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Usefulness of Myocardial Deformation Imaging for Trastuzumab-induced Cardiotoxicity

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ClinicalTrials.gov Identifier: NCT01665300
Recruitment Status : Completed
First Posted : August 15, 2012
Last Update Posted : April 29, 2014
Sponsor:
Information provided by (Responsible Party):
Hyung-Kwan Kim, Seoul National University Hospital

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.

Condition or disease
Left Ventricular Function Systolic Dysfunction Cardiotoxicity

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
Actual Enrollment : 120 participants
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
Study Start Date : July 2011
Actual Primary Completion Date : December 2013
Actual Study Completion Date : April 2014

Resource links provided by the National Library of Medicine

Drug Information available for: Trastuzumab




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Biospecimen Retention:   Samples With DNA
genetic susceptibility for HER2(+)cardiotoxicity


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01665300


Locations
Korea, Republic of
Seoul National University Hospital
Seoul, Korea, Republic of, 110-744
Sponsors and Collaborators
Seoul National University Hospital
Investigators
Principal Investigator: Hyung-Kwan Kim, M.D., PhD Seoul National University Hospital

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
First Posted: August 15, 2012    Key Record Dates
Last Update Posted: April 29, 2014
Last Verified: April 2014

Keywords provided by Hyung-Kwan Kim, Seoul National University Hospital:
myocardial deformation imaging
Trastuzumab

Additional relevant MeSH terms:
Cardiotoxicity
Pathologic Processes
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Radiation Injuries
Wounds and Injuries
Trastuzumab
Antineoplastic Agents