AI-powered vocal monitoring for heart failure home care

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study tests AVATAR-SC, a home monitoring system that uses voice analysis, simple questionnaires, and AI to flag potential worsening of heart failure. It will enroll 60 adults with heart failure, split between recent post-discharge patients and those receiving Levosimendan in a day-hospital. Participants interact with a computer-generated avatar, submit short voice clips, and complete PROMs to help clinicians monitor status. The trial aims to determine feasibility, user acceptability, and adherence in a real-world home setting. Interventions include AVATAR-SC usage and Levosimendan as applicable within the study design.

Why it matters

Who can join: the full rules

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.

Where it's running

• ASST Grande Ospedale Metropolitano Niguarda
  Milan, Ita, Italy Recruiting

Study contacts

• Study coordinator: Alessandro Verde, MD
• Email: alessandro.verde@ospedaleniguarda.it
• Phone: +39026444

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.