Usefulness of Myocardial Deformation Imaging in Breast Cancer Patients Treated With Trastuzumab for Early Detection of Myocardial Dysfunction
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
Hyung-Kwan Kim
MD, PhD, Assistant Professor, Seoul National University Cardiovascular center
Seoul National University Hospital