Real-Life Multimarker Monitoring in Patients with Heart Failure: Continuous Remote Monitoring of Mobility and Patient-Reported Outcomes as Digital End Points in Future Heart-Failure Trials.

Q1 Computer Science
Digital Biomarkers Pub Date : 2020-06-30 eCollection Date: 2020-05-01 DOI:10.1159/000507696
Frank Kramer, Javed Butler, Sanjiv J Shah, Christian Jung, Savina Nodari, Stephan Rosenkranz, Michele Senni, Luke Bamber, Stephan Cichos, Chrysanthi Dori, Toeresin Karakoyun, Gabriele Jenny Köhler, Kinjal Patel, Paolo Piraino, Thomas Viethen, Praneeth Chennuru, Ayse Paydar, Jason Sims, Richard Clark, Rob van Lummel, Alexandra Müller, Chad Gwaltney, Salko Smajlovic, Hans-Dirk Düngen, Wilfried Dinh
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引用次数: 7

Abstract

Aims: Heart failure (HF) affects approximately 26 million people worldwide. With an aging global population, innovative approaches to HF evaluation and management are needed to cope with the worsening HF epidemic. The aim of the Real-Life Multimarker Monitoring in Patients with Heart Failure (REALIsM-HF) study (NCT03507439) is to evaluate a composite instrument comprising remote, real-time, activity-monitoring devices combined with daily electronic patient-reported outcome (ePRO) items in patients who have been hospitalized for HF and are undergoing standard HF assessment (e.g., 6-min walking distance [6MWD], blood biomarkers, Kansas City Cardiomyopathy Questionnaire [KCCQ], and echocardiography).

Methods: REALIsM-HF is an ongoing, 12-week, observational study enrolling 80-100 patients aged ≥45 years with HF with preserved ejection fraction (HFpEF; EF ≥45%) or reduced EF (HFrEF; EF ≤35%). Statistical analyses will include examining the association between data from wearables (the AVIVO© mobile patient management patch or VitalPatch© biosensor, and the DynaPort MoveMonitor©), daily ePROs, and conventional HF metrics (e.g., serum/plasma biomarkers, 6MWD, KCCQ, and echocardiographic parameters). The feasibility of and patient compliance with at-home devices will be documented, and the data captured for the purpose of establishing reference values in patients with HFpEF or HFrEF will be summarized.

Conclusions: The REALIsM-HF study is to evaluate the longitudinal daily activity profiles of patients with HF and correlate these with changes in serum/plasma biomarker profiles, symptoms, quality of life, and cardiac function and morphology to inform the use of wearable activity monitors for developing novel therapies and managing patients.

心衰患者现实生活中的多标记物监测:持续远程监测活动能力和患者报告的结果作为未来心衰试验的数字终点。
目的:心力衰竭(HF)影响全球约2600万人。随着全球人口老龄化,需要创新的心衰评估和管理方法来应对日益恶化的心衰流行。心衰患者现实生活多标志物监测(reality -HF)研究(NCT03507439)的目的是评估一种复合仪器,该仪器包括远程、实时活动监测设备和每日电子患者报告结果(ePRO)项目,用于住院心衰并接受标准心衰评估的患者(例如,6分钟步行距离[6MWD]、血液生物标志物、堪萨斯城心肌病问卷[KCCQ]和超声心动图)。方法:realsm -HF是一项正在进行的为期12周的观察性研究,纳入80-100例年龄≥45岁的HF患者,并保留射血分数(HFpEF;EF≥45%)或降低EF (HFrEF;EF≤35%)。统计分析将包括检查来自可穿戴设备(AVIVO©移动患者管理贴片或VitalPatch©生物传感器和dynapport MoveMonitor©)、每日ePROs和常规HF指标(例如血清/血浆生物标志物、6MWD、KCCQ和超声心动图参数)的数据之间的关联。将记录家用器械的可行性和患者依从性,并总结为HFpEF或HFrEF患者建立参考值而收集的数据。结论:realist -HF研究旨在评估HF患者的纵向日常活动概况,并将其与血清/血浆生物标志物、症状、生活质量、心功能和形态学的变化联系起来,为可穿戴活动监测仪的使用提供信息,以开发新的治疗方法和管理患者。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
Digital Biomarkers
Digital Biomarkers Medicine-Medicine (miscellaneous)
CiteScore
10.60
自引率
0.00%
发文量
12
审稿时长
23 weeks
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