Smart vest for heart patients: could it cut hospital readmissions?
NCT ID NCT07622472
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a wearable device that tracks heart rate, breathing, activity, and fluid buildup in people recently hospitalized for heart failure. 800 participants will either get standard care or standard care plus the device for 90 days. The goal is to see if early alerts from the device help doctors prevent serious events like death or rehospitalization.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Wearable monitoring device (Heart Failure Management System)
- What this could lead to
- If successful, this device could help doctors detect worsening heart failure early and reduce hospital visits and deaths.
- What could go wrong
- The trial hasn't started yet, and it's unclear if the device will meaningfully improve outcomes over standard care. Device data may lead to false alarms or missed warnings.
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 800 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Oct 2026
An estimate. Start dates often move.
- Expected to finish
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Aug 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
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 85 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: * Age ≥18 years * Ability and willingness to provide written informed consent and comply with study procedures * Hospital admission for acute heart failure with dyspnea at rest and pulmonary congestion on chest X-ray, and other signs and/or symptoms of heart failure such as edema and/or positive rales on auscultation. * All measures within 24 hours prior to randomization of systolic blood pressure ≥ 100 mmHg, and of heart rate ≥ 60 bpm. * All measures within 24 hours prior to randomization of serum potassium ≤ 5.5 mEq/L (mmol/L). * Biomarker criteria for persistent congestion: * NT-proBNP \>1500 pg/mL at the time of admission, and; * NT-proBNP \>1000 pg/mL \>=3 days after initial admission measure * At 1 week prior to admission, either (a) ≤ ½ the optimal dose of ACEi/ARB/ARNi (see Table) prescribed, no beta-blocker prescribed, and ≤ ½ the optimal dose of MRA prescribed or (b) no ACEi/ARB/ARNi prescribed, ≤ ½ the optimal dose of beta-blocker prescribed, and ≤ ½ the optimal dose of MRA prescribed. All study participants prescribed per label and commercially fit with the HFMS device will be eligible for enrollment. Exclusion Criteria: * Age \< 18 years * Clearly documented intolerance to high doses (≥50% of target dose) of beta-blockers. * Clearly documented intolerance to high doses (≥50% of target dose) of RAS blockers (both ACEi and ARB). * Mechanical ventilation (not including CPAP/BIPAP) in the 24 hours prior to Screening. * Significant pulmonary disease contributing substantially to the patients' dyspnea such as FEV1\< 1 liter or need for chronic systemic or nonsystemic steroid therapy, or any kind of primary right heart failure such as precapillary pulmonary hypertension or chronic thromboembolic pulmonary hypertension. * Cardiac surgery within 3 months prior to Screening * Index Event (admission for AHF) triggered primarily by a correctable etiology such as significant arrhythmia (e.g., sustained ventricular tachycardia, or atrial fibrillation/flutter with sustained ventricular response \>130 beats per minute, or bradycardia with sustained ventricular arrhythmia \<45 beats per minute), severe anemia, acute coronary syndrome, pulmonary embolism, planned admission for device implantation or severe nonadherence leading to very significant fluid accumulation prior to admission and brisk diuresis after admission. Troponin elevations without other evidence of an acute coronary syndrome are not excluded. * Uncorrected thyroid disease, active myocarditis, or known amyloid, sarcoidosis, or hypertrophic obstructive cardiomyopathy. * History of heart transplant or on a transplant list, or using or planned to be implanted with a ventricular assist device. * Adhesive allergy/sensitivity (e.g., acrylic adhesives). * Compromised skin at the device application site (wound, severe dermatitis, etc.) . * Having a prescribed wearable cardioverter defibrillator * Pulmonary artery pressure implant (e.g. CardioMems) * Expected survival \<1 year
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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
9 sites in 9 countries. 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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CHU Nancy
Nancy, Grand Est, 54000, France
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Hospital Universitario 12 de Octubre
Madrid, Spain
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Justus-Liebig University Giessen
Giessen, 35390, Germany
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PIM MSWiA Hospital
Warsaw, Poland
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Policlinico Casilino
Roma, Italy
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Southampton University Hospital NHS Foundation Trust
Southampton, United Kingdom
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UMC Utrecht
Utrecht, Netherlands
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University Zurich
Zurich, Switzerland
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Uppsala University Hospital
Uppsala, Sweden
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