研究动态
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RESILIENCE 的基本原理和设计:一项评估远程缺血调理预防蒽环类药物心脏毒性的前瞻性随机临床试验。

Rationale and design of RESILIENCE: A prospective randomized clinical trial evaluating remote ischaemic conditioning for the prevention of anthracycline cardiotoxicity.

发表日期:2024 Aug 30
作者: Andrea Moreno-Arciniegas, Alberto García, Malte Kelm, Francesco D'Amore, María Gomes da Silva, Javier Sánchez-González, Pedro L Sánchez, Teresa López-Fernández, Raul Córdoba, Riccardo Asteggiano, Vincent Camus, Jouke Smink, Antonio Ferreira, Marie J Kersten, Natacha Bolaños, Noemi Escalera, Elsa Pacella, Sandra Gómez-Talavera, Antonio Quesada, Xavier Rosselló, Borja Ibanez,
来源: EUROPEAN JOURNAL OF HEART FAILURE

摘要:

缺乏能够预防蒽环类药物心脏毒性(AC)的疗法。远程缺血调理 (RIC) 在 AC 临床前模型中显示出有益效果。接受 ANthraCyclinE 的淋巴瘤患者的远程缺血调理 (RESILIENCE) 是一项多国、前瞻性、II 期、双盲、假对照、随机临床试验,旨在评估RIC 对接受蒽环类药物治疗的淋巴瘤患者的疗效和安全性。计划接受≥5个化疗周期(包括蒽环类药物)且具有≥1个AC相关危险因素的患者将在整个化疗期间随机接受每周一次RIC或假手术。患者将在基线、第三个周期后(中间 CMR)和化疗结束后 2 个月接受三项多参数心脏磁共振 (CMR) 研究。此后,将对患者进行临床事件随访,预计中位时间≥24个月。主要终点是基于 CMR 的左心室射血分数 (LVEF) 相对于基线的绝对变化。主要次要结局是 AC 事件的发生率,定义为 (1) 基于 CMR 的 LVEF 下降 ≥10 个绝对点,或 (2) 基于 CMR 的 LVEF 下降 ≥5 且 <10 个绝对点值<50%。中级 CMR 将测试 T2 映射预测 AC 与经典标记物(左心室应变和心脏损伤生物标记物)的能力。允许超快电影采集的新型 CMR 序列将在这一弱势群体中得到验证。RESILIENCE 试验将在一组高危患者中测试 RIC(一种预防 AC 的新型非侵入性干预措施)。该试验还将测试候选标记预测 AC 的能力,并将验证一种新颖的 CMR 序列,减少弱势群体的采集时间。© 2024 作者。约翰·威利出版的《欧洲心力衰竭杂志》
There is a lack of therapies able to prevent anthracycline cardiotoxicity (AC). Remote ischaemic conditioning (RIC) has shown beneficial effects in preclinical models of AC.REmote iSchemic condItioning in Lymphoma PatIents REceiving ANthraCyclinEs (RESILIENCE) is a multinational, prospective, phase II, double-blind, sham-controlled, randomized clinical trial that evaluates the efficacy and safety of RIC in lymphoma patients receiving anthracyclines. Patients scheduled to undergo ≥5 chemotherapy cycles including anthracyclines and with ≥1 AC-associated risk factors will be randomized to weekly RIC or sham throughout the chemotherapy period. Patients will undergo three multiparametric cardiac magnetic resonance (CMR) studies, at baseline, after the third cycle (intermediate CMR), and 2 months after the end of chemotherapy. Thereafter, patients will be followed up for clinical events over an anticipated median of ≥24 months. The primary endpoint is the absolute change from baseline in CMR-based left ventricular ejection fraction (LVEF). The main secondary outcome is the incidence of AC events, defined as (1) a drop in CMR-based LVEF of ≥10 absolute points, or (2) a drop in CMR-based LVEF of ≥5 and <10 absolute points to a value <50%. Intermediate CMR will test the ability of T2 mapping to predict AC versus classical markers (left ventricular strain and cardiac injury biomarkers). A novel CMR sequence allowing ultrafast cine acquisition will be validated in this vulnerable population.The RESILIENCE trial will test RIC (a novel non-invasive intervention to prevent AC) in a cohort of high-risk patients. The trial will also test candidate markers for their capacity to predict AC and will validate a novel CMR sequence reducing acquisition time in a vulnerable population.© 2024 The Author(s). European Journal of Heart Failure published by John Wiley & Sons Ltd on behalf of European Society of Cardiology.