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Wearable patch could spot heart failure danger signs before they strike

NCT ID NCT07345533

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing a skin patch called MyHeartSentinel that records heart electrical and mechanical signals in people with heart failure. Researchers want to see if the patch can detect early signs of a worsening episode (decompensation) while patients are in the hospital and after they go home. The goal is to build a database to train an algorithm that could one day alert doctors early, but this study itself does not provide treatment.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
MyHeartSentinel System cutaneous device
What this could lead to
If successful, this could lead to a home monitoring system that alerts doctors early when heart failure worsens, potentially reducing hospital visits.
What could go wrong
This is an early exploratory study with only 70 participants, so results may not apply to all patients. The device is not yet proven to prevent hospitalizations.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 70 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2025

Expected to finish

Mar 2028

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 90 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * Patients aged between 18 and 90 years * Affiliated with the social security system. * Patients who have been informed of the study and have signed informed consent. * Patients with heart failure and one of the following two criteria: * Hospitalized for hemodynamic assessment * Hospitalized in a cardiology unit (ICU or telemetry unit) for congestive decompensation of known heart failure defined by \[8\] minimal dyspnea at rest or during exercise AND an elevation of BNP \> 400 µg/ml or NT-proBNP \> 1600 µg/ml Exclusion Criteria: * Patient hospitalized for decompensated heart failure due to an infectious cause requiring antibiotic treatment * Patient requiring intravenous inotropes within the last 24 hours * Patient with ventricular arrhythmias or permanent AF * ACS with ST+ complex complicated by heart failure * Valvulopathy awaiting interventional management * Pericardial constriction * Pregnant or breastfeeding women * Women of childbearing potential without effective contraception * Patients under guardianship, curatorship, legal protection, or legal protection. * Patients already enrolled in an interventional clinical trial that may impact the electrophysiological and cardiac mechanical measurements of the medical device under study. • Inability to position the sensor on the thoracic area of interest * Patients with open wounds, recent scars, or skin infections at the intended SCOUT device placement site * Patients suffering from dermatitis, eczema, psoriasis, or other skin conditions at the placement site. * Physical or psychological inability of the patient or caregiver to use the digital medical telemonitoring device and/or its collection accessories, as determined by the physician wishing to include the patient in the medical telemonitoring project; * Patient refusal to transmit the data necessary to monitor the effective use of the DMN and to obtain individualized or national real-life usage results; * Patient refusal to receive therapeutic support.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Caen University Hospital

    RECRUITING

    Caen, France

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