Usefulness of Myocardial Deformation Imaging for Trastuzumab-induced Cardiotoxicity

NCT ID: NCT01665300

Last Updated: 2014-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

120 participants

Study Classification

OBSERVATIONAL

Study Start Date

2011-07-31

Study Completion Date

2014-04-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Left Ventricular Function Systolic Dysfunction Cardiotoxicity

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Seoul National University Hospital

OTHER

Sponsor Role lead

Responsible Party

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Hyung-Kwan Kim

MD, PhD, Assistant Professor, Seoul National University Cardiovascular center

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Hyung-Kwan Kim, M.D., PhD

Role: PRINCIPAL_INVESTIGATOR

Seoul National University Hospital

Locations

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Seoul National University Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

Other Identifiers

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H1106-026-365

Identifier Type: -

Identifier Source: org_study_id

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