NCT03507439

REALIsM-HF Pilot Study

Real Life Multimarker Monitoring in Patients With Heart Failure

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Bayer · Industry
• Sex: All
• Age: 45 Years
• Healthy volunteers: Not accepted

Summary

The study aims to explore two marketed devices providing a multimarker monitoring including physical activity under real-life conditions in patients with heart failure with preserved ejection fraction (HFpEF) and with heart failure and reduced ejection fraction (HFrEF). It aims to identify potential novel endpoints for future heart failure trials by exploring clinically relevant changes over time and correlations/associations with conventional endpoints such as the six minute walking distance (6MWD), biomarkers and clinical events. Furthermore, it aims to address the challenges and feasibility of implementing device based measurements under real-life conditions.

Detailed description

Device 1 AVIVO Mobile Patient Management System (Medtronic USA), substituted by VitalPatch biosensor (VitalConnect USA) during the course of the study Device 2 DynaPort Move Monitor (McRoberts, NL)

Conditions

• Heart Failure

Interventions

Type	Name	Description
DEVICE	AVIVO Mobile Patient Management (MPM) System	Wearable, wireless physiological monitoring and arrhythmia detection system, used by participants for 5 monitoring periods of 5 days each in the study
DEVICE	VitalPatch biosensor	Wearable, wireless physiological monitoring and arrhythmia detection system, used by participants for 5 monitoring periods of 5 days each in the study
DEVICE	DynaPort Move Monitor	Wearable device for ambulatory monitoring of physical activity, used by participants for 2 monitoring periods of 7 days each in the study

Timeline

• Start date: 2018-04-06
• Primary completion: 2020-12-30
• Completion: 2021-03-12
• First posted: 2018-04-25
• Last updated: 2023-07-03
• Results posted: 2023-07-03

Locations

5 sites across 3 countries: United States, Germany, Italy