An interventional study of AVATAR-SC and Levosimendan in Heart Failure, sponsored by Niguarda Hospital. Recruiting at 1 site in Italy. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-13.
Sponsored by Niguarda Hospital · Not applicable, Interventional, and Health services research
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.
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.
6,331 studies on the registry are indexed under Heart Failure; 1,396 are open to participants now.
This study's planned enrollment of 60 is below the median of 76 across 4,049 interventional studies indexed under Heart Failure.
Browse Heart Failure studies →Niguarda Hospital is the lead sponsor of 68 studies on the registry; 29 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
NYHA class (heart failure)
The New York Heart Association’s four classes of how much heart failure limits physical activity.
Studies set their own limit — many outside heart failure leave out class III–IV, while heart failure studies may ask for a particular class. Check the class this study names.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Life expectancy
The study doctor’s estimate of how long someone is likely to live. Criteria use it so that people can stay in the study long enough for it to answer its question.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
Patients receiving monthly therapy in accordance with standard clinical practice will undergo remote monitoring via the AVATAR-SC platform.
Other: AVATAR-SC · Drug: Levosimendan
Patients discharged following hospitalization for acute heart failure will be enrolled in this study arm and will utilize AVATAR\_SC for periodic monitoring
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. .
Feasability of the AVATAR-SC System in Heart Failure patients
≥80% of patients compleating 75% of scheduled interaction
Time frame: Through study completion, an average of 3 months per patients
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).
Time frame: 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
Time frame: 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.
Time frame: 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 .
Time frame: 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.
Time frame: 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).
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: Through study completion, an average of 3 months per patients
Plan to share: 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.
No publications or documents are linked to this record.
Start is estimated for Oct 2026; primary completion for May 2027, 6 months later.
Of 1,118 non-industry interventional studies with no phase under Heart Failure, half reached primary completion within 29 months of starting (the median), counting those still running; a quarter within 16 and three quarters within 50. This study's planned 6 months is below that.
Counting every sponsor, half of 1,354 studies reached it within 31 months; a quarter within 16 and three quarters within 52.
Start moved once since we started tracking on Sep 25, 2026: Jun 2026 → Oct 2026, on Oct 13, 2026.
Earlier changes are on the record history on ClinicalTrials.gov ↗
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Niguarda Hospital