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Can your voice predict heart failure? AI avatar study aims to find out

NCT ID NCT07664748

Knowledge-focused Sponsor: Niguarda Hospital Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tests a new home monitoring system called AVATAR-SC that uses a digital avatar to collect voice recordings and symptom questionnaires from heart failure patients. The goal is to see if changes in voice can serve as early warning signs of worsening heart failure. Sixty participants will use the system twice a week for several weeks. This is a feasibility study, meaning it focuses on whether the technology works and is easy to use, not on changing treatment.

What this could mean

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

Active substance
Levosimendan (for one group only; the main intervention is the AVATAR-SC voice analysis platform)
What this could lead to
If successful, this could lead to a simple, home-based voice monitoring tool that helps doctors detect worsening heart failure early and prevent hospital readmissions.
What could go wrong
This is a very early feasibility study with only 60 participants, so it is not designed to prove clinical benefits. The technology may not work reliably in all home settings or may not detect voice changes accurately.

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 60 people

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

Expected to start

Jun 2026

An estimate. Start dates often move.

Expected to finish

May 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 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 * Age ≥ 18 years * Diagnosis of heart failure (NYHA Class II-IV), according to the Diagnosis Related Group (DRG) classification. * Recent discharge following acute heart failure (AHF) or ongoing treatment with Levosimendan in a Day Hospital setting. * Provision of signed informed consent in Italian. * Currently receiving Guideline-Directed Medical Therapy (GDMT) for heart failure Exclusion Criteria: * Inability or incapacity to provide informed consent. * Cognitive impairment severe enough to prevent interaction with the avatar and compromise the reliability of the collected data. * Significant phonation disorders (e.g., results of previous otorhinolaryngological surgery or post-traumatic outcomes). * Inability to manage a compatible device or the device provided by the study for interaction with the AVATAR-SC platform. * Life expectancy of less than 6 months due to concurrent comorbidities. * Technological or language barriers.

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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

    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

  • ASST Grande Ospedale Metropolitano Niguarda

    Milan, Ita, 202162, Italy

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