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Use of Dapagliflozin in Primary Prevention of Cardiotoxicity of Anthracycline Chemotherapy in Breast Cancer Patients

RecruitingPhase 2Ages 18 Years - anyAllUniversity Medical Centre Ljubljana
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In plain words

What the trial is, and whether it could suit you

The goal of this randomized, double-blind, placebo-controlled clinical trial is to determine whether dapagliflozin, a sodium-glucose cotransporter-2 (SGLT-2) inhibitor, can help prevent anthracycline-induced cardiotoxicity caused by anthracycline chemotherapy in adult women with breast cancer receiving (neo)adjuvant treatment. The main questions the study aims to answer are: i) Does dapagliflozin reduce the decline in left ventricular function (measured by LVEF, GLS, and myocardial work) during and after anthracycline therapy? ii) Does dapagliflozin lessen the deteriorating effect of chemotherapy on endothelial function and arterial stiffness? iii) Does dapagliflozin effect levels of cardiac injury and inflammation biomarkers (e.g., hs-troponin T, NT-proBNP, ST-2, GDF-15, galectin-3, IL-6, MPO)? Researchers will compare dapagliflozin 10 mg daily with placebo to see whether those recei

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Adults โ‰ฅ18 years. * Histologically confirmed breast cancer with planned (neo)adjuvant anthracycline-based chemotherapy (4 cycles of epirubicin + cyclophosphamide or doxorubicin + cyclophosphamide). * Eligible to start dapagliflozin or placebo prior to or at initiation of chemotherapy. * Able to perform baseline echocardiography, vascular ultrasound (FMD and carotid stiffness), 6-minute walk test, and biomarker sampling. * Willing and able to provide written informed consent. Exclusion Criteria: * Known heart failure (any prior diagnosis of HF). * Clinically significant valvular heart disease. * Prior exposure to chemotherapy or radiotherapy to the left chest. * Type 1 diabetes mellitus. * Symptomatic hypotension. * History of recurrent urinary tract infections. * History of diabetic ketoacidosis or ketonemia. * Severe hepatic impairment (ALT, AST, ALP \>3ร— upper limit of normal). * Severe renal impairment (eGFR \<20 mL/min/1.73 mยฒ). * Known allergy or intolerance to SGLT-2 inhibitors. * Any use of SGLT-2 inhibitor therapy within 3 months prior to enrollment. * Pregnancy or breastfeeding. * Any condition that, in the investigator's judgment, could interfere with study participation, safety, or completion.
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What it tests

  • Dapagliflozin 10 mg
  • Placebo
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Where

1 site
University Medical Centre Ljubljana
Ljubljana, Slovenia
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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