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Completed

NCT Number: NCT07439081

OPTIMUM Study of Remote Patient Monitoring in Ambulatory Heart Failure Care

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Médipôle Hôpital Mutualiste

Lyon, Auvergne-Rhône-Alpes, 69100, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Primary outcomes

  1. Number of Cardiac Rehospitalizations

    Time frame: 1 year before enrollment and 1 year after enrollment

    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.

Secondary outcomes

  1. All-Cause Hospitalizations

    Time frame: 1 year before enrollment and 1 year after enrollment

    Total number of hospital admissions for any cause during the 12 months following enrollment compared with the 12 months preceding enrollment.

  2. All-Cause Mortality

    Time frame: Up to 24 months after enrollment

    Death from any cause among enrolled participants

  3. Cardiovascular Mortality

    Time frame: Up to 24 months after enrollment

    Death attributed to cardiovascular causes based on clinical records.

  4. Remote Patient Monitoring Alert Activity

    Time frame: 1 year

    Frequency and distribution of color-coded alerts (green, orange, red) generated by the Satelia® Cardio remote monitoring algorithm during follow-up.

  5. Patient and Healthcare Professional Satisfaction with the Care Pathway

    Time frame: At the end of follow up or the study period

    Self-reported satisfaction and healthcare professional satisfaction with integrated ambulatory care pathway measured using a 10-point Likert scale questionnaire

Sponsors and collaborators

Lead sponsor

Médipôle Lyon-Villeurbanne

Other

Registry information

Official study title

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

Acronym: OPTIMUM

Important dates

Study start
2021
Primary completion
2023
Study completion
2025
First posted
Feb 27, 2026
Registry last updated
Feb 27, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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