Prospective, randomized, double-blind, controlled clinical trial to compare the effect of 9 months of treatment with dapagliflozin vs. placebo on anthracycline-induced cardiotoxicity in patients with breast cancer.
Female
Over 18 years old
Breast cancer
Chemotherapy as treatment planning and programmed cumulative dose equivalent to 240 mg/m2 of doxorubicin.
Contraindications for performing CMR exams, such as patients with pacemakers or cardiac defibrillators of any type, metal clips for cerebral aneurysms, cochlear implants, and ventriculoperitoneal bypass valves.
Inability to perform CMR due to claustrophobia.
Renal failure with a glomerular filtration rate < 30 ml/min/1.73 m2.
Previous history of myocardial infarction, congestive heart failure, or myocardial revascularization, whether percutaneous or surgical.
Parallel
Dapagliflozin 10 mg
DrugPatients in this group will receive 1 tablet of 10mg dapagliflozin daily for 9 months, starting 7-10 days before chemotherapy treatment.
Placebo
Other interventionPatients in this group will receive 1 placebo tablet per day, with identical characteristics to the group receiving dapagliflozin, for 9 months, starting 7-10 days before the start of chemotherapy treatment
Change in left ventricle ejection fraction
The primary outcome will be the 6% difference in the mean of left ventricle ejection fraction change, as assessed by CMR, between the placebo group and the dapagliflozin group
Click on the lead sponsor to view all of their trials.
