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Comparing preventive effect of myocardial global longitudinal strain-based cardioprotective stragety (angiotensin receptor blocker prophylaxis) with left ventricular ejection fraction-based strategy in breast cancer patients treated with adjuvant trastuzumab.
Despite the left ventricular global longitudinal strain (GLS) enables early prediction of trastuzumab-related cardiomyopathy, its clinical application has been hampered due to the lack of appropriate evaluation and treatment strategies. Therefore, we aimed to evaluate the effect of early intervention strategy (GLS-based cardiotoxicity monitoring and administration of candesartan) by comparing with conventional intervention strategy (left ventricular ejection fraction-based cardiotoxicity monitoring and administration of candesartan) in breast cancer patients who treated with adjuvant trastuzumab.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Conventional Cardiac intervention | Active Comparator | Starting candesartan in patients with left ventricular ejection fraction (LVEF) between 45% and 50% by echocardiogram. |
|
| Early Cardiac intervention | Active Comparator | Starting candesartan in patients with decreased myocardial strain below 18% regardless of LVEF by echocardiogram. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Candesartan | Drug | If GLS decreased less than 18% or LVEF decreased to 45-50% during the treatment of adjuvant trastuzumab, start candesartan medication. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Left ventricular ejection fraction (LVEF) | Maximum change in LVEF | at months 3,6,9,12,18 |
| Measure | Description | Time Frame |
|---|---|---|
| Overt chemotherapy induced cardiotoxicity | LVEF < 45%, decline in LVEF by >10% to a value to 45-49%, symptomatic congestive heart failure | any time |
| Changes in cardiac biomarker | NT-pro BNP, cardiac troponin |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yeon Hee Park, MD, PhD | Contact | +82-2-3410-3450 | yeonh.park@samsung.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Samsung Medical Center | Recruiting | Seoul | 06351 | South Korea |
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| ID | Term |
|---|---|
| D066126 | Cardiotoxicity |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D006331 | Heart Diseases |
| D002318 | Cardiovascular Diseases |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| ID | Term |
|---|---|
| C081643 | candesartan |
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| at months 3,6,9,12,18 |
| D064420 | Drug-Related Side Effects and Adverse Reactions |
| D064419 | Chemically-Induced Disorders |
| D011832 | Radiation Injuries |
| D014947 | Wounds and Injuries |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |