Table 1.
Primary and secondary objectives of the REALIsM-HF study
| Primary objective | |
| − | Measure and quantify daily physical activity in patients with HFpEF and HFrEF under real-life conditions using the AVIVO MPM patch or VitalPatch, and DynaPort MoveMonitor |
| Secondary objectives | |
| − | Evaluate the association between data from the AVIVO MPM patch/VitalPatch/DynaPort MoveMonitor and adverse event/clinical outcome data from during the study period |
| − | Assess the baseline level, changes over time and variability in tissue impedance, heart rate, respiratory rate, and EKG-derived parameters, and assess the average person-to-person physiological variability and within-patient standard deviation |
| − | Assess the feasibility of physical activity tracking with the AVIVO MPM patch or VitalPatch, and DynaPort MoveMonitor in patients with HF |
| − | Correlate physical activity data from the AVIVO MPM patch or VitalPatch, and DynaPort MoveMonitor |
| − | Evaluate the relationship of physical activity levels, tissue impedance, heart rate, respiratory rate, and EKG-derived parameters with important measures in HFpEF, such as QoL, PROs, biomarkers, and clinical outcomes (e.g., endpoints such as hospitalization for HF, cardiovascular death, emergency visits) |
| − | Support the development of HFpEF-specific questions (PROs) for cross-sectional and longitudinal testing/validating |
| − | Determine the variability of device-derived biomarkers between and within patients over time, and validate the use of suitable biomarkers for clinical use in the context of HF |
| − | Explore longitudinal changes in transcutaneous thoracic impedance measurement (by the AVIVO MPM patch) as a surrogate for fluid status in patients with acute HF and after stabilization |
| − | Evaluate hs-copeptin as a potential biomarker in HF (as a surrogate marker for arginine vasopressin) |
| − | Correlate blood-based biomarkers of congestion (e.g., NTproBNP/hs-copeptin) with a functional marker (e.g., impedance; AVIVO MPM patch) |
| − | Correlate data collected from the AVIVO MPM patch/VitalPatch and inpatient clinical data collected during hospital stays (e.g., echocardiography, weight gain/loss, NYHA class, and heart rate) |
| − | Explore the relationship between physical activity, 6MWD, PROs, biomarkers, and adverse events/clinical outcomes |
| − | Investigate the accuracy of patients' self-reports (PROs and KCCQ) of time spent undertaking physical activity in real life vs. objective assessment by the AVIVO MPM patch or VitalPatch, and DynaPort MoveMonitor |
6MWD, 6-min walking distance; EKG, electrocardiogram; HF, heart failure; HFpEF, HF with preserved ejection fraction; HFrEF, HF with reduced ejection fraction; hs-copeptin, high-sensitivity copeptin; KCCQ, Kansas City Cardiomyopathy Questionnaire; MPM, Mobile Patient Management; NTproBNP, N-terminal pro-brain natriuretic peptide; NYHA, New York Heart Association; PRO, patient-reported outcome; QoL, quality of life; REALIsM-HF, Real-Life Multimarker Monitoring in Patients with Heart Failure.