6/29/23, 1:09 AM RED-HF Pathway Feedback Search Clinical Topics Home Studies RED HF RED HF Disease Heart failure Trial question What is the role of darbepoetin alfa in patients with systolic HF and mild-to-moderate anemia? Study design Multi-center Double blinded RCT Population Characteristics of study participants 41.0% female N = 2278 59.0% male 2278 patients (944 female, 1334 male) Inclusion criteria: patients with systolic HF and mild-to-moderate anemia Key exclusion criteria: transferrin saturation < 15%, bleeding or other correctable causes of anemia, serum creatinine level > 3 mg/dL, and a BP > 160/100 mmHg Interventions N=1136 darbepoetin alfa (subcutaneous starting dose of 0.75 g/kg of body weight once every 2 weeks once Hgb level of 13.0 g/dL achieved) N=1142 placebo (matching dose adjustments) Primary outcome Death from any cause or hospitalization for worsening heart failure https://web.pathway.md/studies/rechWH6MjiwTLqvuE 1/2 6/29/23, 1:09 AM RED-HF Pathway 50.7 % 50.7 49.5 38.0 % 25.4 % 12.7 % No significant difference 0.0 % Darbepoetin alfa Placebo No significant difference in death from any cause or hospitalization for worsening HF (50.7% vs. 49.5%; HR 1.01, 95% CI 0.9 to 1.13) Secondary outcomes No significant difference in fatal or nonfatal stroke (3.7% vs. 2.7%; HR 1.33, 95% CI 0.83 to 2.12) No significant difference in death (41.7% vs. 40.1%; HR 1.04, 95% CI 0.92 to 1.19) Safety outcomes No significant difference in cancer-related adverse events. Significant differences in thromboembolic adverse events (13.5% vs. 10.0%, p = 0.01). Conclusion In patients with systolic HF and mild-to-moderate anemia, darbepoetin alfa was not superior to placebo with respect to death from any cause or hospitalization for worsening HF. Reference Swedberg K, Young JB, Anand IS et al. Treatment of anemia with darbepoetin alfa in systolic heart failure. N Engl J Med. 2013 Mar 28;368(13):1210-9. Open reference URL https://web.pathway.md/studies/rechWH6MjiwTLqvuE 2/2