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

NCT07664748 | Not Yet Recruiting

• 2 other identifiers: 7005InnovaWalfare 2025-0158
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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

Heart Failure

Keywords

Vocal biomarkers; Artificial Intelligence; Feasibility Study; Neuropsychological and Psychological Test

Outcome Measures

Primary Outcomes (1)

• Feasability of the AVATAR-SC System in Heart Failure patients

  ≥80% of patients compleating 75% of scheduled interaction

  Through study completion, an average of 3 months per patients

Secondary Outcomes (9)

• Change in Perceived Quality of Life (QoL)

  Through study completion, an average of 3 months per patients

• Change in Vocal Biomarkers Score

  Through study completion, an average of 3 months per patients

• New York Heart Association (NYHA) Functional Class of Heart Failure

  Through study completion, an average of 3 months per patients

• Change in Montreal Cognitive Assessment (MoCA) Score

  Through study completion, an average of 3 months per patients ]

• Change in Frontal Assessment Battery (FAB) Score

  Through study completion, an average of 3 months per patients

Study Arms (2)

AVATAR_SC Post-AHF Follow-up

OTHER

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

Other: AVATAR-SC

Standard Care + AVATAR-SC Monitoring

OTHER

Patients receiving monthly therapy in accordance with standard clinical practice will undergo remote monitoring via the AVATAR-SC platform.

Other: AVATAR-SC; Drug: Levosimendan

Interventions

AVATAR-SC OTHER

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

AVATAR_SC Post-AHF Follow-up; Standard Care + AVATAR-SC Monitoring

Levosimendan DRUG

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. .

Standard Care + AVATAR-SC Monitoring

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

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.

Sponsors & Collaborators

• Niguarda Hospital: lead

Study Sites (1)

ASST Grande Ospedale Metropolitano Niguarda

Milan, Ita, 202162, Italy

Location

MeSH Terms

Conditions

Heart Failure

Interventions

Simendan

Condition Hierarchy (Ancestors)

Heart Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Hydrazones; Hydrazines; Organic Chemicals; Pyridazines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Alessandro Verde, MD

CONTACT

+39026444; alessandro.verde@ospedaleniguarda.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Feasability study

Study Record Dates

• First Submitted: April 14, 2026
• First Posted: June 24, 2026
• Study Start: June 30, 2026
• Primary Completion (Estimated): May 15, 2027
• Study Completion (Estimated): May 15, 2028
• Last Updated: June 24, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)