Wearable patch could spot heart failure danger signs before they strike
NCT ID NCT07345533
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
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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
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About 70 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jul 2025
- Expected to finish
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Mar 2028
An estimate. End dates often move.
- Lead sponsor
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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
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18 to 90 years
- Sex
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Anyone
- Healthy volunteers
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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 Hide 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.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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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
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Caen University Hospital
RECRUITINGCaen, France
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