Usefulness of Myocardial Deformation Imaging for Trastuzumab-induced Cardiotoxicity

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01665300

Enrollment

120

Registered

2012-08-15

Start date

2011-07-31

Completion date

2014-04-30

Last updated

2014-04-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cardiotoxicity, Left Ventricular Function Systolic Dysfunction

Keywords

myocardial deformation imaging, Trastuzumab

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.

Interventions

None listed

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 75 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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

Countries

South Korea

Outcome results