Usefulness of Myocardial Deformation Imaging for Trastuzumab-induced Cardiotoxicity

Completed

• Conditions: Left Ventricular Function Systolic Dysfunction; Cardiotoxicity

• Registration Number: NCT01665300
• Lead Sponsor: Seoul National University Hospital

Brief Summary

Trastuzumab prolongs survival in patients with human epidermal growth factor receptor type 2-positive breast cancer. Sequential left ventricular (LV) ejection fraction (EF) assessment has been mandated to detect myocardial dysfunction because of the risk of heart failure with this treatment. Myocardial deformation imaging is a sensitive means of detecting LV dysfunction, but this technique has not been evaluated in patients treated with trastuzumab. The aim of this study was to investigate whether changes in tissue deformation, assessed by myocardial strain and strain rate (SR), are able to identify LV dysfunction earlier than conventional echocardiographic measures in patients treated with trastuzumab.

Detailed Description

The investigators will prospectively evaluate whether changes in tissue deformation, assessed by myocardial strain and strain rate (SR) and identify possibility of early detection of LV dysfunction in patients treated with trastuzumab.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-07
• Study First Submitted: 2011-12-13
• Study First Submitted QC: 2012-08-13
• Study First Posted: 2012-08-15
• Primary Completion: 2013-12
• Status Verified: 2014-04
• Study Completion: 2014-04
• Last Update Submitted: 2014-04-26
• Last Update Posted: 2014-04-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

• HER2(+) breast cancer, anticipating Trastuzumab therapy

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Exclusion Criteria

• Refusal to informed consent
• Congenital heart disease
• Significant arrhythmia in EKG
• Regional wall motion abnormality (+) in echocardiography
• Poor sonic window

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
LV systolic dysfunction	3-month F/U	LV systolic dysfunction was defined as following; 1. An EF unit drop of ≥10% from the baseline available echocardiogram or; 2. Change in strain or strain rate : drop(decrement) corresponding to ≥1 SD of the relevant parameter assessed at the baseline available echocardiogram

Secondary Outcome Measures

Name	Time	Method
LV systolic dysfunction	6,9, and 12-month F/U	LV systolic dysfunction was defined as following; 1. An EF unit drop of ≥10% from the baseline available echocardiogram or; 2. Change in strain or strain rate : drop(decrement) corresponding to ≥1 SD of the relevant parameter assessed at the baseline available echocardiogram

Trial Locations

Locations (1)

Seoul National University Hospital; 🇰🇷 Seoul, Korea, Republic of