CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 27 enrolled
Drug / intervention
AVIVO Mobile Patient Management (MPM) System +2 moredevice
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT03507439
NCT03507439N/ACompleted

Real Life Multimarker Monitoring in Patients With Heart Failure

Bayer·interventional·Posted Apr 25, 2018·Updated Jul 3, 2023

In Brief

A clinical study evaluating AVIVO Mobile Patient Management (MPM) System, VitalPatch biosensor, and 1 other intervention for Heart Failure. Completed, enrolled 27 participants across 5 sites in 3 countries.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsHeart Failure
CountriesGermany, Italy, United States
Collaborators--

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedApr 25, 2018
Enrollment StartApr 6, 2018
Primary CompletionDec 30, 2020
Study CompletionMar 12, 2021
TodayJul 2, 2026
Enrollment to primary: 2.7 yearsPosted 8.2 years ago

Interventions

AVIVO Mobile Patient Management (MPM) Systemdevice

Wearable, wireless physiological monitoring and arrhythmia detection system, used by participants for 5 monitoring periods of 5 days each in the study

VitalPatch biosensordevice

Wearable, wireless physiological monitoring and arrhythmia detection system, used by participants for 5 monitoring periods of 5 days each in the study

DynaPort Move Monitordevice

Wearable device for ambulatory monitoring of physical activity, used by participants for 2 monitoring periods of 7 days each in the study