Usefulness of Myocardial Deformation Imaging for Trastuzumab-induced Cardiotoxicity
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Purpose
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 |
|---|
|
Left Ventricular Function Systolic Dysfunction Cardiotoxicity |
| Study Type: | Observational |
| Study Design: | 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 |
- LV systolic dysfunction [ Time Frame: 3-month F/U ] [ Designated as safety issue: No ]
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
- LV systolic dysfunction [ Time Frame: 6,9, and 12-month F/U ] [ Designated as safety issue: No ]
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
Biospecimen Retention: Samples With DNA
genetic susceptibility for HER2(+)cardiotoxicity
| Estimated Enrollment: | 120 |
| Study Start Date: | July 2011 |
| Estimated Study Completion Date: | December 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
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.
Eligibility| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
| Sampling Method: | 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.
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
Contacts and Locations| 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 | |
| Seoul National University Hospital | Recruiting |
| Seoul, Korea, Republic of, 110-744 | |
| 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 | |
| Principal Investigator: Hyung-Kwan Kim, M.D., Ph.D. | |
| Sub-Investigator: Ji-Hyun Kim, M.D. | |
| Principal Investigator: | Hyung-Kwan Kim, M.D., PhD | Seoul National University Hospital |
More Information
No publications provided
| 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 |
| Study First Received: | December 13, 2011 |
| Last Updated: | April 11, 2013 |
| Health Authority: | Korea: Food and Drug Administration |
Keywords provided by Seoul National University Hospital:
|
myocardial deformation imaging Trastuzumab |
Additional relevant MeSH terms:
|
Trastuzumab Antineoplastic Agents Therapeutic Uses Pharmacologic Actions |
ClinicalTrials.gov processed this record on May 22, 2013