NCT07245069 Use of Dapagliflozin in Primary Prevention of Cardiotoxicity of Anthracycline Chemotherapy in Breast Cancer Patients
| NCT ID | NCT07245069 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | University Medical Centre Ljubljana |
| Condition | Heart Failure |
| Study Type | INTERVENTIONAL |
| Enrollment | 100 participants |
| Start Date | 2025-02-01 |
| Primary Completion | 2028-11 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 100 participants in total. It began in 2025-02-01 with a primary completion date of 2028-11.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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 receiving dapagliflozin experience less heart and vascular impairment during treatment. Participants will: * Take either dapagliflozin or placebo once daily during anthracycline chemotherapy. * Undergo heart and vascular ultrasound, and a 6-minute walk test before chemotherapy and again at 24 and 52 weeks. * Provide blood samples before, during and after chemotherapy to measure cardiac biomarkers. * Complete multiple questionnaires on quality of life.
Eligibility Criteria
Inclusion Criteria: * Adults ≥18 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 \>3× upper limit of normal). * Severe renal impairment (eGFR \<20 mL/min/1.73 m²). * 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.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07245069 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying Heart Failure. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07245069 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07245069 currently recruiting?
Yes, NCT07245069 is actively recruiting participants. Contact the research team at jure.trsan@gmail.com for enrollment information.
Where is the NCT07245069 trial being conducted?
This trial is being conducted at Ljubljana, Slovenia.
Who is sponsoring the NCT07245069 clinical trial?
NCT07245069 is sponsored by University Medical Centre Ljubljana. The trial plans to enroll 100 participants.
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