The purpose of this study is to evaluate the effect of dapagliflozin on the incidence of cancer therapeutics-related cardiac dysfunction in patients with breast cancer receiving anthracycline treatment.
Age > 18 years and < 80 years.
Diagnosis of invasive breast cancer [stage I-III] and planned anthracycline treatment within 60 days.
Signed Informed Consent to participate in the study.
Urinary tract infection with the need for treatment with an antibiotic 48 hours before the scheduled start of anthracycline treatment.
Recognised heart failure or symptoms which, in the opinion of the investigator may be a symptom of undiagnosed heart failure.
Left ventricular ejection fraction < 50% at the time of the screening.
Severe valvular heart disease.
Parallel
Dapagliflozin
Drug10 mg tablet q.d
Placebo
Drugtablet matching dapagliflozin 10 mg q.d
Primary efficacy composite endpoint (cancer therapeutics related cardiac dysfunction) at 12 months.
Incidence of cancer therapeutics related cardiac dysfunction defined as: 1. the appearance of heart failure symptoms (NYHA class I-IV) due to an impairment of heart function or structure within 12 months; or 2. asymptomatic decrease in left ventricular ejection fraction \> 10% after 12 months; or 3. asymptomatic decrease in left ventricular ejection fraction \< 10% but up to 40-49% after 12 months; or 4. asymptomatic decrease in global left ventricular longitudinal strain \>15% after 12 months; or 5. asymptomatic increase in biomarkers (troponin I \> upper reference limit (99th centile) and increase of at least 30% from pre-treatment concentration or NTproBNP \> 125 pg/ml and increase of at least 30% from baseline) after 12 months.
Secondary efficacy composite endpoint (cancer therapeutics related cardiac dysfunction) at 6 months.
Incidence of cancer therapeutics related cardiac dysfunction defined as: 1. emergence of heart failure symptoms (NYHA class I-IV) due to impaired cardiac function or structure at 6 months; or 2. decrease LVEF \> 10% after 6 months; or 3. decrease LVEF \< 10% but to a value of 40-49% after 6 months; or 4. a decrease in global longitudinal strain of \> 15% after 6 months; or 5. asymptomatic increase in biomarkers (troponin I \> upper reference limit (99th centile) and an increase of at least 30% from pre-treatment concentration or NTproBNP \>125pg/ml and an increase of at least 30% from baseline) after 6 months.
Change in left ventricular ejection fraction at 6 and 12 months.
Assessed by transthoracic echocardiography.
Change in left ventricular diastolic function at 6 and 12 months.
Assessed as the ratio of E/E', i.e. maximum mitral annular inflow velocity during the rapid ventricular filling phase, to maximum mitral annular motion velocity by tissue Doppler during the rapid ventricular filling phase.
Change in Troponin I after 6 and 12 months.
Secondary.
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