Heart FailureTELESAT-HFNCT06312501
Remote Patient Monitoring for Patients With Heart Failure in France
An observational study of Heart Failure and Patient Empowerment, run by Satelia at 1 site in France.
Trial summary
The goal of this multicenter observational longitudinal cohort study is to evaluate the ability of a Remote Patient Monitoring (RPM) program to prevent cardiac decompensation by detecting weak signals of decompensation early in patients with chronic heart failure in France. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure, Patient Empowerment, Cardiac Failure
- What is being tested?
- Satelia®Cardio and Conventional care
- Type of treatment
- Medical device
- How many people
- 20,000 participants
- Where
- 1 siteFrance
- Study dates
- 1 Aug 2018to 31 Dec 2022
- Phase
- Observational
- 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
Study population: 20,000 patients with heart failure across France.
Who may be able to join
- residing in France
- having heart failure
- adults over the age of 18 years
- New York Heart Association (NYHA) score≥2 and Brain Natriuretic Peptid (BNP)>100 pg/ml or N-terminal pro BNP>1000 pg/ml OR prior hospitalization for heart failure
Who cannot join
- physician's assessment deemed patient not be physically or mentally able to be remotely monitored
- had chronic dialysis
- severe liver failure
- the presence of any other medical condition resulting in a less than one-year life expectancy,
- an estimated low adherence to treatment
- lack of a stable place of residence
- refusing to participate in the program ineligible.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluating the Effectiveness of Remote Patient Monitoring (Satelia® Cardio) for Patients With Heart Failure (TELESAT-HF Study)
The goal of this multicenter observational longitudinal cohort study is to evaluate the ability of a Remote Patient Monitoring (RPM) program to prevent cardiac decompensation by detecting weak signals of decompensation early in patients with chronic heart failure in France.
The main question it aims to answer is whether an RPM solution can provide the improvement in overall patient survival
Read more
Participants will answer to questionnaires provided by the RPM solution for the follow-up of their condition.
Researchers will compare the following cohorts to see if RPM can improve their condition:
- Cohort 1: using RPM for follow-ups.
- Cohort 2: conventional care and not using any devices and solutions for the follow-ups.
Read the detailed description
TELESAT study is a national-scale observational prospective cohort study conducted in France from August 2018 to December 2022.
The study was conducted using the French national health data system known as the Système National des Données de Santé (SNDS) which covers approximately 99% of the French population.
- Conditions
- Heart Failure, Patient Empowerment, Cardiac Failure
- Being tested
- Satelia®Cardio, Conventional care
- Keywords
- Remote patient monitoring, Heart failure, Cardiac decompensation, Telehealth
- Medical subject headings
- Heart Failure, Patient Participation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Satelia®CardioDevice
Use of a remote patient monitoring system by NP Medical.
Conventional careOther
No use of RPM solutions for follow-up
| Study group | Role | What they receive |
|---|---|---|
| RPM heart failure patients | Patients that use RPM for the follow-ups of their condition. Receives: Device: Satelia®Cardio | |
| Real-life heart failure patients recieving conventional care | Patients that do not use any medical devices and/or solutions such as RPM for the follow-ups of their condition. Receives: Other: Conventional care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of All Causes Deaths
Number of deaths for any cause
Measured: August 2018 to December 2021
Secondary outcomes (3)
Number of unplanned heart failure Hospitalization
Number of unplanned hospitalization for heart failure
Measured: August 2018 to December 2021
Number of All Causes Deaths in elderly patients
Number of deaths for any cause in the elderly population
Measured: August 2018 to December 2021
Number of unplanned hospitalization for heart failure in elderly patients
Number of unplanned hospitalization for heart failure in elderly patients
Measured: August 2018 to December 2021
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Mar 2024
- Study start1 Aug 2018
- Primary completion31 Dec 2021
- Study completion31 Dec 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 20,000 participants (actual)
Sponsor and investigators
- Lead sponsor
- Satelia
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Nicolas Pages, MD, Study director, NP Medical
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06312501
- Sponsor's protocol ID
- 2021-0020 TELESAT-HF
- Acronym
- TELESAT-HF
- Status last verified
- Mar 2024
- First submitted
- 6 Mar 2024
- Last updated
- 24 Apr 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 36034602Jourdain 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 37244215Creton S, Saadi M, Monfort H, Yaghobian S, Pages N, Nisse-Durgeat S, Diebold B. The Clinical Impact and Good Practices of Remote Patient Monitoring for Chronic Heart Failure: A French Case Report. Patient Prefer Adherence. 2024 Jan 16;18:131-135. doi: 10.2147/PPA.S445638. eCollection 2024.
PubMed 38249685
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Effectiveness of Remote Patient Monitoring (Satelia® Cardio) for Patients With Heart Failure (TELESAT-HF Study)
- ClinicalTrials.gov ID
- NCT06312501
- Acronym / sponsor ID
- TELESAT-HF / 2021-0020 TELESAT-HF
- Conditions
- Heart Failure, Patient Empowerment, Cardiac Failure
- Keywords
- Remote patient monitoring, Heart failure, Cardiac decompensation, Telehealth
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 20,000 participants (actual)
- Lead sponsor
- SateliaIndustry (pharma, biotech, devices)
- Study start
- 1 Aug 2018 (actual)
- Primary completion
- 31 Dec 2021 (actual)
- Study completion
- 31 Dec 2022 (actual)
- First posted
- 15 Mar 2024 (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.
The goal of this multicenter observational longitudinal cohort study is to evaluate the ability of a Remote Patient Monitoring (RPM) program to prevent cardiac decompensation by detecting weak signals of decompensation early in patients with chronic heart failure in France.
The main question it aims to answer is whether an RPM solution can provide the improvement in overall patient survival
Participants will answer to questionnaires provided by the RPM solution for the follow-up of their condition.
Researchers will compare the following cohorts to see if RPM can improve their condition:
- Cohort 1: using RPM for follow-ups.
- Cohort 2: conventional care and not using any devices and solutions for the follow-ups.
Detailed description
TELESAT study is a national-scale observational prospective cohort study conducted in France from August 2018 to December 2022.
The study was conducted using the French national health data system known as the Système National des Données de Santé (SNDS) which covers approximately 99% of the French population.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RPM heart failure patients | – | Device: Satelia®CardioPatients that use RPM for the follow-ups of their condition. |
| Real-life heart failure patients recieving conventional care | – | Other: Conventional carePatients that do not use any medical devices and/or solutions such as RPM for the follow-ups of their condition. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- 20,000 patients with heart failure across France.
Key inclusion criteria (4 listed)
- residing in France
- having heart failure
- adults over the age of 18 years
- New York Heart Association (NYHA) score≥2 and Brain Natriuretic Peptid (BNP)>100 pg/ml or N-terminal pro BNP>1000 pg/ml OR prior hospitalization for heart failure
Key exclusion criteria (7 listed)
- physician's assessment deemed patient not be physically or mentally able to be remotely monitored
- had chronic dialysis
- severe liver failure
- the presence of any other medical condition resulting in a less than one-year life expectancy,
- an estimated low adherence to treatment
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®CardioUse of a remote patient monitoring system by NP Medical. | Device | RPM heart failure patients |
| Conventional careNo use of RPM solutions for follow-up | Other | Real-life heart failure patients recieving conventional care |
Primary outcome
Number of All Causes Deaths
Time frame: August 2018 to December 2021
Number of deaths for any cause
3 secondary outcomes
Number of unplanned heart failure Hospitalization
Time frame: August 2018 to December 2021
Number of All Causes Deaths in elderly patients
Time frame: August 2018 to December 2021
Number of unplanned hospitalization for heart failure in elderly patients
Time frame: August 2018 to December 2021
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 24 Apr 2025.
- 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.
- 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 38249685Creton S, Saadi M, Monfort H, Yaghobian S, Pages N, Nisse-Durgeat S, Diebold B. The Clinical Impact and Good Practices of Remote Patient Monitoring for Chronic Heart Failure: A French Case Report. Patient Prefer Adherence. 2024 Jan 16;18:131-135. doi: 10.2147/PPA.S445638. eCollection 2024.
- Satelia websiteLink provided by the sponsor.
- TELESAT study from the data hubLink provided by the sponsor.
- Individual participant dataSharing planned: No
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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.
Nicolas Pages, MD study director
NP Medical
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Heart Failure and Patient Empowerment, run by Satelia 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 4 inclusion and 7 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 24 Apr 2025. 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 All Causes Deaths (time frame: August 2018 to December 2021). 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 NCT06312501, which also lists 3 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 24 Apr 2025.