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

Right Ventricular Hypertrophy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01430897
• Other study ID #: 261-11-22082011
• Status: Completed
• Phase: N/A
• First received: September 5, 2011
• Last updated: September 7, 2011
• Start date: April 2007
• Est. completion date: September 2011

Study information

• Verified date: September 2011
• Source: University of Leipzig
• Contact: n/a
• Is FDA regulated: No
• Health authority: Germany: Federal Institute for Drugs and Medical Devices
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 37
• Est. completion date: September 2011
• Est. primary completion date: April 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: N/A and older

Eligibility

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.

Study Design

Observational Model: Cohort, Time Perspective: Retrospective

Related Conditions & MeSH terms

• d-TGA
• Hypertrophy
• Right Ventricular Hypertrophy

Locations

Country	Name	City	State
Germany	University of Leipzig - Heart Center	Leipzig

Sponsors (1)

Lead Sponsor	Collaborator
University of Leipzig

Country where clinical trial is conducted

Germany, 

References & 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. — View Citation