OPTIMUM Study of Remote Patient Monitoring in Ambulatory Heart Failure Care

NCT07439081 | Completed

• 1 other identifier: OPTIMUM
• Study Type: observational
• Target: 504
• Locations: 1 country
• Sites: 1

Brief 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

Heart Failure; Acute Heart Failure (AHF)

Keywords

Remote patient monitoring; Transitional care; Ambulatory care; Disease management; Frailty

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• All-Cause Hospitalizations

  1 year before enrollment and 1 year after enrollment

• All-Cause Mortality

  Up to 24 months after enrollment

• Cardiovascular Mortality

  Up to 24 months after enrollment

• Remote Patient Monitoring Alert Activity

  1 year

• Patient and Healthcare Professional Satisfaction with the Care Pathway

  At the end of follow up or the study period

Study Arms (1)

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

Interventions

Satelia® Cardio Remote Patient Monitoring System DEVICE

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.

Integrated Ambulatory Heart Failure Care Pathway

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Médipôle Lyon-Villeurbanne: lead

Study Sites (1)

Médipôle Hôpital Mutualiste

Lyon, Auvergne-Rhône-Alpes, 69100, France

Location

Related Publications (4)

• 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

  BACKGROUND

• 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.

  PMID: 37244215 BACKGROUND

• 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.

  PMID: 39807086 BACKGROUND

• 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.

  PMID: 36034602 BACKGROUND

MeSH Terms

Conditions

Heart Failure; Frailty

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Mehdi Aleyan, MD

  Department of Cardiology, Médipôle Hôpital Mutualiste

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 6, 2026
• First Posted: February 27, 2026
• Study Start: January 1, 2021
• Primary Completion: July 1, 2023
• Study Completion: July 1, 2025
• Last Updated: February 27, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)