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Training	Behavioral	Controlled home ergometer training	Training	ergometer

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
laboratory markers of heart failure		6 and 12 months
Diastolic RV and LV function		6 and 12 months
Right ventricular volumes

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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)

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

40 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Philip Roentgen, MD	Hannover Medical School	Principal Investigator
Gerd P Meyer, MD	Hannover Medical School	Study Chair
Helmut Drexler, MD	Hannover Medical School	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Hannover Medical School		Hanover		30623	Germany

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
24207068	Derived	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.
23711443

ID	Term
D014188	Transposition of Great Vessels
D004062	DiGeorge Syndrome

ID	Term
D006330	Heart Defects, Congenital
D018376	Cardiovascular Abnormalities
D002318	Cardiovascular Diseases
D006331	Heart Diseases

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena