NCT07439081

OPTIMUM Study of Remote Patient Monitoring in Ambulatory Heart Failure Care

OPTIMUM: OPTIMisation du Parcours de Soins du Patient Insuffisant Cardiaque Chronique

• Status: Completed
• Phase: —
• Study type: Observational
• Enrollment: 504 (actual)
• Sponsor: Médipôle Lyon-Villeurbanne · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Detailed description

Heart failure (HF) is a major cause of hospitalization and rehospitalization among older adults and represents a substantial burden for healthcare systems. Many readmissions occur after discharge for acute heart failure (AHF), often related to delayed recognition of worsening symptoms. While non-invasive remote patient monitoring (RPM) has been proposed as a strategy to extend surveillance into the home setting, previous studies suggest that monitoring alone may be insufficient without integration into structured, multidisciplinary care. OPTIMUM was a prospective, single-center, observational cohort study designed to evaluate the implementation of a structured ambulatory HF care pathway incorporating non-invasive RPM in routine clinical practice. The study was conducted at Médipôle Hôpital Mutualiste in Lyon, France. Adult patients with a recent hospitalization for acute heart failure, or with a history of AHF hospitalization within the prior 12 months, were enrolled into the OPTIMUM care pathway and followed prospectively. The care pathway combined several coordinated components: * Remote patient monitoring (RPM): Patients were monitored using Satelia® Cardio, a non-invasive RPM system based on symptom questionnaires and body-weight measurements. A clinical algorithm generated color-coded alerts (green, orange, red) reflecting estimated risk of decompensation. Alerts were reviewed by healthcare professionals to guide clinical response. * Nurse-led therapeutic education: Structured telephone-based education focused on symptom recognition, treatment adherence, diet, fluid management, and self-care behaviors. * Cardio-geriatric day-hospital reassessment: A planned multidisciplinary outpatient visit approximately one month after inclusion included cardiology and geriatric evaluation, echocardiography, functional assessment, physiotherapy input, nutritional evaluation, and social support assessment when needed. Patients were managed according to routine clinical practice, and no experimental interventions were introduced. The study used a pre-post design comparing outcomes during the 12 months before enrollment with those during the 12 months after enrollment in the pathway. The primary outcome was the number of cardiac rehospitalizations. Secondary outcomes included all-cause hospitalizations, mortality up to two years, frequency and distribution of RPM alerts, and patient and healthcare professional satisfaction. Health-related quality of life and frailty measures were also collected descriptively. OPTIMUM aimed to provide real-world evidence on how RPM can be operationalized within an integrated ambulatory HF care model, particularly in an older, frail population often underrepresented in clinical trials.

Conditions

• Heart Failure
• Acute Heart Failure (AHF)

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2021-01-01
• Primary completion: 2023-07-01
• Completion: 2025-07-01
• First posted: 2026-02-27
• Last updated: 2026-02-27

Locations

1 site across 1 country: France