Lewis Gregory D, Semigran Marc J, Givertz Michael M, Malhotra Rajeev, Anstrom Kevin J, Hernandez Adrian F, Shah Monica R, Braunwald Eugene
From the Cardiology Division, Massachusetts General Hospital, Harvard Medical School, Boston (G.D.L., M.J.S., R.M.); Cardiovascular Division, Brigham and Women's Hospital, Harvard Medical School, Boston, MA (M.M.G.); Duke Clinical Research Institute, Durham, NC (K.J.A., A.F.H.); Division of Cardiovascular Sciences, National Heart, Lung and Blood Institute, Bethesda, MD (M.R.S.); and Harvard Medical School, Boston, MA (E.B.).
Circ Heart Fail. 2016 May;9(5). doi: 10.1161/CIRCHEARTFAILURE.115.000345.
: Iron deficiency is present in ≈50% of patients with heart failure and is an independent predictor of mortality. Despite growing recognition of the functional and prognostic significance of iron deficiency, randomized multicenter trials exploring the use of oral iron supplementation in heart failure, a therapy that is inexpensive, readily available, and safe, have not been performed. Moreover, patient characteristics that influence responsiveness to oral iron in patients with heart failure have not been defined. Although results of intravenous iron repletion trials have been promising, regularly treating patients with intravenous iron products is both expensive and poses logistical challenges for outpatients. Herein, we describe the rationale for the Oral Iron Repletion effects on Oxygen Uptake in Heart Failure (IRONOUT HF) trial. This National Institute of Health-sponsored trial will investigate oral iron polysaccharide compared with matching placebo with the primary end point of change in exercise capacity as measured by peak oxygen consumption at baseline and at 16 weeks.
URL: http://www.clinicaltrials.gov. Unique identifier: NCT02188784.
缺铁在约50%的心力衰竭患者中存在，并且是死亡率的独立预测因素。尽管对缺铁的功能和预后意义的认识不断增加，但尚未进行探索在心力衰竭中使用口服铁补充剂的随机多中心试验，口服铁补充剂是一种廉价、易于获得且安全的治疗方法。此外，尚未明确影响心力衰竭患者对口服铁反应性的患者特征。虽然静脉补铁试验的结果很有前景，但定期用静脉铁产品治疗患者既昂贵，又给门诊患者带来后勤方面的挑战。在此，我们描述心力衰竭口服铁补充对摄氧量影响（IRONOUT HF）试验的基本原理。这项由美国国立卫生研究院资助的试验将研究口服铁多糖与匹配的安慰剂相比，以基线和16周时通过峰值耗氧量测量的运动能力变化作为主要终点。
