Heart FailureOPTIMUMNCT07439081
OPTIMUM Study of Remote Patient Monitoring in Ambulatory Heart Failure Care
A study testing Satelia® Cardio Remote Patient Monitoring System in people with Heart Failure and Acute Heart Failure (AHF), run by Médipôle Lyon-Villeurbanne at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Acute Heart Failure (AHF)
- What is being tested?
- Satelia® Cardio Remote Patient Monitoring System
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 504 participants
- Where
- 1 siteFrance
- Study dates
- 1 Jan 2021to 1 Jul 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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,interventional 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 and during the 5-year-follow-up. The primary outcome was the number of cardiac rehospitalizations. Secondary outcomes included all-cause hospitalizations during 5 years after inclusion, mortality up to 5 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)
- Being tested
- Satelia® Cardio Remote Patient Monitoring System
- Keywords
- Remote patient monitoring, Transitional care, Ambulatory care, Disease management, Frailty
- Medical subject headings
- Heart Failure, Frailty
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Satelia® Cardio Remote Patient Monitoring SystemDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| Integrated Ambulatory Heart Failure Care Pathway | Experimental | 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. Receives: Device: Satelia® Cardio Remote Patient Monitoring System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year before enrollment and 1 year after enrollment
Secondary outcomes (5)
All-Cause Hospitalizations
Total number of hospital admissions for any cause during the 12 months following enrollment and during the 5-year-follow-up compared with the 12 months preceding enrollment.
Measured: 1 year before enrollment and 5 years after enrollment
All-Cause Mortality
Death from any cause among enrolled participants
Measured: Up to 5 years after enrollment
Cardiovascular Mortality
Death attributed to cardiovascular causes based on clinical records.
Measured: Up to 5 years 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.
Measured: 5 years
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
Measured: At the end of follow up or the study period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2026
- Study start1 Jan 2021
- Primary completion1 Jul 2023
- Study completion1 Jul 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Interventional study evaluating the clinical benefit of a comprehensive heart failure management program. The multimodal intervention combines remote patient monitoring, regular laboratory monitoring, multidisciplinary ambulatory assessment, and nurse-led therapeutic support in patients with chronic heart failure. The study is conducted as a prospective interventional study (RIPH2, minimal risks and constraints).
- Masking
- None (open label)
- Enrolment
- 504 participants (actual)
Sponsor and investigators
- Lead sponsor
- Médipôle Lyon-Villeurbanne
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mehdi Aleyan, MD, Principal investigator, Department of Cardiology, Médipôle Hôpital Mutualiste
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07439081
- Sponsor's protocol ID
- OPTIMUM
- Acronym
- OPTIMUM
- Status last verified
- Oct 2026
- First submitted
- 6 Feb 2026
- Last updated
- 16 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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
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.
PubMed 37244215Girerd 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.
PubMed 39807086Pages 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.
PubMed 36034602
Study at a glance
From the registry record, last updated by the sponsor on 16 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- OPTIMUM: OPTIMisation du Parcours de Soins du Patient Insuffisant Cardiaque Chronique
- ClinicalTrials.gov ID
- NCT07439081
- Acronym / sponsor ID
- OPTIMUM / OPTIMUM
- Conditions
- Heart Failure, Acute Heart Failure (AHF)
- Keywords
- Remote patient monitoring, Transitional care, Ambulatory care, Disease management, Frailty
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 504 participants (actual)
- Lead sponsor
- Médipôle Lyon-VilleurbanneUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Jul 2025 (actual)
- First posted
- 27 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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,interventional 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 and during the 5-year-follow-up. The primary outcome was the number of cardiac rehospitalizations. Secondary outcomes included all-cause hospitalizations during 5 years after inclusion, mortality up to 5 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 design
- Primary purpose
- Other
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Interventional study evaluating the clinical benefit of a comprehensive heart failure management program. The multimodal intervention combines remote patient monitoring, regular laboratory monitoring, multidisciplinary ambulatory assessment, and nurse-led therapeutic support in patients with chronic heart failure. The study is conducted as a prospective interventional study (RIPH2, minimal risks and constraints).
| Arm | Type | Receives |
|---|---|---|
| Integrated Ambulatory Heart Failure Care Pathway | Experimental | Device: Satelia® Cardio Remote Patient Monitoring SystemPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Satelia® Cardio Remote Patient Monitoring SystemA 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. | Device | Integrated Ambulatory Heart Failure Care Pathway |
Primary outcome
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.
5 secondary outcomes
All-Cause Hospitalizations
Time frame: 1 year before enrollment and 5 years after enrollment
All-Cause Mortality
Time frame: Up to 5 years after enrollment
Cardiovascular Mortality
Time frame: Up to 5 years after enrollment
Remote Patient Monitoring Alert Activity
Time frame: 5 years
Patient and Healthcare Professional Satisfaction with the Care Pathway
Time frame: At the end of follow up or the study period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Oct 2026.
- BackgroundAleyan 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: PubMed 37244215Jourdain 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.
- Background: PubMed 39807086Girerd 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.
- Background: PubMed 36034602Pages 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Mehdi Aleyan, MD principal investigator
Department of Cardiology, Médipôle Hôpital Mutualiste
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Satelia® Cardio Remote Patient Monitoring System in people with Heart Failure and Acute Heart Failure (AHF), run by Médipôle Lyon-Villeurbanne at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Cardiac Rehospitalizations (time frame: 1 year before enrollment and 1 year after enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07439081, which also lists 4 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2026.