British Heart Foundation Cardiovascular Research Centre, University of Glasgow, Glasgow, UK.
Eur J Heart Fail. 2009 Aug;11(8):795-801. doi: 10.1093/eurjhf/hfp098.
Patients with heart failure (HF) and anaemia have greater functional impairment, worse symptoms, increased rates of hospital admission, and a higher risk of death, compared with non-anaemic HF patients. Whether correcting anaemia can improve outcomes is unknown.
The Reduction of Events with Darbepoetin alfa in Heart Failure trial (RED-HF; Clinical Trials.gov NCT 003 58215) was designed to evaluate the effect of the long-acting erythropoietin-stimulating agent darbepoetin alfa on mortality and morbidity (and quality of life) in patients with HF and anaemia.
Approximately 2600 patients with New York Heart Association class II-IV, an ejection fraction < or =40%, and a haemoglobin (Hb) consistently < or =12.0 g/dL but > or =9.0 g/dL will be enrolled. Patients are randomized 1:1 to double-blind subcutaneous administration of darbepoetin alfa or placebo. Investigators are also blinded to Hb measurements and darbepoetin alfa is dosed to achieve an Hb concentration of 13.0 g/dL (but not exceeding 14.5 g/dL) with sham adjustments of the dose of placebo. The primary endpoint is the time to death from any cause or first hospital admission for worsening HF, whichever occurs first. The study will complete when approximately 1150 subjects experience a primary endpoint.
与非贫血性心衰患者相比，心衰（HF）合并贫血的患者其功能损害更大，症状更差，住院率更高，死亡风险也更高。纠正贫血是否能改善预后尚不清楚。
Darbepoetin alfa 降低心衰事件试验（RED-HF；ClinicalTrials.gov NCT 00358215）旨在评估长效促红细胞生成素刺激剂达贝泊汀治疗心衰和贫血患者的死亡率和发病率（以及生活质量）的效果。
大约 2600 例纽约心脏协会（NYHA）心功能分级 II-IV 级、射血分数 <或=40%、且血红蛋白（Hb）持续 <或=12.0g/dL 但 >或=9.0g/dL 的患者将被纳入。患者将以 1:1 的比例随机接受达贝泊汀或安慰剂的皮下双盲治疗。研究者也对 Hb 测量值进行盲法处理，并且达贝泊汀的剂量设定为使 Hb 浓度达到 13.0g/dL（但不超过 14.5g/dL），安慰剂的剂量则进行模拟调整。主要终点是任何原因导致的死亡时间或首次因心衰恶化而住院的时间，以先发生者为准。当大约 1150 名患者出现主要终点时，研究将完成。
