Usefulness of Myocardial Deformation Imaging for Trastuzumab-induced Cardiotoxicity

NCT01665300 | Completed

• 1 other identifier: H1106-026-365
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

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.

Conditions

Left Ventricular Function Systolic Dysfunction; Cardiotoxicity

Keywords

myocardial deformation imaging; Trastuzumab

Outcome Measures

Primary Outcomes (1)

• LV systolic dysfunction

  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

  3-month F/U

Secondary Outcomes (1)

• LV systolic dysfunction

  6,9, and 12-month F/U

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• HER2(+) breast cancer, anticipating Trastuzumab therapy

You may not qualify if:

• Refusal to informed consent
• Congenital heart disease
• Significant arrhythmia in EKG
• Regional wall motion abnormality (+) in echocardiography
• Poor sonic window

Sponsors & Collaborators

• Seoul National University Hospital: lead

Study Sites (1)

Seoul National University Hospital

Seoul, 110-744, South Korea

Location

Biospecimen

Retention: SAMPLES WITH DNA

genetic susceptibility for HER2(+)cardiotoxicity

MeSH Terms

Conditions

Cardiotoxicity

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Drug-Related Side Effects and Adverse Reactions; Chemically-Induced Disorders; Radiation Injuries; Wounds and Injuries

Study Officials

• Hyung-Kwan Kim, M.D., PhD

  Seoul National University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD, PhD, Assistant Professor, Seoul National University Cardiovascular center

Study Record Dates

• First Submitted: December 13, 2011
• First Posted: August 15, 2012
• Study Start: July 1, 2011
• Primary Completion: December 1, 2013
• Study Completion: April 1, 2014
• Last Updated: April 29, 2014

Record last verified: 2014-04

Locations

KR (1)