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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04547465
• Other study ID #: 230/HÐÐÐ-ÐHYD
• Status: Recruiting
• Start date: September 15, 2020
• Est. completion date: December 30, 2023

Study information

• Verified date: August 2022
• Source: Gia Dinh People Hospital
• Contact: Nhat M. Giang, M.D
• Phone: +84919963999
• Email: minhnhat210189[@]gmail.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 300
• Est. completion date: December 30, 2023
• Est. primary completion date: October 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms
• Cardiomyopathies
• Cardiomyopathy Due to Drug
• Cardiovascular Risk Factor

Intervention

Diagnostic Test:
• Echocardiography
2D Speckle-tracking echocardiography

Locations

Country	Name	City	State
Vietnam	Nguyen Hoang Hai	Ho Chi Minh

Sponsors (1)

Lead Sponsor	Collaborator
Gia Dinh People Hospital

Country where clinical trial is conducted

Vietnam, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The incidence of chemotherapy induced cardiomyopathy in breast cancer patients with cardiovascular risk	the incidence	two year follow-up
Primary	The kinetics of left ventricular global longitudinal strain (LV-GLS) in breast cancer patients treated by anthracycline and/or trastuzumab	global longitudinal strain (percentage)	two year follow-up
Primary	The cut-off value of global longitudinal strain (GLS) to predict chemotherapy induced cardiomyopathy in breast cancer patients treated by anthracycline and/or trastuzumab	global longitudinal strain (percentage)	two year follow-up
Primary	The kinetics of right ventricular longitudinal strain (RV-GLS and RV-FWLS) in breast cancer patients treated by anthracycline and/or trastuzumab	longitudinal strain (percentage)	two year follow-up
Primary	The kinetics of left atrial longitudinal strain (LASr, LAScd, LASct) in breast cancer patients treated by anthracycline and/or trastuzumab	longitudinal strain (percentage)	two year follow-up