Can smart monitoring keep heart patients out of the hospital?
NCT ID NCT07008729
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests a digital platform that collects health data from heart failure patients, heart transplant recipients, and those with heart pumps. 390 participants will use sensors and a mobile app to track vital signs, activity, and more. Doctors in the intervention group can see this data to guide care, while the control group's data is hidden. The goal is to see if this monitoring reduces deaths and hospital stays over 18 months.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- Heart monitoring devices and a digital platform
- What this could lead to
- If successful, this could give doctors a powerful tool to remotely monitor heart failure patients, potentially reducing hospital visits and improving daily life.
- What could go wrong
- This is an early-stage study focused on data collection, not a treatment. The platform may not significantly change outcomes, and results may not apply to all patients.
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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390 people
The number who actually took part.
- Started
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Apr 2024
- Expected to finish
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Aug 2026
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 75 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 of 18-75 years. * Ability to understand and provide consent in order to participate in the study. * Have a cognitive assessment score of \> 22 as assessed by the Montreal Cognitive Assessment (MoCA), ( adults without or with mild cognitive impairment at most). * Have a depression score as assessed by Personal Health Questionnaire-9 (PHQ-9) score \< 10. * Provide written informed consent. * For Heart Failure patients: 1) have a diagnosis of symptomatic heart failure (class II or III according to the New York Heart Association Classification); 2) have echocardiographically determined left ventricular ejection fraction (LVEF) ≤40%; 3) have been hospitalized due to cardiovascular reasons or had urgent visit to the Emergency Department due to decompensated HF that required administration of intravenous diuretics within the last 12 months before randomization (Currently hospitalized patients can be included provided they do not fulfill exclusion criterion of being currently with in-hospital administration of IV diuretics/vasoactive/inotropic drugs). * For patients with ventricular assist devices (VAD): have left ventricular assist device (LVAD) implanted either as destination therapy or as bridge-to-transplantation, within at least 90 days and no longer than 48 months before randomization * for heart transplant recipients: have been discharged following heart transplantation within at least 30 days and no longer than 36 months before study randomization. Exclusion Criteria: * Is clinically unstable at the time of randomization as defined by: administration of intravenous diuretics during the last 12 hours or intravenous vasodilators or inotropes during the last 48 hours before randomization. * Has acute coronary syndrome within the last 30 days before randomization. * Has acute inflammatory heart disease, (for instance, acute myocarditis), within 90 days prior to randomization. * Has a planned revascularisation, cardiac resynchronization therapy (CRT) implantation or any valvular procedures within 3 months after randomization * Has known current alcohol or illicit drug abuse. * Shows significant impairment or unwillingness to use the telemonitoring equipment (for instance, dementia, impaired self-determination, lacking ability to communicate). * Has any severe non-cardiovascular disease limiting life expectancy to less than 1 year. * Is pregnant. * Participates currently in other telemonitoring programs/studies using smart devices
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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.
Contacts and locations
Locations
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Alma Mater Studiorum - Universita Di Bologna
Bologna, Italy
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Hospital Universitario Puerta de Hierro
Majadahonda, Madrid, 28222, Spain
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Hospital Universitario Ramón Y Cajal
Madrid, Spain
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Medizinische Hochschule Hannover ('Mhh')
Hanover, Germany
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National and Kapodistrian University of Athens
Athens, Greece
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Onassis Cardiac Surgery Center
Athens, Greece
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