Usefulness of Myocardial Deformation Imaging for Trastuzumab-induced Cardiotoxicity

This study is currently recruiting participants.
Verified April 2013 by Seoul National University Hospital
Sponsor:
Information provided by (Responsible Party):
Hyung-Kwan Kim, Seoul National University Hospital
ClinicalTrials.gov Identifier:
NCT01665300
First received: December 13, 2011
Last updated: April 11, 2013
Last verified: April 2013
  Purpose

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.


Condition
Left Ventricular Function Systolic Dysfunction
Cardiotoxicity

Study Type: Observational
Study Design: Observational Model: Case-Only
Time Perspective: Prospective
Official Title: Usefulness of Myocardial Deformation Imaging in Breast Cancer Patients Treated With Trastuzumab for Early Detection of Myocardial Dysfunction

Resource links provided by NLM:


Further study details as provided by Seoul National University Hospital:

Primary Outcome Measures:
  • LV systolic dysfunction [ Time Frame: 3-month F/U ] [ Designated as safety issue: No ]

    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 Outcome Measures:
  • LV systolic dysfunction [ Time Frame: 6,9, and 12-month F/U ] [ Designated as safety issue: No ]

    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


Biospecimen Retention:   Samples With DNA

genetic susceptibility for HER2(+)cardiotoxicity


Estimated Enrollment: 120
Study Start Date: July 2011
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
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.

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Criteria

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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01665300

Contacts
Contact: Ji-Hyun Kim, M.D. 82-2-2072-3757 mdangela79@gmail.com
Contact: Hyung-Kwan KIm, M.D., Ph.D. 82-2-2072-0243 cardiman73@gmail.com

Locations
Korea, Republic of
Seoul National University Hospital Recruiting
Seoul, Korea, Republic of, 110-744
Contact: Ji-Hyun Kim, M.D.    82-2-2072-3757    mdangela79@gmail.com   
Contact: Hyung-Kwan Kim, M.D., Ph.D.    82-2-2072-0243    cardiman73@gmail.com   
Principal Investigator: Hyung-Kwan Kim, M.D., Ph.D.         
Sub-Investigator: Ji-Hyun Kim, M.D.         
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Hyung-Kwan Kim, M.D., PhD Seoul National University Hospital
  More Information

No publications provided

Responsible Party: Hyung-Kwan Kim, MD, PhD, Assistant Professor, Seoul National University Cardiovascular center, Seoul National University Hospital
ClinicalTrials.gov Identifier: NCT01665300     History of Changes
Other Study ID Numbers: H1106-026-365
Study First Received: December 13, 2011
Last Updated: April 11, 2013
Health Authority: Korea: Food and Drug Administration

Keywords provided by Seoul National University Hospital:
myocardial deformation imaging
Trastuzumab

Additional relevant MeSH terms:
Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014