Artificial Voice Analysis and Telemonitoring for Heart Failure. A Feasibility Study

Starting soon · Not applicable

Conditions studied: Heart Failure

In brief

Heart failure is a serious condition and a major reason why older adults are admitted to the hospital. Even after going home, many patients struggle to get the follow-up care they need, leading to high rates of return to the hospital. While remote monitoring technology exists, it is often difficult to use, expensive, or hard for doctors to interpret. Recent research suggests that changes in a person's voice and speech can be early warning signs of worsening heart failure, but we need to test if this can work reliably in a home setting.This study tests a new, user-friendly platform called AVATAR-SC. This system uses a a computer-generated character to interact with patients. By analyzing short voice clips and simple health questionnaires provided by the patient, the system aims to make home monitoring easier and more effective. The study will involve 60 participants divided into two groups:half of the patients who have recently been discharged from the hospital following a heart failure episode; the other 30 patients who visit the hospital monthly for a specific heart failure treatment (Levosimendan). Participants will interact with the digital avatar twice a week. During these sessions, they will provide brief voice recordings and answer a few questions about how they feel. It is important to note that the AI in this study is not making medical decisions or changing the patient's current treatment; it is strictly being tested to see how well the technology functions. As a feasibility study, the primary goal is to evaluate the practical implementation of the technology rather than clinical outcomes. The research focuses on: Determining if patients can navigate the system easily and independently, Assessing how consistently participants engage with the scheduled sessions, Verifying the technical reliability of the platform in a home environment,identifying the strengths and challenges of the system to prepare for future, larger-scale trials. Benefits: Participants may feel more supported and more aware of their symptoms through regular check-ins. Risks: The risks are very low. They mostly involve getting used to new technology and ensuring that personal data is kept private and secure. Impact If successful, AVATAR-SC could lead to a new way for doctors to keep an eye on heart failure patients at home, catching problems early through the sound of their voice and preventing unnecessary hospital visits.

Key facts

Study ID: NCT07664748
Run by: Niguarda Hospital
People needed: 60
Starts: 2026-06-30
Expected to finish: 2028-05-15
Last updated by the study team: 2026-06-24

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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 is running

ASST Grande Ospedale Metropolitano Niguarda — Milan, Ita, Italy

Full record on ClinicalTrials.gov

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