肺动脉传感器系统压力监测改善心力衰竭结局研究（PASSPORT-HF）：PASSPORT-HF 多中心随机临床试验的原理和设计。
Pulmonary artery sensor system pressure monitoring to improve heart failure outcomes (PASSPORT-HF): rationale and design of the PASSPORT-HF multicenter randomized clinical trial.
机构信息
Comprehensive Heart Failure Center, University and University Hospital Würzburg, Am Schwarzenberg 15, 97078, Würzburg, Germany.
Department of Internal Medicine I, University Hospital Würzburg, Würzburg, Germany.
出版信息
Clin Res Cardiol. 2022 Nov;111(11):1245-1255. doi: 10.1007/s00392-022-01987-3. Epub 2022 Mar 4.
BACKGROUND
Remote monitoring of patients with New York Heart Association (NYHA) functional class III heart failure (HF) using daily transmission of pulmonary artery (PA) pressure values has shown a reduction in HF-related hospitalizations and improved quality of life in patients.
OBJECTIVES
PASSPORT-HF is a prospective, randomized, open, multicenter trial evaluating the effects of a hemodynamic-guided, HF nurse-led care approach using the CardioMEMS™ HF-System on clinical end points.
METHODS AND RESULTS
The PASSPORT-HF trial has been commissioned by the German Federal Joint Committee (G-BA) to ascertain the efficacy of PA pressure-guided remote care in the German health-care system. PASSPORT-HF includes adult HF patients in NYHA functional class III, who experienced an HF-related hospitalization within the last 12 months. Patients with reduced ejection fraction must be on stable guideline-directed pharmacotherapy. Patients will be randomized centrally 1:1 to implantation of a CardioMEMS™ sensor or control. All patients will receive post-discharge support facilitated by trained HF nurses providing structured telephone-based care. The trial will enroll 554 patients at about 50 study sites. The primary end point is a composite of the number of unplanned HF-related rehospitalizations or all-cause death after 12 months of follow-up, and all events will be adjudicated centrally. Secondary end points include device/system-related complications, components of the primary end point, days alive and out of hospital, disease-specific and generic health-related quality of life including their sub-scales, and laboratory parameters of organ damage and disease progression.
CONCLUSIONS
PASSPORT-HF will define the efficacy of implementing hemodynamic monitoring as a novel disease management tool in routine outpatient care.
TRIAL REGISTRATION
ClinicalTrials.gov; NCT04398654, 13-MAY-2020.
背景
通过每日传输肺动脉（PA）压力值对纽约心脏协会（NYHA）心功能 III 级心力衰竭（HF）患者进行远程监测，已显示可减少 HF 相关住院治疗并改善患者生活质量。
目的
PASSPORT-HF 是一项前瞻性、随机、开放、多中心试验，评估使用 CardioMEMS™ HF-System 进行基于血流动力学的、HF 护士主导的护理方法对临床终点的影响。
方法和结果
该 PASSPORT-HF 试验由德国联邦联合委员会（G-BA）委托进行，以确定 PA 压力引导的远程护理在德国医疗保健系统中的疗效。PASSPORT-HF 纳入 NYHA 心功能 III 级、在过去 12 个月内因 HF 住院的成年 HF 患者。射血分数降低的患者必须接受稳定的指南指导药物治疗。患者将以 1:1 的比例随机中央植入 CardioMEMS™传感器或对照。所有患者都将在出院后接受经过培训的 HF 护士提供结构化电话护理的支持。该试验将在大约 50 个研究地点招募 554 名患者。主要终点是在 12 个月随访后，未计划的 HF 相关再住院或全因死亡的复合事件，所有事件将由中央进行裁决。次要终点包括器械/系统相关并发症、主要终点的组成部分、存活天数和住院天数、疾病特异性和一般健康相关生活质量，包括其亚量表，以及器官损伤和疾病进展的实验室参数。
结论
PASSPORT-HF 将确定将血流动力学监测作为一种新型疾病管理工具在常规门诊护理中实施的疗效。
试验注册
ClinicalTrials.gov；NCT04398654，2020 年 5 月 13 日。
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