Efficacy of empagliflozin in prevention of Doxorubicin-induced cardiotoxicity in patients with breast cancer

Phase 3

Recruiting

• Conditions: Condition 1: Breast cancer. Condition 2: Drug-induced cardiomyopathy.; I42.7; Malignant neoplasm of breast; Cardiomyopathy due to drug and external agent

• Registration Number: IRCT20231014059713N1
• Lead Sponsor: Tehran University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 22 January 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: Female
• Target Recruitment: 64

Inclusion Criteria

A known case of breast cancer and candidate for receiving AC regimen
Signing a written informed consent to participate in the study
Patient age = 18
Ability to take oral medicine
ECOG performance status less than or equal to 2

Exclusion Criteria

A history of breast cancer or a history of receiving chemotherapy regimen containing anthracycline or other chemotherapy drugs causing cardiomyopathy before entering the study
Inability to assess left ventricular (LV) function
Previous history of chest radiation therapy
Evidence of heart failure or left ventricular dysfunction based on echocardiography
Diagnosis or history of cardiomyopathies
Significant coronary artery disease (history of coronary stenting or stenosis based on previous angiography, history of known IHD or MI)
Severe valvular heart disease
Cardiac arrhythmia such as atrial fibrillation
Symptomatic hypotension or blood pressure less than 90 mmHg at the first visit
Liver enzymes more than 3 times ULN before entering the study
Significant renal failure (GFR less than 20 ml/min/1.73m2 with CKD-EPI formula) or need for dialysis
Simultaneous use of other drugs that can affect parameters of the study (such as ACEi, ARB, beta blockers)
Diabetes
Pregnancy
Breastfeeding
Hypersensitivity to SGLT2 inhibitor drugs
History of treatment with SGLT2 inhibitors during the last 3 months before the start of the study
Participation in other clinical studies simultaneously

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
VEF (Left ventricular ejection fraction) : The left ventricular drain fraction or the amount of blood pumped from the left ventricle with each contraction. Timepoint: Once at the beginning and once a week after the last chemotherapy session. Method of measurement: Using echocardiography performed by a cardiologist.;GLS (Global longitudinal strain): A sensitive criterion used by echocardiography to measure myocardial deformity and left ventricular contractile strength and can aid in the early diagnosis of cardiotoxicity. A decrease of more than 15% compared to the beginning or an absolute value of -19% after the start of anthracyclines is associated with a significant increase in the risk of future LVEF reduction. Timepoint: At the beginning and one week after the last chemotherapy session. Method of measurement: Echocardiography by a cardiologist.