CompletedNot Applicable

Remote Patient Monitoring for Patients With Heart Failure in France

France20,000 participantsStarted 2018-08-01

Plain-language 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.

Who can participate

Age range

18 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Number of All Causes Deaths

Timeframe: August 2018 to December 2021

Trial details

NCT IDNCT06312501

SponsorSatelia

Sponsor typeINDUSTRY

Study typeOBSERVATIONAL

Primary completion2021-12-31

View on ClinicalTrials.gov More Heart Failure trials