Women treated for breast cancer are at increased risk for cardiovascular disease, including heart failure. In this study, by using magnetic resonance imaging (MRI), the investigators want to assess if heart failure medications such as beta blockers and angiotensin receptor blockers can prevent cardiac dysfunction during early breast cancer therapy.
Breast cancer is one of the most common malignancies in women. Recent progress in the detection and treatment of breast cancer has resulted in survival gains, but a consequence of therapeutic advances is an increasing number of long-term survivors who may be at risk for development of cardiovascular disease. Several studies suggest that women treated for breast cancer may be at increased risk for cardiovascular disease, the probable causes being multi-factorial. Importantly, therapies for breast cancer, including radiotherapy, anti-HER-2 regimens and certain chemotherapeutic regimens, may increase the risk of subsequent cardiovascular disease, including atherosclerotic disease, left ventricular dysfunction, and heart failure. In the current study we propose to undertake a randomized, placebo-controlled, 2x2 factorial, double-blind trial to assess whether left ventricular dysfunction and/or injury is preventable, completely or partly, by the concomitant administration of the angiotensin receptor blocker (ARB), candesartan, and the beta blocker, metoprolol, during postoperative chemotherapy and radiotherapy. The proposed study addresses an important clinical problem in a large patient group. Thus, the possibility of preventing cardiovascular side effects of contemporary therapy for breast cancer is important both clinically and scientifically.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Enrollment
130
Tablet, target dose 100 mg once daily
Tablet, target dose 100 mg once daily
Tablet, target dose 32 mg once daily
Akershus University Hospital
Lørenskog, Norway
Change in left ventricular ejection fraction, as assessed by cardiac MRI
Time frame: Baseline and end of study (up to 72 weeks)
Change in contrast enhancement by MRI
Time frame: Baseline and approximately 4 weeks
Change in left 2D global strain, as assessed by echocardiography
Time frame: Baseline and end of study (up to 72 weeks)
Incidence of clinical of heart failure or objective left ventricular dysfunction
Left ventricular dysfunction defined as ejection fraction \< 55% by cardiac MRI
Time frame: Up to 72 weeks
Change in biochemical markers of cardiac injury, i.e. hs-cTnT
Time frame: Baseline and end of study (up to 72 weeks)
Change in left ventricular diastolic function, as assessed by echocardiography
Diastolic function assessed by e/e'
Time frame: Baseline and end of study (up to 72 weeks)
Change in biochemical markers of cardiac function, i.e. NT-proBNP
Time frame: Baseline and end of study (up to 72 weeks)
Change in contrast enhancement, as assessed by cardiac MRI
Time frame: Baseline and end of study (up to 72 weeks)
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Tablet, 32 mg once daily