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REALIsM-HF Pilot Study

NCT03507439 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 27

Last updated 2023-07-03

Study results available
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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.

Conditions

Interventions

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

Sponsors & Collaborators

Study Design

Allocation
NA
Purpose
DIAGNOSTIC
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-04-06
Primary Completion
2020-12-30
Completion
2021-03-12

Countries

  • United States
  • Germany
  • Italy

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03507439 on ClinicalTrials.gov