Open AccessReal-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
Author(s) -
Kramer Frank,
Butler Javed,
Shah Sanjiv J.,
Jung Christian,
Nodari Savina,
Rosenkranz Stephan,
Senni Michele,
Bamber Luke,
Cichos Stephan,
Dori Chrysanthi,
Karakoyun Toeresin,
Köhler Gabriele Jenny,
Patel Kinjal,
Piraino Paolo,
Viethen Thomas,
Chennuru Praneeth,
Paydar Ayse,
Sims Jason,
Clark Richard,
van Lummel Rob,
Müller Alexandra,
Gwaltney Chad,
Smajlovic Salko,
Düngen Hans-Dirk,
Dinh Wilfried
Publication year - 2020
Publication title -
digital biomarkers
Language(s) - English
Resource type - Journals
ISSN - 2504-110X
DOI - 10.1159/000507696
Subject(s) - further section
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.