TOPCAT
Treatment of Preserved Cardiac Function Heart Failure with an Aldosterone Antagonist
Patient / Population Intervention / Exposition Vergleich Endpunkt
In 3,445 patients with HFpEF (EF ≥ 45%), spironolactone did not significantly reduce cardiovascular death, aborted cardiac arrest, or heart-failure hospitalisation compared with placebo.
N
3.445
Design
Double-blind placebo-controlled RCT
Endpunkt
Composite of cardiovascular death, aborted cardiac arrest, or heart-failure hospitalisation
Relevanz
2
ErgebnisNeutral: 18.6% with spironolactone vs 20.4% with placebo (HR 0.89, 95% CI 0.77-1.04; P=0.14). HF hospitalisation alone reduced (HR 0.83, 95% CI 0.69-0.99).
Pitt B, et al. N Engl J Med. 2014;370(15):1383-1392. 10.1056/NEJMoa1313731
Diskussion & Kritik
Marked regional heterogeneity (very low event rates and doubtful drug exposure in Russia/Georgia) undermined the null result; post-hoc Americas data suggest benefit. Guidelines give spironolactone a weak/conditional recommendation in HFpEF.