随机研究铁羧基麦芽糖治疗心力衰竭伴缺铁患者的疗效和安全性的基线特征：HEART-FID 试验。
Baseline characteristics of patients in the randomized study to investigate the efficacy and safety of ferric carboxymaltose as treatment for heart failure with iron deficiency: HEART-FID trial.
机构信息
Department of Medicine, Division of Cardiology, Duke University, Durham, NC; Duke Clinical Research Institute, Durham, NC.
Department of Medicine, Division of Cardiology, Duke University, Durham, NC; Duke Clinical Research Institute, Durham, NC.
出版信息
Am Heart J. 2023 Dec;266:25-31. doi: 10.1016/j.ahj.2023.08.005. Epub 2023 Aug 19.
BACKGROUND
Prior clinical trials have investigated intravenous iron in patients with heart failure (HF) and iron deficiency, but the safety and efficacy of this therapy remains unclear.
METHODS
We report the baseline demographics and clinical characteristics of patients enrolled in the HEART-FID study and compare HEART-FID participants with patients within other contemporary clinical trials of patients with HF with reduced ejection fraction (HFrEF), including other intravenous iron trials.
RESULTS
In the 3,065 participants randomized in HEART-FID, median (IQR) age was 69.7 (62.0-76.5) years, 1,037 (33.8%) were female, 322 (10.5%) were Black, median ejection fraction was 32% (25%-37%), 1,837 (60.0%) had ischemic etiology, and baseline median NT-proBNP was 1,462 (721-2,966) pg/mL. Median baseline hemoglobin was 12.6 (11.6-13.6) g/dL, and median 6-minute walk test distance was 272 (196-350) m, similar to prior intravenous iron HFrEF trials. Common comorbidities included atrial fibrillation/flutter (43.7%), and type 2 diabetes (45.2%). Compared with several recent HFrEF trials, patients enrolled in HEART-FID had similar baseline demographics and clinical characteristics, though a greater proportion of women and Black participants were recruited in HEART-FID. In HEART-FID, HFrEF therapy included a beta-blocker in 92.5%, angiotensin-converting enzyme inhibitor/angiotensin receptor blocker/angiotensin receptor-neprilysin inhibitors (ARNI) in 86.1% (with 29.7% ARNI), and a mineralocorticoid antagonist (MRA) in 55.6%.
CONCLUSIONS
Patients enrolled in HEART-FID were similar to those enrolled in other contemporary HFrEF trials and registries, including trials of intravenous iron in HFrEF. However, the HEART-FID cohort is substantially larger and more racially diverse than prior trials of intravenous iron in HFrEF.
TRIAL REGISTRATION
ClinicalTrials.gov (NCT03037931).
背景
先前的临床试验已经研究了静脉铁在心力衰竭（HF）和缺铁患者中的应用，但这种治疗的安全性和疗效仍不清楚。
方法
我们报告了 HEART-FID 研究中入组患者的基线人口统计学和临床特征，并将 HEART-FID 参与者与其他射血分数降低的心力衰竭（HFrEF）的当代临床试验（包括其他静脉铁试验）中的患者进行了比较。
结果
在 HEART-FID 中随机分配的 3065 名参与者中，中位（IQR）年龄为 69.7（62.0-76.5）岁，1037 名（33.8%）为女性，322 名（10.5%）为黑人，中位射血分数为 32%（25%-37%），1837 名（60.0%）为缺血性病因，基线中位 NT-proBNP 为 1462（721-2966）pg/mL。中位基线血红蛋白为 12.6（11.6-13.6）g/dL，6 分钟步行试验距离为 272（196-350）m，与先前的静脉铁 HFrEF 试验相似。常见的合并症包括心房颤动/扑动（43.7%）和 2 型糖尿病（45.2%）。与几项最近的 HFrEF 试验相比，入组 HEART-FID 的患者具有相似的基线人口统计学和临床特征，但女性和黑人参与者的比例在 HEART-FID 中更高。在 HEART-FID 中，HFrEF 治疗包括 92.5%的β受体阻滞剂、86.1%的血管紧张素转换酶抑制剂/血管紧张素受体阻滞剂/血管紧张素受体脑啡肽酶抑制剂（ARNI）（其中 29.7%为 ARNI）和 55.6%的盐皮质激素受体拮抗剂（MRA）。
结论
入组 HEART-FID 的患者与其他当代 HFrEF 试验和登记处的患者相似，包括 HFrEF 中的静脉铁试验。然而，与之前的 HFrEF 静脉铁试验相比，HEART-FID 队列的规模更大，种族多样性更高。
试验注册
ClinicalTrials.gov（NCT03037931）。
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