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Clinical Trials/NCT01665300
NCT01665300CompletedNot Applicable

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

Seoul National University Hospital1 site in 1 country120 target enrollmentStarted: July 2011Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
120
Locations
1
Primary Endpoint
LV systolic dysfunction

Study Overview

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.

Study Design

Study Type
Observational
Observational Model
Case Only
Time Perspective
Prospective

Eligibility Criteria

Ages
18 Years to 75 Years (Adult, Older Adult)
Sex
Female
Accepts Healthy Volunteers
No

Inclusion Criteria

  • HER2(+) breast cancer, anticipating Trastuzumab therapy

Exclusion Criteria

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

Outcomes

Primary Outcomes

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

Secondary Outcomes

  • LV systolic dysfunction(6,9, and 12-month F/U)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Hyung-Kwan Kim

MD, PhD, Assistant Professor, Seoul National University Cardiovascular center

Seoul National University Hospital

Study Sites (1)

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