Condition 1: Breast cancer. Condition 2: Drug-induced cardiomyopathy. Malignant neoplasm of breast Cardiomyopathy due to drug and external agent
Conditions
Interventions
Intervention 1: Intervention group: A group in which patients receive Empagliflozin drug produced by abidi pharmaceutical at a dose of 10 mg once in the day along with chemotherapy. The patient will r
Sponsors
Tehran University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
18 Years to No maximum
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| LVEF (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. | — |
Secondary
| Measure | Time frame |
|---|---|
| Troponin I: One of the three types of troponin present in the body that is more specific to the myocardium of the heart and as a marker of the heart, can help diagnose myocardial damage. This enzyme increases within a few hours after heart damage and can last for a long time. Remain in my head for 10-14 days. Timepoint: Once at the beginning and twice at one week after the second and last session of chemotherapy. Method of measurement: Blood sampling and blood level measurement by laboratory.;NT-proBNP: It is one of the types of natriuretic peptides that indicates the filling pressure inside the heart and the stress of the walls of the ventricles, which is used to diagnose heart failure. Timepoint: Once at the beginning and twice at one week after the second and last session of chemotherapy. Method of measurement: Blood sampling and blood level measurement by laboratory. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactEhsan Shabani
Tehran University of Medical Sciences
Outcome results
None listed