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Clinical Trials/NCT04547465
NCT04547465
Unknown
Not Applicable

The Role of 2D Speckle-tracking Echocardiography in Diagnosis Chemotherapy-induced Cardiomyopathy in Breast Cancer Patients With High Cardiovascular Risk Factors

Gia Dinh People Hospital1 site in 1 country300 target enrollmentSeptember 15, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Cardiomyopathy Due to Drug
Sponsor
Gia Dinh People Hospital
Enrollment
300
Locations
1
Primary Endpoint
The kinetics of right ventricular longitudinal strain (RV-GLS and RV-FWLS) in breast cancer patients treated by anthracycline and/or trastuzumab
Last Updated
2 years ago

Overview

Brief Summary

The aims of this study is to evaluate the role of 2D speckle-tracking echocardiography in diagnosis chemotherapy related left ventricular dysfunction in breast cancer patients with cardiovascular risks

Detailed Description

Chemotherapy induced cardiomyopathy is a serious adverse effect of anticancer treatments with poor long-term prognosis. In addition to the cumulative dose of anthracycline and trastuzumab, cardiovascular risks have been proven to be the "second hit" when dealing with chemotherapy related cardiomyopathy in breast cancer patients. Speckle-tracking echocardiography have had robust evidence in diagnosis the early stage of left ventricular dysfunction in various types of cancer treated by cardiotoxicity drugs. However, data is still lacking regarding the role of speckle-tracking echocardiography in breast cancer patients with cardiovascular risk

Registry
clinicaltrials.gov
Start Date
September 15, 2020
End Date
December 30, 2023
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Gia Dinh People Hospital
Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Breast cancer patients treated by anthracycline and/or trastuzumab
  • Have at least one of these cardiovascular risks: age \> 60, hypertension, atrial fibrillation, diabetes mellitus, dyslipidemia, chronic kidney disease, obesity, family history of cardiovascular diseases.

Exclusion Criteria

  • Left ventricular ejection fraction \< 50% before chemotherapy
  • Chronic heart failure with NYHA functional class \>= II
  • Significant valvular stenosis/regurgitation
  • Acute heart failure due to acute coronary syndrome during follow-up

Outcomes

Primary Outcomes

The kinetics of right ventricular longitudinal strain (RV-GLS and RV-FWLS) in breast cancer patients treated by anthracycline and/or trastuzumab

Time Frame: two year follow-up

longitudinal strain (percentage)

The kinetics of left ventricular global longitudinal strain (LV-GLS) in breast cancer patients treated by anthracycline and/or trastuzumab

Time Frame: two year follow-up

global longitudinal strain (percentage)

The incidence of chemotherapy induced cardiomyopathy in breast cancer patients with cardiovascular risk

Time Frame: two year follow-up

the incidence

The cut-off value of global longitudinal strain (GLS) to predict chemotherapy induced cardiomyopathy in breast cancer patients treated by anthracycline and/or trastuzumab

Time Frame: two year follow-up

global longitudinal strain (percentage)

The kinetics of left atrial longitudinal strain (LASr, LAScd, LASct) in breast cancer patients treated by anthracycline and/or trastuzumab

Time Frame: two year follow-up

longitudinal strain (percentage)

Study Sites (1)

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