Usefulness of Myocardial Deformation Imaging for Trastuzumab-induced Cardiotoxicity

Cardiotoxicity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01665300
• Other study ID #: H1106-026-365
• Status: Completed
• Phase: N/A
• First received: December 13, 2011
• Last updated: April 26, 2014
• Start date: July 2011
• Est. completion date: April 2014

Study information

• Verified date: April 2014
• Source: Seoul National University Hospital
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Food and Drug Administration
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 120
• Est. completion date: April 2014
• Est. primary completion date: December 2013
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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

Study Design

Observational Model: Case-Only, Time Perspective: Prospective

Related Conditions & MeSH terms

• Cardiotoxicity
• Left Ventricular Function Systolic Dysfunction

Locations

Country	Name	City	State
Korea, Republic of	Seoul National University Hospital	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	LV systolic dysfunction	LV systolic dysfunction was defined as following; An EF unit drop of =10% from the baseline available echocardiogram or; Change in strain or strain rate : drop(decrement) corresponding to =1 SD of the relevant parameter assessed at the baseline available echocardiogram	3-month F/U	No
Secondary	LV systolic dysfunction	LV systolic dysfunction was defined as following; An EF unit drop of =10% from the baseline available echocardiogram or; Change in strain or strain rate : drop(decrement) corresponding to =1 SD of the relevant parameter assessed at the baseline available echocardiogram	6,9, and 12-month F/U	No