2D Speckle-tracking Echocardiography in Chemotherapy-induced Cardiomyopathy With Cardiovascular Risk Factors

• Conditions: Cardiovascular Risk Factor; Cardiomyopathy Due to Drug; Breast Cancer

• Registration Number: NCT04547465
• Lead Sponsor: Gia Dinh People Hospital

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

Study Timeline

• Study First Submitted: 2020-09-06
• Study First Submitted QC: 2020-09-06
• Study First Posted: 2020-09-14
• Study Start: 2020-09-15
• Status Verified: 2022-08
• Last Update Submitted: 2023-08-04
• Last Update Posted: 2023-08-08
• Primary Completion: 2023-10-30
• Study Completion: 2023-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 300

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The kinetics of right ventricular longitudinal strain (RV-GLS and RV-FWLS) in breast cancer patients treated by anthracycline and/or trastuzumab	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	two year follow-up	global longitudinal strain (percentage)
The incidence of chemotherapy induced cardiomyopathy in breast cancer patients with cardiovascular risk	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	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	two year follow-up	longitudinal strain (percentage)

Trial Locations

Locations (1)

Nguyen Hoang Hai; 🇻🇳 Ho Chi Minh, Vietnam