RecruitingPhase 3NCT06711185
Effect of DAPAglifozin on MYOcardial Remodeling of Breast CANCER Patients Treated with Anthracycline Based Chemotherapy
Sponsor
University of Campinas, Brazil
Enrollment
80 participants
Start Date
Jan 30, 2024
Study Type
INTERVENTIONAL
Conditions
Summary
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.
Eligibility
Sex: FEMALEMin Age: 18 Years
Inclusion Criteria4
- Female
- Over 18 years old
- Breast cancer
- Chemotherapy as treatment planning and programmed cumulative dose equivalent to 240 mg/m2 of doxorubicin.
Exclusion Criteria6
- 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.
- Previous history of significant valvular heart disease.
- Previous history of cardiomyopathies.
Interventions
DRUGDapagliflozin 10 mg
Patients in this group will receive 1 tablet of 10mg dapagliflozin daily for 9 months, starting 7-10 days before chemotherapy treatment.
OTHERPlacebo
Patients 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
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06711185
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