Faculty of Medicine, Institute for Clinical Medicine, University of Oslo, Oslo, Norway.
Faculty of Medicine, Institute for Clinical Medicine, University of Oslo, Oslo, Norway
BMJ Open. 2022 Sep 2;12(9):e059546. doi: 10.1136/bmjopen-2021-059546.
Iron deficiency is a prevalent comorbidity in patients with severe aortic stenosis and may be associated with procedural and clinical outcomes after transcatheter aortic valve implantation (TAVI). In the ntravenous ron Supplement for ron Deficiency in Patients with evere ortic tenosis (IIISAS) trial, we aim to examine whether a single administration of ferric derisomaltose can improve physical capacity after TAVI.
This randomised, double-blind, placebo-controlled trial aims to enrol 150 patients with iron deficiency who are scheduled for TAVI due to severe aortic stenosis. The study drug and matching placebo are administered approximately 3 months prior to TAVI, and the patients are followed for 3 months after TAVI. Inclusion criteria are iron deficiency, defined as serum ferritin<100 µg/L or ferritin between 100 and 300 µg/L in combination with a transferrin saturation<20% and written informed consent. Exclusion criteria include haemoglobin<10 g/dL, red blood cell disorders, end-stage kidney failure, intolerance to ferric derisomaltose, and ongoing infections. The primary endpoint is the baseline-adjusted distance walked on a 6 min walk test (6MWT) 3 months after TAVI. Secondary end points include quality of life, New York Heart Association functional class (NYHA functional class), and skeletal muscle strength.
Ethical approval was obtained from the Regional Committee for Medical and Health Research of South-Eastern Norway and The Norwegian Medicines Agency. Enrolment has begun, and results are expected in 2022. The results of the IIISAS trial will be disseminated by presentations at international and national conferences and by publications in peer-reviewed journals.
NCT04206228.
缺铁是严重主动脉瓣狭窄患者常见的合并症，可能与经导管主动脉瓣植入术（TAVI）后的程序和临床结局相关。在静脉注射铁剂治疗严重主动脉瓣狭窄患者缺铁的研究（IIISAS）中，我们旨在研究单次给予铁右旋糖酐是否可以改善 TAVI 后的体力。
这是一项随机、双盲、安慰剂对照试验，旨在招募 150 名因严重主动脉瓣狭窄而计划接受 TAVI 的缺铁患者。研究药物和匹配的安慰剂大约在 TAVI 前 3 个月给予，患者在 TAVI 后 3 个月进行随访。纳入标准为缺铁，定义为血清铁蛋白<100µg/L 或铁蛋白在 100 至 300µg/L 之间，同时转铁蛋白饱和度<20%，并签署书面知情同意书。排除标准包括血红蛋白<10g/dL、红细胞疾病、终末期肾病、对铁右旋糖酐不耐受以及正在发生感染。主要终点是 TAVI 后 3 个月时 6 分钟步行试验（6MWT）的基线调整后步行距离。次要终点包括生活质量、纽约心脏协会功能分级（NYHA 功能分级）和骨骼肌力量。
该研究已获得挪威东南部地区医学和健康研究委员会和挪威药品管理局的伦理批准。入组已经开始，预计结果将于 2022 年公布。IIISAS 试验的结果将通过在国际和国内会议上的演讲以及在同行评议期刊上的发表来传播。
NCT04206228。
