PRADA
PRevention of cArdiac Dysfunction during Adjuvant breast cancer therapy
Patient / Population Intervention / Exposition Vergleich Endpunkt
In 130 women with early breast cancer receiving adjuvant anthracycline-based chemotherapy, concomitant candesartan attenuated the early decline in left ventricular ejection fraction on cardiac MRI, whereas metoprolol did not, compared with placebo.
N
130
Design
2×2 factorial, double-blind, placebo-controlled RCT
Endpunkt
Change in left ventricular ejection fraction on cardiac magnetic resonance imaging
Relevanz
3
ErgebnisLVEF decline 2.6 percentage points (95 % CI 1.5–3.8) with placebo vs 0.8 (95 % CI −0.4–1.9) with candesartan (p=0.026); no effect of metoprolol.
Gulati G, Heck SL, Ree AH, et al. Eur Heart J. 2016;37(21):1671-1680. 10.1093/eurheartj/ehw022
Diskussion & Kritik
Small and low-risk, with a surrogate imaging endpoint and an effect size below the 5-point threshold the investigators themselves called clinically important; the benefit did not persist in extended follow-up. It remains the reference trial for renin-angiotensin blockade during anthracycline therapy.