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New alert system aims to predict heart failure Flare-Ups weeks in advance

NCT ID NCT07281859

Knowledge-focused Sponsor: University of Padova Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study looks at a new alert system called HeartInsight for people with heart failure who have a special implanted heart device. The system monitors seven body signals and warns doctors up to 42 days before a serious heart event. Researchers will follow 100 patients in Italy for 12 months to see how often these alerts lead to helpful actions, like changing medications or scheduling extra visits. The goal is to learn if this technology can improve how heart failure is managed in everyday care.

What this could mean

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

What this could lead to
If successful, this could show that a smart alert system helps doctors catch heart failure worsening earlier, potentially reducing hospital visits.
What could go wrong
This is a small observational study, not a treatment trial. It only tests how alerts are used in practice, so it may not directly improve patient outcomes.

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.

Participants

About 100 people

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

Started

Jun 2025

Expected to finish

Jun 2027

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.

Who is studied

The study population consists of adult patients with heart failure of ischemic or non-ischemic origin who have been recently implanted with a Biotronik implantable cardioverter defibrillator (ICD) or a cardiac resynchronization therapy defibrillator (CRT-D) with atrial sensing capability and Home Monitoring functionality. Eligible patients must have a left ventricular ejection fraction (LVEF) ≤35% and NYHA functional class II or III at the time of device implantation, be in sinus rhythm, and have provided written informed consent. Patients are excluded if they have received the device as a replacement or upgrade, have had the device implanted for more than one year, have permanent or long-standing atrial fibrillation, require atrial pacing due to sinus node disease, are in NYHA Class IV, are scheduled for cardiac surgery within three months, have a life expectancy of less than one year, have unstable residence or insufficient GSM coverage for Home Monitoring, or are pregnant or breas

Ages

18 years and older

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: * The patient has already received a de novo ICD (DR or DX) or CRT-D within no more than one year, according to guidelines, equipped with atrial sensing and a Home Monitoring system. * Documentation of heart failure of ischemic or non-ischemic origin. * At the time of device implantation: ejection fraction ≤35% and NYHA Class II or III. * Sinus rhythm. * Age ≥18 years. * The patient has signed the informed consent for participation. Exclusion Criteria: * Patients who have received the implantable device as a replacement or upgrade of a previous one. * Patients who have received the device more than one year ago. * At the time of enrollment: patient with HeartInsight previously activated. * Permanent or long-standing atrial fibrillation. * Sinus node disease with indication for atrial pacing. * At the time of enrollment: NYHA Class IV. * Planned cardiac surgery within three months following enrollment. * Life expectancy of less than one year. * Unstable residence or insufficient GSM coverage at the patient's home. * Pregnancy or breastfeeding.

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Conditions

The condition(s) this trial relates to.

heart failure

As listed by the trial registrant

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

Heart failure

How to take part

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

  1. The places running it

    13 sites. 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

  • Clinica Montevergine

    NOT_YET_RECRUITING

    Mercogliano, Avellino, 83013, Italy

  • Maria Cecilia Hospital

    RECRUITING

    Cotignola, Ravenna, 48033, Italy

  • Ospedale Civile SS. Annunziata

    RECRUITING

    Sassari, Sassari, 07100, Italy

  • Ospedale Fracastoro

    RECRUITING

    San Bonifacio, Verona, 37047, Italy

  • Ospedale Giovanni Paolo II

    RECRUITING

    Ragusa, Ragusa, 97100, Italy

  • Ospedale Magalini di Villafranca

    RECRUITING

    Villafranca di Verona, Verona, 37069, Italy

  • Ospedale Mater Salutis di Legnagno

    RECRUITING

    Legnago, Verona, 37045, Italy

  • Ospedale Monaldi

    NOT_YET_RECRUITING

    Naples, Napoli, 80131, Italy

  • Ospedale Monaldi

    NOT_YET_RECRUITING

    Naples, Napoli, 80131, Italy

  • Ospedale San Gerardo

    NOT_YET_RECRUITING

    Monza, Monza, 20900, Italy

  • Ospedale di Cattinara

    NOT_YET_RECRUITING

    Trieste, Trieste, 34149, Italy

  • Presidio Ospedaliero di Rho - ASST Rhodense

    RECRUITING

    Rho, Milano, 20017, Italy

  • Spedali Civili di Brescia

    NOT_YET_RECRUITING

    Brescia, Brescia, 25123, Italy

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