NCT01430897

Brief Summary

Systemic RV hypertrophy and impaired systolic function occur after atrial switch (AS) in d-transposition of the great arteries (d-TGA). Echocardiography has limitation in the assessment of the right ventricle (RV). In this study the investigators sought to evaluate systemic RV myocardial mass and function after AS for d-TGA and to analyze the role of excessive hypertrophy for ventricular function under special consideration of the interventricular septal (IVS) movement.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2007

Longer than P75 for all trials

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

April 1, 2007

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2011

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
4 days until next milestone

First Submitted

Initial submission to the registry

September 5, 2011

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 8, 2011

Completed
Last Updated

September 8, 2011

Status Verified

September 1, 2011

Enrollment Period

4 years

First QC Date

September 5, 2011

Last Update Submit

September 7, 2011

Conditions

Right Ventricular Hypertrophyd-TGA

Keywords

d-TGAdextro Transposition of the great arteriessystemic right ventricleright ventricular failureAtrial switch procedure

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

Thirty-seven consecutive patients who came to regular outpatient visits at our tertiary care institution were referred to CMR. Patient parameters were compared to a control group of 25 healthy age matched volunteers.

You may qualify if:

  • Eligibility criteria were an AS operation in childhood for correction of d-TGA and the absence of associated hemodynamically significant heart defects.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Leipzig - Heart Center

Leipzig, 04289, Germany

Location

Related Publications (1)

  • Hornung TS, Kilner PJ, Davlouros PA, Grothues F, Li W, Gatzoulis MA. Excessive right ventricular hypertrophic response in adults with the mustard procedure for transposition of the great arteries. Am J Cardiol. 2002 Oct 1;90(7):800-3. doi: 10.1016/s0002-9149(02)02619-x. No abstract available.

    PMID: 12356407RESULT

MeSH Terms

Conditions

Hypertrophy, Right VentricularHeart Failure

Condition Hierarchy (Ancestors)

CardiomegalyHeart DiseasesCardiovascular DiseasesHypertrophyPathological Conditions, AnatomicalPathological Conditions, Signs and Symptoms

Study Officials

  • Matthias Gutberlet, MD

    University pf Leipzig - Heart Center

    STUDY CHAIR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Consultant Radiology

Study Record Dates

First Submitted

September 5, 2011

First Posted

September 8, 2011

Study Start

April 1, 2007

Primary Completion

April 1, 2011

Study Completion

September 1, 2011

Last Updated

September 8, 2011

Record last verified: 2011-09

Locations

DE(1)