OPTIMUM Study of Remote Patient Monitoring in Ambulatory Heart Failure Care (OPTIMUM)

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

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.

Study Overview

• Status: Completed
• Conditions: Heart Failure; Acute Heart Failure (AHF)
• Intervention / Treatment: Device: Satelia® Cardio Remote Patient Monitoring System

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.

• Study Type: Observational
• Enrollment (Actual): 504

Contacts and Locations

Study Locations

• France
  • Auvergne-Rhône-Alpes
    • Lyon, Auvergne-Rhône-Alpes, France, 69100
      • Medipole Hopital Mutualiste

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

The study population consisted of adults with heart failure managed in routine clinical practice at a tertiary care center in Lyon, France. Most participants were enrolled following a recent hospitalization for acute heart failure, while a smaller proportion were included after outpatient evaluation with a history of heart-failure hospitalization within the prior 12 months. The population was predominantly older and medically complex, with a high burden of comorbidities, polypharmacy, and functional vulnerability. Many participants met criteria for frailty and had limitations that could affect self-management, such as mobility impairment, sensory deficits, or cognitive difficulties. Despite this, the majority were living at home at the time of enrollment, often with support from caregivers or community services.This cohort reflects a real-world ambulatory heart failure population at high risk of rehospitalization and functional decline, representative of older patients commonly encoun

Description

Inclusion Criteria:

• Age ≥18 years
• Diagnosis of heart failure
• Hospitalization for acute heart failure or a cardiac cause OR outpatient evaluation with a history of heart-failure hospitalization within the previous 12 months
• Enrollment into the OPTIMUM ambulatory heart failure care pathway
• Ability to provide informed consent
• Agreement to participate in remote patient monitoring

Exclusion Criteria:

• Inability to provide informed consent
• Refusal to participate in remote patient monitoring or the OPTIMUM care pathway
• Physical, cognitive, or psychological limitations incompatible with use of the remote monitoring system
• Treating clinician judged that adherence to telemonitoring would be insufficient
• Presence of a non-cardiac comorbidity associated with an estimated life expectancy of less than 12 months

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort

Intervention / Treatment

Integrated Ambulatory Heart Failure Care Pathway; Patients with a recent hospitalization for acute heart failure (or prior hospitalization within 12 months) who were enrolled in a structured ambulatory care pathway in routine clinical practice. The pathway included non-invasive remote patient monitoring, nurse-led therapeutic education, and a planned multidisciplinary cardio-geriatric outpatient reassessment.

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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Number of Cardiac Rehospitalizations	Total number of hospital admissions with a primary cardiac diagnosis (ICD-10 codes I50.x) occurring during the 12 months following enrollment in the ambulatory care pathway, compared descriptively with the 12 months preceding enrollment.	1 year before enrollment and 1 year after enrollment

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
All-Cause Hospitalizations	Total number of hospital admissions for any cause during the 12 months following enrollment compared with the 12 months preceding enrollment.	1 year before enrollment and 1 year after enrollment
All-Cause Mortality	Death from any cause among enrolled participants	Up to 24 months after enrollment
Cardiovascular Mortality	Death attributed to cardiovascular causes based on clinical records.	Up to 24 months after enrollment
Remote Patient Monitoring Alert Activity	Frequency and distribution of color-coded alerts (green, orange, red) generated by the Satelia® Cardio remote monitoring algorithm during follow-up.	1 year
Patient and Healthcare Professional Satisfaction with the Care Pathway	Self-reported satisfaction and healthcare professional satisfaction with integrated ambulatory care pathway measured using a 10-point Likert scale questionnaire	At the end of follow up or the study period

Collaborators and Investigators

• Sponsor: Médipôle Lyon-Villeurbanne
• Investigators: Principal Investigator: Mehdi Aleyan, MD, Department of Cardiology, Médipôle Hôpital Mutualiste

Publications and helpful links

General Publications

• Pages N, Picard F, Barritault F, Amara W, Lafitte S, Maribas P, Abassade P, Labarre JP, Boulestreau R, Chaouky H, Abdennadher M, Lemieux H, Lasserre R, Bedel C, Betito L, Nisse-Durgeat S, Diebold B. Remote patient monitoring for chronic heart failure in France: When an innovative funding program (ETAPES) meets an innovative solution (Satelia(R) Cardio). Digit Health. 2022 Aug 22;8:20552076221116774. doi: 10.1177/20552076221116774. eCollection 2022 Jan-Dec.
• Jourdain P, Pages N, Amara W, Maribas P, Lafitte S, Lemieux H, Barritault F, Seronde MF, Labarre JP, Chaouky H, Bedel C, Betito L, Nisse-Durgeat S, Picard F. Perceptions and satisfaction of patients with chronic heart failure when using a remote monitoring web application named Satelia(R) Cardio. Ann Cardiol Angeiol (Paris). 2023 Jun;72(3):101606. doi: 10.1016/j.ancard.2023.101606. Epub 2023 May 25. French.
• Aleyan M, Paradisi-Prieur L, Nisse-Durgeat S, et al. Annales de Cardiologie et d'Angéiologie, Volume 72 - Issue 5, November 2023, 101649. doi: 10.1016/j.ancard.2023.101649
• Girerd N, Barbet V, Seronde MF, Benchimol H, Jagu A, Tartiere JM, Hanon O, Picard F, Lafitte S, Lemaitre M, Pages N, Nisse-Durgeat S, Jourdain P. Association of a remote monitoring programme with all-cause mortality and hospitalizations in patients with heart failure: National-scale, real-world evidence from a 3-year propensity score analysis of the TELESAT-HF study. Eur J Heart Fail. 2025 Sep;27(9):1658-1669. doi: 10.1002/ejhf.3563. Epub 2025 Jan 14.

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2021
• Primary Completion (Actual): July 1, 2023
• Study Completion (Actual): July 1, 2025

Study Registration Dates

• First Submitted: February 6, 2026
• First Submitted That Met QC Criteria: February 24, 2026
• First Posted (Actual): February 27, 2026

Study Record Updates

• Last Update Posted (Actual): February 27, 2026
• Last Update Submitted That Met QC Criteria: February 24, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: Frailty; Disease management; Ambulatory care; Transitional care; Remote patient monitoring
• Additional Relevant MeSH Terms: Cardiovascular Diseases; Pathologic Processes; Heart Diseases; Pathological Conditions, Signs and Symptoms; Frailty; Heart Failure
• Other Study ID Numbers: OPTIMUM

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

IPD Plan Description

Individual participant data will not be made publicly available because the dataset contains sensitive health information from a small, single-center cohort, which could increase the risk of participant re-identification despite de-identification procedures.

Data were collected as part of routine clinical care and are subject to French and European data protection regulations (GDPR). Aggregated results are reported in study publications.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No