AimsPilot studies indicate that immunoadsorption with subsequent IgG substitution (IA/IgG) induces beneficial effects in patients with dilated cardiomyopathy (DCM) and heart failure. This placebo‐controlled study investigates whether IA/IgG treatment enhances left ventricular (LV) systolic function as compared to a control group receiving pseudo‐treatment.MethodsThis multicentre, randomized, double‐blind, parallel‐group trial aims to include 200 patients with heart failure due to DCM (LV ejection fraction [LVEF] <40%) on optimized guideline‐directed heart failure medication. Participants are randomly assigned in a 1:1 ratio to IA/IgG using protein‐A columns, or to pseudo‐immunoadsorption followed by an intravenous infusion without IgG. Follow‐up visits take place by telephone after 1 and 3 months and at the study centres after 6, 12 and 24 months. The primary efficacy endpoint is the change in LVEF from baseline to 6 months determined by contrast echocardiography, analysed at a core lab. In addition, LV end‐diastolic and end‐systolic volumes will be analysed as secondary endpoints over the entire study period to assess whether IA/IgG affects LV remodelling. As main secondary outcome, a composite of all‐cause death, cardiac resuscitation, hospitalization for heart failure, and need for cardiac surgery to improve myocardial pump function will be evaluated after 24 months. In addition, exploratory outcomes as well as safety endpoints related to the treatment will be assessed throughout the whole study period.ConclusionIASO‐DCM is a randomized study which will provide comprehensive insights into the effects of immunoadsorption with subsequent IgG substitution in patients with DCM.

中文翻译：

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关于免疫吸附对扩张型心肌病 (IASO-DCM) 患者心功能影响的多中心、随机、双盲、前瞻性研究：基本原理和设计


AimsPilot 研究表明，免疫吸附和随后的 IgG 替代 (IA/IgG) 对扩张型心肌病 (DCM) 和心力衰竭患者产生有益效果。这项安慰剂对照研究调查了与接受伪治疗的对照组相比，IA/IgG 治疗是否能增强左心室 (LV) 收缩功能。 方法这项多中心、随机、双盲、平行组试验旨在纳入 200 名心脏病患者。因 DCM（左心室射血分数 [LVEF]<40%）而导致优化指南指导的心力衰竭药物治疗失败。参与者使用 Protein-A 柱以 1:1 的比例随机分配至 IA/IgG，或分配至假免疫吸附，然后静脉输注不含 IgG。 1 个月和 3 个月后通过电话进行随访，6 个月、12 个月和 24 个月后在研究中心进行随访。主要疗效终点是通过对比超声心动图确定的 LVEF 从基线到 6 个月的变化，并在核心实验室进行分析。此外，左心室舒张末期和收缩末期容积将作为整个研究期间的次要终点进行分析，以评估 IA/IgG 是否影响左心室重塑。作为主要的次要结局，将在 24 个月后评估全因死亡、心脏复苏、心力衰竭住院以及需要进行心脏手术以改善心肌泵功能的综合结果。此外，将在整个研究期间评估与治疗相关的探索性结果以及安全性终点。结论IASO-DCM 是一项随机研究，它将提供有关 DCM 患者免疫吸附和随后 IgG 替代的影响的全面见解。