Institute of Cardiovascular and Medical Sciences, BHF Glasgow Cardiovascular Research Centre, University of Glasgow, Glasgow G12 8TA, UK.
Eur J Heart Fail. 2013 Mar;15(3):334-41. doi: 10.1093/eurjhf/hfs204. Epub 2013 Jan 17.
This report describes the baseline characteristics of patients in the Reduction of Events with Darbepoetin alfa in Heart Failure trial (RED-HF) which is testing the hypothesis that anaemia correction with darbepoetin alfa will reduce the composite endpoint of death from any cause or hospital admission for worsening heart failure, and improve other outcomes.
Key demographic, clinical, and laboratory findings, along with baseline treatment, are reported and compared with those of patients in other recent clinical trials in heart failure. Compared with other recent trials, RED-HF enrolled more elderly [mean age 70 (SD 11.4) years], female (41%), and black (9%) patients. RED-HF patients more often had diabetes (46%) and renal impairment (72% had an estimated glomerular filtration rate < 60 mL/min/1.73 m2). Patients in RED-HF had heart failure of longer duration [5.3 (5.4) years], worse NYHA class (35% II, 63% III, and 2% IV), and more signs of congestion. Mean EF was 30% (6.8%). RED-HF patients were well treated at randomization, and pharmacological therapy at baseline was broadly similar to that of other recent trials, taking account of study-specific inclusion/exclusion criteria. Median (interquartile range) haemoglobin at baseline was 112 (106-117) g/L.
The anaemic patients enrolled in RED-HF were older, moderately to markedly symptomatic, and had extensive co-morbidity.
本报告描述了心力衰竭中达贝泊汀 α 减少事件试验(RED-HF)患者的基线特征,该试验检验了这样一个假设,即达贝泊汀 α 纠正贫血将减少任何原因导致的死亡或因心力衰竭恶化而住院的复合终点,并改善其他结局。
报告了关键的人口统计学、临床和实验室发现,以及基线治疗情况,并与心力衰竭的其他近期临床试验中的患者进行了比较。与其他最近的试验相比,RED-HF 纳入了更多的老年患者[平均年龄 70(SD 11.4)岁]、女性(41%)和黑人(9%)。RED-HF 患者更常患有糖尿病(46%)和肾功能损害(72%的估计肾小球滤过率<60 mL/min/1.73 m2)。RED-HF 患者心力衰竭持续时间更长[5.3(5.4)年],NYHA 分级更差(35%为 II 级,63%为 III 级,2%为 IV 级),且充血迹象更多。平均 EF 为 30%(6.8%)。RED-HF 患者在随机分组时治疗良好,且基线时的药物治疗与其他最近的试验基本相似,考虑到研究特定的纳入/排除标准。基线时的中位(四分位间距)血红蛋白为 112(106-117)g/L。
RED-HF 纳入的贫血患者年龄较大,中度至重度有症状,且合并症广泛。