NCT00837603

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Feb 2009

Typical duration for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2009

Completed
3 days until next milestone

First Submitted

Initial submission to the registry

February 4, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 5, 2009

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2011

Completed
Last Updated

March 9, 2012

Status Verified

July 1, 2011

Enrollment Period

1.6 years

First QC Date

February 4, 2009

Last Update Submit

March 8, 2012

Conditions

Transposition of Great Vessels

Keywords

tgaatrial switchtraining

Outcome Measures

Primary Outcomes (2)

  • Cardiac MRI Right Ventricular Ejection Fraction

    6 and 12 months

  • Cardiopulmonary exercise capacity

    6 and 12 months

Secondary Outcomes (6)

  • 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

  • +1 more secondary outcomes

Study Arms (2)

Training

ACTIVE COMPARATOR

Ergometer Training

Behavioral: Training

2

NO INTERVENTION

Counseling

Interventions

TrainingBEHAVIORAL

Controlled home ergometer training

Also known as: ergometer, physical exercise
Training

Eligibility Criteria

Age18 Years - 40 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • age \>=18 years

You may not qualify if:

  • tricuspid regurgitation grade 2 or more
  • sign. LVOTO or RVOTO
  • pacemaker or defibrillator
  • recent hospitalisation for heart failure (90 days)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hannover Medical School

Hanover, 30623, Germany

Location

Related Publications (2)

  • 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.

    PMID: 24207068DERIVED

  • 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.

    PMID: 23711443DERIVED

MeSH Terms

Conditions

Transposition of Great VesselsDiGeorge Syndrome

Interventions

Exercise

Condition Hierarchy (Ancestors)

Heart Defects, CongenitalCardiovascular AbnormalitiesCardiovascular DiseasesHeart DiseasesCongenital AbnormalitiesCongenital, Hereditary, and Neonatal Diseases and Abnormalities22q11 Deletion SyndromeCraniofacial AbnormalitiesMusculoskeletal AbnormalitiesMusculoskeletal DiseasesLymphatic AbnormalitiesLymphatic DiseasesHemic and Lymphatic DiseasesAbnormalities, MultipleChromosome DisordersGenetic Diseases, InbornHypoparathyroidismParathyroid DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Study Officials

  • 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

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
DIAGNOSTIC
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

February 4, 2009

First Posted

February 5, 2009

Study Start

February 1, 2009

Primary Completion

September 1, 2010

Study Completion

January 1, 2011

Last Updated

March 9, 2012

Record last verified: 2011-07

Locations

DE(1)