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OPTIMUM Study of Remote Patient Monitoring in Ambulatory Heart Failure Care

NCT07439081 · Status: COMPLETED · Type: OBSERVATIONAL · Enrollment: 504

Last updated 2026-02-27

No results posted yet for this study

Summary

Heart failure is a leading cause of hospitalization and readmission, particularly among older adults with multiple comorbidities. Traditional outpatient follow-up may be insufficient to detect early clinical deterioration in this vulnerable population. Remote patient monitoring (RPM) using non-invasive symptom and weight tracking has been proposed to enhance ambulatory care, but its effectiveness appears to depend on integration within structured care pathways.

The OPTIMUM study evaluated the real-world implementation of an integrated ambulatory heart failure care pathway combining non-invasive RPM with multidisciplinary follow-up in routine clinical practice. Patients enrolled after a recent heart failure hospitalization were managed using the Satelia® Cardio monitoring system, nurse-led therapeutic education, and a planned cardio-geriatric day-hospital reassessment. The study aimed to describe pathway implementation and assess associations with rehospitalizations, mortality, alert activity, and patient and healthcare professional satisfaction in an older, frail population.

Conditions

Interventions

DEVICE

Satelia® Cardio Remote Patient Monitoring System

A non-invasive remote patient monitoring system based on regular patient-reported symptom questionnaires and body weight measurements. A built-in algorithm generates color-coded alerts (green, orange, red) to support early detection of potential heart failure decompensation. Alerts are reviewed by healthcare professionals as part of routine care.

Sponsors & Collaborators

  • Médipôle Lyon-Villeurbanne

    lead OTHER

Principal Investigators

  • Mehdi Aleyan, MD · Department of Cardiology, Médipôle Hôpital Mutualiste

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-01-01
Primary Completion
2023-07-01
Completion
2025-07-01

Countries

  • France

Study Locations

More Related Trials

Entities

Diseases

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 NCT07439081 on ClinicalTrials.gov