Clinical trial NCT04547465: 2D Speckle-tracking Echocardiography in Chemotherapy-induced Cardiomyopathy With Cardiovascular Risk Factors
Official title: The Role of 2D Speckle-tracking Echocardiography in Diagnosis Chemotherapy-induced Cardiomyopathy in Breast Cancer Patients With High Cardiovascular Risk Factors
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Cardiomyopathy Due to Drug
Breast Cancer
Cardiovascular Risk Factor
Lead sponsor: Gia Dinh People Hospital
Sponsor class: OTHER
First posted: 2020-09-14
Enrollment: 300
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Breast cancer patients treated by anthracycline and/or trastuzumab with at least one of the cardiovascular risk factors

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

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

Primary outcomes:
measure: The incidence of chemotherapy induced cardiomyopathy in breast cancer patients with cardiovascular risk
timeFrame: two year follow-up
measure: The kinetics of left ventricular global longitudinal strain (LV-GLS) in breast cancer patients treated by anthracycline and/or trastuzumab
timeFrame: two year follow-up
measure: The cut-off value of global longitudinal strain (GLS) to predict chemotherapy induced cardiomyopathy in breast cancer patients treated by anthracycline and/or trastuzumab
timeFrame: two year follow-up
measure: The kinetics of right ventricular longitudinal strain (RV-GLS and RV-FWLS) in breast cancer patients treated by anthracycline and/or trastuzumab
timeFrame: two year follow-up
measure: The kinetics of left atrial longitudinal strain (LASr, LAScd, LASct) in breast cancer patients treated by anthracycline and/or trastuzumab
timeFrame: two year follow-up
Secondary outcomes:
Other outcomes:
Locations:
city: Ho Chi Minh
country: Vietnam
facility: Nguyen Hoang Hai
Study officials:
affiliation: Cardiology Department
name: Hai H. Nguyen, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: