6/30/23, 2:19 AM TOPCAT Pathway Feedback Search Clinical Topics Home Studies TOPCAT TOPCAT Disease Heart failure Trial question What is the effect of spironolactone in patients with HF and a preserved LVEF? Study design Multi-center Double blinded RCT Population Characteristics of study participants 52.0% female N = 3445 48.0% male 3445 patients (1775 female, 1670 male) Inclusion criteria: patients with HF and a preserved LVEF Key exclusion criteria: severe systemic illness with a life expectancy of < 3 years, severe renal dysfunction, and specific coexisting conditions, medications, or acute events Interventions N=1722 spironolactone (15 to 45 mg daily) N=1723 placebo (matching placebo) Primary outcome Death from cardiovascular causes, aborted cardiac arrest, or hospitalization for heart failure 20.4 https://web.pathway.md/studies/reccOqPEnjny7ynTe 1/2 6/30/23, 2:19 AM TOPCAT Pathway 0 20.4 % 18.6 15.3 % 10.2 % 5.1 % No significant difference 0.0 % Spironolactone Placebo No significant difference in death from cardiovascular causes, aborted cardiac arrest, or hospitalization for HF (18.6% vs. 20.4%; HR 0.89, 95% CI 0.77 to 1.04) Secondary outcomes Significant decrease in hospitalization for HF (12% vs. 14.2%; HR 0.83, 95% CI 0.69 to 0.99) No significant difference in cardiovascular death (9.3% vs. 10.2%; HR 0.9, 95% CI 0.73 to 1.12) No significant difference in aborted cardiac arrest (0.2% vs. 0.3%; HR 0.6, 95% CI 0.14 to 2.5) Safety outcomes No significant differences in serious adverse events, serum creatinine level 3.0 mmg/dL, or dialysis. Significant difference in hyperkalemia (18.7% vs. 9.1%) and hypokalemia (16.2% vs. 22.9%). Conclusion In patients with HF and a preserved LVEF, spironolactone was not superior to placebo with respect to death from cardiovascular causes, aborted cardiac arrest, or hospitalization for HF. Reference Pitt B, Pfeffer MA, Assmann SF et al. Spironolactone for heart failure with preserved ejection fraction. N Engl J Med. 2014 Apr 10;370(15):1383-92. Open reference URL https://web.pathway.md/studies/reccOqPEnjny7ynTe 2/2