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Remote Patient Monitoring for Patients With Heart Failure in France (TELESAT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT06312501
Recruitment Status : Completed
First Posted : March 15, 2024
Last Update Posted : March 15, 2024
Sponsor:
Information provided by (Responsible Party):
Satelia

Brief 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.

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.

Condition or disease Intervention/treatment
Heart Failure Patient Empowerment Cardiac Failure Device: Satelia®Cardio Other: Conventional care

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.

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Study Type : Observational
Actual Enrollment : 20000 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Evaluating the Effectiveness of Remote Patient Monitoring (Satelia® Cardio) for Patients With Heart Failure (TELESAT Study)
Actual Study Start Date : August 1, 2018
Actual Primary Completion Date : December 31, 2021
Actual Study Completion Date : December 31, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Heart Failure

Group/Cohort Intervention/treatment
RPM heart failure patients
Patients that use RPM for the follow-ups of their condition.
Device: Satelia®Cardio
Use of a remote patient monitoring system by NP Medical.

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.
Other: Conventional care
No use of RPM solutions for follow-up




Primary Outcome Measures :
  1. Number of All Causes Deaths [ Time Frame: August 2018 to December 2021 ]
    Number of deaths for any cause


Secondary Outcome Measures :
  1. Number of unplanned heart failure Hospitalization [ Time Frame: August 2018 to December 2021 ]
    Number of unplanned hospitalization for heart failure

  2. Number of All Causes Deaths in elderly patients [ Time Frame: August 2018 to December 2021 ]
    Number of deaths for any cause in the elderly population

  3. Number of unplanned hospitalization for heart failure in elderly patients [ Time Frame: August 2018 to December 2021 ]
    Number of unplanned hospitalization for heart failure in elderly patients



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
20,000 patients with heart failure across France.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT06312501


Locations
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France
NP Medical
Bordeaux, France, 33000
Sponsors and Collaborators
Satelia
Investigators
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Study Director: Nicolas Pages, MD NP Medical
Additional Information:
Publications:
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Responsible Party: Satelia
ClinicalTrials.gov Identifier: NCT06312501    
Other Study ID Numbers: 2021-0020 TELESAT
First Posted: March 15, 2024    Key Record Dates
Last Update Posted: March 15, 2024
Last Verified: March 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Satelia:
Remote patient monitoring
Heart failure
Cardiac decompensation
Telehealth
Additional relevant MeSH terms:
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Heart Failure
Heart Diseases
Cardiovascular Diseases