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

December 13, 2011
April 11, 2013
July 2011
June 2013   (final data collection date for primary outcome measure)
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
LV systolic dysfunction [ Time Frame: 3,6,9, and 12-month F/U ] [ Designated as safety issue: No ]
  1. an EF unit drop of ≥10% from the first available echocardiogram
  2. decrease in strain or strain rate : drop corresponding to ≥1 SD of the relevant parameter assessed at the first available echocardiogram
Complete list of historical versions of study NCT01665300 on ClinicalTrials.gov Archive Site
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
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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

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.

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.

Observational
Observational Model: Case-Only
Time Perspective: Prospective
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Retention:   Samples With DNA
Description:

genetic susceptibility for HER2(+)cardiotoxicity

Non-Probability Sample

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.

  • Left Ventricular Function Systolic Dysfunction
  • Cardiotoxicity
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
120
December 2013
June 2013   (final data collection date for primary outcome measure)

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
Female
18 Years to 75 Years
No
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
Korea, Republic of
 
NCT01665300
H1106-026-365
No
Hyung-Kwan Kim, Seoul National University Hospital
Seoul National University Hospital
Not Provided
Principal Investigator: Hyung-Kwan Kim, M.D., PhD Seoul National University Hospital
Seoul National University Hospital
April 2013

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP