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

NCT07664748 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-06-24

No results posted yet for this study

Summary

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.

Conditions

Interventions

OTHER

AVATAR-SC

Patients discharged following hospitalization for acute heart failure will be enrolled in this study arm and will utilize AVATAR\_SC for periodic monitoring

DRUG

Levosimendan

Patients receiving monthly Levosimendan therapy at the ASST GOM Niguarda (Cardiology 2 - Heart Failure and Transplants) will be enrolled for longitudinal voice data collection. This approach captures data across all preclinical stages of the deterioration-compensation cycle, supported by periodic monitoring via the AVATAR-SC platform. Levosimendan will be prescribed as per clinical practice. .

Sponsors & Collaborators

  • Niguarda Hospital

    lead OTHER

Study Design

Allocation
NON_RANDOMIZED
Purpose
HEALTH_SERVICES_RESEARCH
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-06-30
Primary Completion
2027-05-15
Completion
2028-05-15

Countries

  • Italy

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07664748 on ClinicalTrials.gov