Usefulness of Myocardial Deformation Imaging for Trastuzumab-induced Cardiotoxicity

April 26, 2014 updated by: Hyung-Kwan Kim, Seoul National University Hospital

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

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.

Study Overview

Status

Completed

Conditions

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 Type

Observational

Enrollment (Actual)

120

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 110-744
        • Seoul National University Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

The investigators evaluated serial echocardiograms (baseline, 3, 6, 9, and 12 months)from 120 consecutive female patients receiving trastuzumab as part of their treatment for either early or advanced breast cancer.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
3-month F/U

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6,9, and 12-month F/U

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Seoul National University Hospital

Investigators

  • Principal Investigator: Hyung-Kwan Kim, M.D., PhD, Seoul National University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2011

Primary Completion (Actual)

December 1, 2013

Study Completion (Actual)

April 1, 2014

Study Registration Dates

First Submitted

December 13, 2011

First Submitted That Met QC Criteria

August 13, 2012

First Posted (Estimate)

August 15, 2012

Study Record Updates

Last Update Posted (Estimate)

April 29, 2014

Last Update Submitted That Met QC Criteria

April 26, 2014

Last Verified

April 1, 2014

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • H1106-026-365

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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