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

NCT07245069 Phase 2 RECRUITING

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.

Details

Lead sponsor	University Medical Centre Ljubljana
Phase	Phase 2
Status	RECRUITING
Enrolment	100
Start date	2025-02-01
Completion	2029-02

Conditions

• Heart Failure
• Anthracycline-induced Cardiac Toxicity
• Endothelial Function (FMD)
• Arterial Stiffness
• Breast Cancer

Interventions

• Dapagliflozin 10 mg
• Placebo

Primary outcomes

• Change in Global Longitudinal Strain (GLS) — 52 weeks
  Global Longitudinal Strain (GLS), measured using speckle-tracking echocardiography in three apical views, will be used to quantify subclinical left ventricular systolic dysfunction. The primary endpoint is the change in GLS from baseline to 24 and 52 weeks. A relative worsening of \>15% is considered clinically meaningful.
• Change in Flow-Mediated Dilation (FMD) of the Brachial Artery — 52 weeks
  Endothelial function will be assessed by ultrasound measurement of flow-mediated dilation (FMD) of the brachial artery after forearm cuff occlusion. The endpoint is the absolute change in FMD (%) from baseline to 24 weeks. A reduction \>2 absolute percentage points will be considered clinically meaningful. FMD will also be measured at 52 weeks to characterize the sustained effect of dapagliflozin on endothelial function compared with placebo.

Countries

Slovenia