Clin Res Cardiol. 2025 May;114(5):523-531. doi: 10.1007/s00392-025-02626-3. Epub 2025 Apr 29.
Chronic heart failure (HF) is a frequent comorbidity in elderly patients undergoing major non-cardiac surgery with increasing prevalence. This trial aims to evaluate a new interdisciplinary, multimodal and individually optimised treatment strategy in patients with established or at risk for HF throughout the entire perioperative period.
The PeriOP-CARE HF trial is a prospective, multicentre, randomised, controlled and interventional trial. The primary hypothesis is that an interdisciplinary, intersectoral and standardised approach to the preoperative evaluation, optimisation and perioperative management of patients aged ≥ 65 years undergoing non-cardiac surgery with intermediate or high surgical risk and preoperative N-terminal pro-brain natriuretic peptide levels ≥ 450 pg/mL, will reduce postoperative morbidity. The preoperative evaluation includes clinical evaluations by anaesthesiologists and cardiologists, electrocardiography and echocardiography, as well as a discussion of these findings by a perioperative management team, where all involved specialities, including the speciality surgeon, will decide the perioperative treatment strategy for each patient. Intraoperative strategies include individualised haemodynamic optimisation. The interdisciplinary team and specialised HF nurses will screen patients for HF-related postoperative complications. The primary end point will be a composite morbidity end point, comprising any rehospitalisation, acute kidney injury, suspected or proven bacterial infection requiring treatment and acute decompensated HF at postoperative day 90.
The new treatment form can potentially reduce the morbidity burden after major non-cardiac surgery in patients with known or unknown HF. If the PeriOP-CARE HF trial yields positive results, the treatment of patients with HF undergoing major non-cardiac surgery could be considerably improved.
clinicaltrials.gov: NCT06381427, registered April 24, 2024.
慢性心力衰竭（HF）是接受重大非心脏手术的老年患者中常见的合并症，且患病率不断上升。本试验旨在评估一种新的跨学科、多模式且个体化优化的治疗策略，用于在整个围手术期已确诊或有HF风险的患者。
围手术期心脏护理HF试验是一项前瞻性、多中心、随机、对照和干预性试验。主要假设是，对于年龄≥65岁、接受具有中度或高度手术风险的非心脏手术且术前N末端脑钠肽前体水平≥450 pg/mL的患者，采用跨学科、跨部门和标准化的术前评估、优化及围手术期管理方法，将降低术后发病率。术前评估包括麻醉医生和心脏病专家的临床评估、心电图和超声心动图检查，以及由围手术期管理团队对这些检查结果进行讨论，所有参与的专业人员，包括专科外科医生，将为每位患者确定围手术期治疗策略。术中策略包括个体化的血流动力学优化。跨学科团队和专业的HF护士将对患者进行HF相关术后并发症筛查。主要终点将是一个复合发病率终点，包括任何再入院、急性肾损伤、需要治疗的疑似或确诊细菌感染以及术后第90天的急性失代偿性HF。
这种新的治疗方式有可能减轻已知或未知HF患者在重大非心脏手术后的发病负担。如果围手术期心脏护理HF试验产生阳性结果，那么接受重大非心脏手术的HF患者的治疗可能会得到显著改善。
clinicaltrials.gov：NCT06381427，于2024年4月24日注册。
