Department of Cardiology, Xiangtan Central Hospital, Xiangtan, 411100, China.
Graduate Collaborative Training Base of Xiangtan Central Hospital, Hengyang Medical School, University of South China, Hengyang, China.
ESC Heart Fail. 2022 Aug;9(4):2713-2718. doi: 10.1002/ehf2.13988. Epub 2022 May 20.
Pulmonary congestion (PC) expressed by residual lung ultrasound B-lines (LUS-BL) could exist in some discharged heart failure (HF) patients, which is a known determinant of poor outcomes. Detection efficacy for PC is suboptimal with widely used imaging modalities, like X-ray or echocardiography, while lung ultrasound (LUS) can sufficiently detect PC by visualizing LUS-BL. In this trial, we sought to evaluate the impact LUS-BL-guided intensive HF management post-discharge on outcome of HF patients discharged with residual LUS-BL up to 1 year after discharge. IMP-OUTCOME is a prospective, single-centre, single-blinded, randomized cohort study, which is designed to investigate if LUS-BL-guided intensive HF management post-discharge in patients with residual LUS-BL could improve the clinical outcome up to 1 year after discharge or not.
After receiving the standardized treatment of HF according to current guidelines, 318 patients with ≥3 LUS-BL assessed by LUS within 48 h before discharge will be randomly divided into the conventional HF management group and the LUS-BL-guided intensive HF management group at 1:1 ratio. Patient-related basic clinical data including sex, age, blood chemistry, imaging examination, and drug utilization will be obtained and analysed. LUS-BL will be assessed at 2 month interval post-discharge in both groups, but LUS-BL results will be enveloped in the conventional HF management group, and diuretics will be adjusted based on symptom and physical examination results with or without knowing the LUS-BL results. Echocardiography examination will be performed for all patients at 12 month post-discharge. The primary endpoint is consisted of the composite of readmission for worsening HF and all-cause death during follow up as indicated. The secondary endpoints consisted of the change in the New York Heart Association classification, Duke Activity Status Index, N terminal pro brain natriuretic peptide value, malignant arrhythmia event and 6 min walk distance at each designed follow up, echocardiography-derived left ventricular ejection fraction, and number of LUS-BL at 12 month post-discharge. Safety profile will be recorded and managed accordingly for all patients.
This trial will explore the impact of LUS-BL-guided intensive HF management on the outcome of discharged HF patients with residual LUS-BL up to 1 year after discharge in the era of sodium-glucose cotransporter-2 inhibitors and angiotensin receptor blocker-neprilysin inhibitor.
ClinicalTrials.gov: NCT05035459.
肺部充血（PC）通过残余肺部超声 B 线（LUS-BL）表达，在一些出院的心衰（HF）患者中可能存在，这是预后不良的已知决定因素。广泛使用的成像方式，如 X 射线或超声心动图，对 PC 的检测效果并不理想，而肺部超声（LUS）可以通过可视化 LUS-BL 来充分检测 PC。在这项试验中，我们旨在评估出院后 LUS-BL 指导的强化 HF 管理对出院时仍有 LUS-BL 残留的 HF 患者在出院后 1 年内的结局的影响。IMP-OUTCOME 是一项前瞻性、单中心、单盲、随机队列研究，旨在研究在出院时仍有 LUS-BL 残留的患者中，出院后 LUS-BL 指导的强化 HF 管理是否能改善 1 年后的临床结局。
在接受 HF 标准化治疗后，318 名在出院前 48 小时内通过 LUS 评估至少有 3 条 LUS-BL 的患者将以 1:1 的比例随机分为常规 HF 管理组和 LUS-BL 指导的强化 HF 管理组。将获得和分析患者相关的基本临床数据，包括性别、年龄、血液化学、影像学检查和药物利用情况。两组均在出院后每 2 个月进行 LUS-BL 评估，但 LUS-BL 结果将在常规 HF 管理组中保密，利尿剂将根据症状和体格检查结果进行调整，无论是否知道 LUS-BL 结果。所有患者在出院后 12 个月进行超声心动图检查。主要终点由随访期间因 HF 恶化而再次入院和全因死亡的复合终点组成。次要终点包括纽约心功能协会（NYHA）分级、杜克活动状态指数（Duke Activity Status Index）、N 末端脑钠肽前体（N-terminal pro brain natriuretic peptide，NT-proBNP）值、恶性心律失常事件和 6 分钟步行距离的变化，以及出院后 12 个月的超声心动图左心室射血分数和 LUS-BL 数量。将为所有患者记录安全性概况并相应进行管理。
这项试验将探讨在钠-葡萄糖共转运蛋白 2 抑制剂和血管紧张素受体脑啡肽酶抑制剂时代，LUS-BL 指导的强化 HF 管理对出院时仍有 LUS-BL 残留的 HF 患者 1 年后结局的影响。
ClinicalTrials.gov：NCT05035459。
