Heart FailureAVATAR-HFNCT07664748
Artificial Voice Analysis and Telemonitoring for Heart Failure. A Feasibility Study
A study testing AVATAR-SC and Levosimendan in people with Heart Failure, run by Niguarda Hospital at 1 site in Italy.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Heart Failure
- What is being tested?
- AVATAR-SC and Levosimendan
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 30 Oct 2026to 15 May 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
ASST Grande Ospedale Metropolitano Niguarda
Milan, Ita, 202162
Alessandro Verde, MD, +39026444 ext. 7791, aòessandro.verde@ospedaleniguardaa.it
About this study
Official title: AVATAR-HF (Artificial Voice Analysis and Telemonitoring for Heart Failure): Studio di fattibilità Sull'Uso Dell'Analisi Vocale Basata su Intelligenza Artificiale Per il Telemonitoraggio Dei Pazienti Con Insufficienza Cardiaca.
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.
Read more
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.
Read the detailed description
Heart Failure (HF) is a leading cause of hospitalization and mortality among the elderly, characterized by high readmission rates and a significant impact on the National Health Service. Despite guideline recommendations, only a minority of patients receive timely post-discharge follow-up, contributing to clinical deterioration and rising healthcare costs. Existing remote monitoring systems have shown mixed results, primarily due to poor patient adherence, data interpretation challenges, and high costs. While vocal and linguistic analysis supported by Artificial Intelligence (AI) algorithms has shown promise for the early identification of heart failure, its practical application in home monitoring has yet to be systematically evaluated.
AVATAR-SC proposes an accessible, non-invasive platform based on advanced AI technologies. It integrates vocal biomarkers, clinical data, and Patient-Reported Outcome Measures (PROMs) to enhance home monitoring and support a more proactive management of heart failure patients.
Study Population: 60 patients with Heart Failure (HF), including 30 patients discharged following hospitalization for acute heart failure and 30 patients receiving monthly Levosimendan therapy in a Day Hospital setting.
Study Objectives: Although AI-supported vocal and linguistic analysis shows significant potential for the early detection of clinical deterioration in HF patients, there is a lack of data regarding feasibility, acceptability, adherence, integration into care pathways, and data quality within a real-world home monitoring context. A feasibility study is therefore necessary to:i) evaluate patients' ability to use AVATAR-SC independently;ii) estimate adherence to daily vocal data collection;iii) verify the technical performance of the platform;iv) define operational metrics (time, resources, completion rates);v) identify barriers and facilitators in preparation for a large-scale clinical trial.The study does not involve the use of AI systems as clinical tools, nor their application for the automated assessment of an individual patient's health status.Nature and extent of benefits and risks associated with study participation: Potential benefits include more regular symptom monitoring and increased support in disease management. Risks are minimal and primarily concern the use of technology and the processing of personal data.
Intervention: Interactions via digital avatar ≥ 2 times/week, collection of short voice clips, and essential PROMs (Patient-Reported Outcome Measures). No alerts will be generated, and there will be no influence on the patient's clinical pathway.
- Conditions
- Heart Failure
- Being tested
- AVATAR-SC, Levosimendan
- Keywords
- Vocal biomarkers, Artificial Intelligence, Feasibility Study, Neuropsychological and Psychological Test
- Medical subject headings
- Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
AVATAR-SCOther
Patients discharged following hospitalization for acute heart failure will be enrolled in this study arm and will utilize AVATAR_SC for periodic monitoring
LevosimendanDrug
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. .
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: AVATAR-SC; Drug: Levosimendan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasability of the AVATAR-SC System in Heart Failure patients
≥80% of patients compleating 75% of scheduled interaction
Measured: Through study completion, an average of 3 months per patients
Secondary outcomes (9)
Change in Perceived Quality of Life (QoL)
Outcome Measures. A clinical improvement defined as at least a 10% increase in perceived quality of life scores, as measured by standardized Patient-Reported Outcome Measures (KCCQ, EQ-5D).
Measured: Through study completion, an average of 3 months per patients
Change in Vocal Biomarkers Score
Exploratory offline analysis to evaluate the statistical consistency between vocal patterns and clinical parameters. Quantitative metrics including accuracy, precision, recall, and F1-score will be used for descriptive purposes only. This analysis is purely exploratory, without the definition of clinical thresholds, individual classification, or operational use of the results
Measured: Through study completion, an average of 3 months per patients
New York Heart Association (NYHA) Functional Class of Heart Failure
Clinical assessment performed by the physician to evaluate the patient's overall heart failure severity and functional limitations based on cardiac symptoms. The evaluation is performed using the New York Heart Association (NYHA) classification, which categorizes patients into one of four classes based on their limitations during physical activit (class I to IV) . Higher classes indicate greater severity of heart failure and worse functional status.
Measured: Through study completion, an average of 3 months per patients
Change in Montreal Cognitive Assessment (MoCA) Score
The MoCA is a screening instrument for cognitive impairment. It assesses different cognitive domains: attention and concentration, executive functions, memory, language, visuoconstructional skills, conceptual thinking, calculations, and orientation. The total score is the sum of all item scores. The scale ranges from 0 to 30, where a score higher than 26 .
Measured: Through study completion, an average of 3 months per patients ]
Change in Frontal Assessment Battery (FAB) Score
The FAB is a brief tool to assess executive functions. It consists of six subtests (similarities, lexical fluency, motor series, conflicting instructions, go-no-go, and grasping behavior). Total scores range from 0 to 18, where higher scores indicate better executive function.
Measured: Through study completion, an average of 3 months per patients
Change in Patient Health Questionnaire-9 (PHQ-9) Score
The PHQ-9 is a self-report tool used to screen for and monitor the severity of depression. It consists of 9 items based on the DSM-IV criteria for depression. Each item is scored on a scale from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 27, where higher scores indicate greater severity of depressive symptoms (e.g., 5-9: mild; 10-14: moderate; 15-19: moderately severe; 20-27: severe).
Measured: Through study completion, an average of 3 months per patients
Change in Trail Making Test (TMT)
Psychological Well-being as Patient Health Questionnaire-9 (PHQ-9) for depressive symptoms and Generalized Anxiety Disorder-7 (GAD-7) for anxiety levels.
Measured: Through study completion, an average of 3 months per patients
Change in Generalized Anxiety Disorder-7 (GAD-7) Score
The GAD-7 is a self-report scale for screening and severity measuring of generalized anxiety disorder. It consists of 7 items, each scored from 0 (not at all) to 3 (nearly every day). The total score ranges from 0 to 21, where higher scores indicate a higher level of anxiety (e.g., 5-9: mild; 10-14: moderate; 15-21: severe).The SDMT is used to assess psychomotor speed and attention. Patients are given a key matching symbols to numbers and must fill in the correct numbers for a series of symbols within 90 seconds. The score is the number of correct substitutions. Scores typically range from 0 to 110. A higher score indicates better cognitive processing speed and attention.
Measured: Through study completion, an average of 3 months per patients
Change in Symbol Digit Modalities Test (SDMT) Score
The SDMT is used to assess psychomotor speed and attention. Patients are given a key matching symbols to numbers and must fill in the correct numbers for a series of symbols within 90 seconds. The score is the number of correct substitutions. Scores typically range from 0 to 110. A higher score indicates better cognitive processing speed and attention.
Measured: Through study completion, an average of 3 months per patients
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Jun 2026
- Study start30 Oct 2026 (estimated)
- Primary completion15 May 2027 (estimated)
- Study completion15 May 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Heart FailureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Feasability study
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Niguarda Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07664748
- Sponsor's protocol ID
- 7005
- Other IDs
- InnovaWalfare 2025-0158
- Acronym
- AVATAR-HF
- Status last verified
- Oct 2026
- First submitted
- 14 Apr 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual Participant Data (IPD) will not be made publicly available to ensure strict compliance with EU Regulation 2016/679 (GDPR) and to protect patient privacy regarding sensitive vocal recordings. All collected data, including audio tracks and clinical features, are processed in a pseudo-anonymous form using non-reversible alphanumeric codes. The link log connecting these codes to patients' identities is stored exclusively at the coordinating center (ASST GOM Niguarda) and is not accessible to other partners or third parties.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- AVATAR-HF (Artificial Voice Analysis and Telemonitoring for Heart Failure): Studio di fattibilità Sull'Uso Dell'Analisi Vocale Basata su Intelligenza Artificiale Per il Telemonitoraggio Dei Pazienti Con Insufficienza Cardiaca.
- ClinicalTrials.gov ID
- NCT07664748
- Acronym / sponsor ID
- AVATAR-HF / 7005
- Conditions
- Heart Failure
- Keywords
- Vocal biomarkers, Artificial Intelligence, Feasibility Study, Neuropsychological and Psychological Test
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Niguarda HospitalUniversity, hospital or other
- Study start
- 30 Oct 2026 (estimated)
- Primary completion
- 15 May 2027 (estimated)
- Study completion
- 15 May 2028 (estimated)
- First posted
- 24 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Heart Failure (HF) is a leading cause of hospitalization and mortality among the elderly, characterized by high readmission rates and a significant impact on the National Health Service. Despite guideline recommendations, only a minority of patients receive timely post-discharge follow-up, contributing to clinical deterioration and rising healthcare costs. Existing remote monitoring systems have shown mixed results, primarily due to poor patient adherence, data interpretation challenges, and high costs. While vocal and linguistic analysis supported by Artificial Intelligence (AI) algorithms has shown promise for the early identification of heart failure, its practical application in home monitoring has yet to be systematically evaluated.
AVATAR-SC proposes an accessible, non-invasive platform based on advanced AI technologies. It integrates vocal biomarkers, clinical data, and Patient-Reported Outcome Measures (PROMs) to enhance home monitoring and support a more proactive management of heart failure patients.
Study Population: 60 patients with Heart Failure (HF), including 30 patients discharged following hospitalization for acute heart failure and 30 patients receiving monthly Levosimendan therapy in a Day Hospital setting.
Study Objectives: Although AI-supported vocal and linguistic analysis shows significant potential for the early detection of clinical deterioration in HF patients, there is a lack of data regarding feasibility, acceptability, adherence, integration into care pathways, and data quality within a real-world home monitoring context. A feasibility study is therefore necessary to:i) evaluate patients' ability to use AVATAR-SC independently;ii) estimate adherence to daily vocal data collection;iii) verify the technical performance of the platform;iv) define operational metrics (time, resources, completion rates);v) identify barriers and facilitators in preparation for a large-scale clinical trial.The study does not involve the use of AI systems as clinical tools, nor their application for the automated assessment of an individual patient's health status.Nature and extent of benefits and risks associated with study participation: Potential benefits include more regular symptom monitoring and increased support in disease management. Risks are minimal and primarily concern the use of technology and the processing of personal data.
Intervention: Interactions via digital avatar ≥ 2 times/week, collection of short voice clips, and essential PROMs (Patient-Reported Outcome Measures). No alerts will be generated, and there will be no influence on the patient's clinical pathway.
Study design
- Primary purpose
- Health services research
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Feasability study
| Arm | Type | Receives |
|---|---|---|
| AVATAR_SC Post-AHF Follow-up | Other | Other: AVATAR-SCPatients discharged following hospitalization for acute heart failure will be enrolled in this study arm and will utilize AVATAR_SC for periodic monitoring |
| Standard Care + AVATAR-SC Monitoring | Other | Other: AVATAR-SC, Drug: LevosimendanPatients receiving monthly therapy in accordance with standard clinical practice will undergo remote monitoring via the AVATAR-SC platform. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| AVATAR-SCPatients 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 Post-AHF Follow-up, Standard Care + AVATAR-SC Monitoring |
| LevosimendanPatients 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. . | Drug | Standard Care + AVATAR-SC Monitoring |
Primary outcome
Feasability of the AVATAR-SC System in Heart Failure patients
Time frame: Through study completion, an average of 3 months per patients
≥80% of patients compleating 75% of scheduled interaction
9 secondary outcomes
Change in Perceived Quality of Life (QoL)
Time frame: Through study completion, an average of 3 months per patients
Change in Vocal Biomarkers Score
Time frame: Through study completion, an average of 3 months per patients
New York Heart Association (NYHA) Functional Class of Heart Failure
Time frame: Through study completion, an average of 3 months per patients
Change in Montreal Cognitive Assessment (MoCA) Score
Time frame: Through study completion, an average of 3 months per patients ]
Change in Frontal Assessment Battery (FAB) Score
Time frame: Through study completion, an average of 3 months per patients
Change in Patient Health Questionnaire-9 (PHQ-9) Score
Time frame: Through study completion, an average of 3 months per patients
Change in Trail Making Test (TMT)
Time frame: Through study completion, an average of 3 months per patients
Change in Generalized Anxiety Disorder-7 (GAD-7) Score
Time frame: Through study completion, an average of 3 months per patients
Change in Symbol Digit Modalities Test (SDMT) Score
Time frame: Through study completion, an average of 3 months per patients
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Individual participant dataSharing planned: No. Individual Participant Data (IPD) will not be made publicly available to ensure strict compliance with EU Regulation 2016/679 (GDPR) and to protect patient privacy regarding sensitive vocal recordings. All collected data, including audio tracks and clinical features, are processed in a pseudo-anonymous form using non-reversible alphanumeric codes. The link log connecting these codes to patients' identities is stored exclusively at the coordinating center (ASST GOM Niguarda) and is not accessible to other partners or third parties.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing AVATAR-SC and Levosimendan in people with Heart Failure, run by Niguarda Hospital at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Alessandro Verde, MD (+39026444 ext. 7791, alessandro.verde@ospedaleniguarda.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasability of the AVATAR-SC System in Heart Failure patients (time frame: Through study completion, an average of 3 months per patients). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026.