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Prevention study for Heart Failure
Official title Use of Dapagliflozin in Primary Prevention of Cardiotoxicity of Anthracycline Chemotherapy in Breast Cancer Patients
ClinicalTrials.gov ID: NCT07245069
What this study is testing
What is Dapagliflozin 10 mg?
Dapagliflozin 10 mg is an investigational medicine, given as an once-daily, being studied as a potential treatment for heart failure.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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?
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance. You may not know which one you got.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Adults ≥18 years.
- Histologically confirmed breast cancer with planned (neo)adjuvant anthracycline-based chemotherapy (4 cycles of epirubicin + cyclophosphamide or...
- 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.
You likely can't join if
- 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.
See the full eligibility 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Ljubljana, Slovenia
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Ljubljana, Slovenia. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.