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Completed

NCT Number: NCT01665300

Usefulness of Myocardial Deformation Imaging for Trastuzumab-induced Cardiotoxicity

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.

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Key information

Conditions

Left Ventricular Function Systolic Dysfunction Cardiotoxicity Cardiovascular Diseases Chemically-Induced Disorders Drug-Related Side Effects and Adverse Reactions Heart Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Radiation Injuries Wounds and Injuries

Age range

18 year–75 year

Sex eligibility

Female

Study type

Observational

Primary location

Seoul National University Hospital

Seoul, 110-744, South Korea

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. LV systolic dysfunction

    Time frame: 3-month F/U

    LV systolic dysfunction was defined as following;

    • An EF unit drop of ≥10% from the baseline available echocardiogram or
    • Change in strain or strain rate : drop(decrement) corresponding to ≥1 SD of the relevant parameter assessed at the baseline available echocardiogram

Secondary outcomes

  1. LV systolic dysfunction

    Time frame: 6,9, and 12-month F/U

    LV systolic dysfunction was defined as following;

    • An EF unit drop of ≥10% from the baseline available echocardiogram or
    • Change in strain or strain rate : drop(decrement) corresponding to ≥1 SD of the relevant parameter assessed at the baseline available echocardiogram

Sponsors and collaborators

Lead sponsor

Seoul National University Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2013
Study completion
2014
First posted
Aug 15, 2012
Registry last updated
Apr 29, 2014

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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