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

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 LummelAlexandra Müller, Chad Gwaltney, Salko Smajlovic, Hans Dirk Düngen, Wilfried Dinh

*Corresponding author for this work

Research output: Contribution to journalArticlepeer-review

6 Scopus citations

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.

Original languageEnglish (US)
Pages (from-to)45-59
Number of pages15
JournalDigital Biomarkers
Volume4
Issue number2
DOIs
StatePublished - 2020

ASJC Scopus subject areas

  • Computer Science Applications
  • Medicine (miscellaneous)
  • Health Informatics

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