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Right Ventricular Hypertrophy After Atrial Switch and Cardiovascular Magnetic Resonance (CMR) Findings

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Matthias Grothoff, M.D., University of Leipzig
ClinicalTrials.gov Identifier:
NCT01430897
First received: September 5, 2011
Last updated: September 7, 2011
Last verified: September 2011
History of Changes
  Purpose

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.


Condition
Right Ventricular Hypertrophy
d-TGA

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Right Ventricular Hypertrophy After Atrial Switch Operation and Its Role in a Systemic RV: Normal Adaptation Process or Risk Factor? A Cardiovascular Magnetic Resonance Study

Further study details as provided by University of Leipzig:

Enrollment: 37
Study Start Date: April 2007
Study Completion Date: September 2011
Primary Completion Date: April 2011 (Final data collection date for primary outcome measure)
  Eligibility

Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability 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.

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Exclusion criteria were usual CMR contraindications such as ferromagnetic metallic implants.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01430897

Locations
Germany
University of Leipzig - Heart Center
Leipzig, Germany, 04289
Sponsors and Collaborators
University of Leipzig
Investigators
Study Chair: Matthias Gutberlet, MD University pf Leipzig - Heart Center
  More Information

Publications:

Responsible Party: Matthias Grothoff, M.D., Consultant Radiology, University of Leipzig
ClinicalTrials.gov Identifier: NCT01430897     History of Changes
Other Study ID Numbers: 261-11-22082011
Study First Received: September 5, 2011
Last Updated: September 7, 2011
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by University of Leipzig:
d-TGA
dextro Transposition of the great arteries
systemic right ventricle
right ventricular failure
Atrial switch procedure

Additional relevant MeSH terms:
Hypertrophy
Hypertrophy, Right Ventricular
Pathological Conditions, Anatomical
 Cardiomegaly
Heart Diseases
Cardiovascular Diseases

ClinicalTrials.gov processed this record on May 16, 2013