Clinical Trial: Usefulness of Myocardial Deformation Imaging for Trastuzumab-induced Cardiotoxicity

Study Status: Completed
Recruit Status: Completed
Study Type: Observational

Official Title: Usefulness of Myocardial Deformation Imaging in Breast Cancer Patients Treated With Trastuzumab for Early Detection of Myocardial Dysfunction

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 Summary: 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.
Sponsor: Seoul National University Hospital

Current Primary Outcome: LV systolic dysfunction [ Time Frame: 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


Original Primary Outcome: LV systolic dysfunction [ Time Frame: 3,6,9, and 12-month F/U ]

  1. An EF unit drop of ≥10% from the first available echocardiogram
  2. decrease in strain or strain rate : drop corresponding to ≥1 SD of the relevant parameter assessed at the first available echocardiogram


Current Secondary Outcome: LV systolic dysfunction [ Time Frame: 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


Original Secondary Outcome:

Information By: Seoul National University Hospital

Dates:
Date Received: December 13, 2011
Date Started: July 2011
Date Completion:
Last Updated: April 26, 2014
Last Verified: April 2014