[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100586000":3},{"organization":4,"armGroups":7,"interventions":19,"overallOfficials":10,"centralContacts":28,"locations":34,"responsibleParty":50,"collaborators":10,"id":54,"slug":55,"hasResults":56,"nctId":57,"briefTitle":58,"officialTitle":59,"acronym":60,"eligibilityCriteria":61,"healthyVolunteers":56,"sex":62,"minAge":63,"maxAge":10,"enrollmentInfo":64,"targetDuration":10,"studyType":67,"phases":10,"briefSummary":68,"conditions":69,"keywords":75,"overallStatus":37,"whyStopped":10,"lastUpdateSubmitDate":89,"lastUpdatePostDateStruct":90,"startDateStruct":93,"completionDateStruct":95,"leadSponsor":97,"locationsCount":98},{"fullName":5,"class":6},"University of Salerno","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"Intervention Group (Device Group - AI-Based Remote Monitoring)",null,"Participants in this group will wear the EmbracePlus mini-invasive device for continuous remote monitoring over a six-month period. The device tracks key physiological parameters, including oxygen saturation (SpO₂), heart rate variability (HRV), electrodermal activity (EDA), temperature, respiratory rate, and sleep quality. Data is transmitted to a centralized AI-driven platform, which analyzes trends and detects early signs of heart failure worsening. If significant abnormalities are identified, the system triggers automated alerts, prompting teleconsultations or in-person evaluations as needed to ensure timely clinical intervention.",[13],"Device: Intervention Group (Device Group - AI-Based Remote Monitoring)",{"label":15,"type":10,"description":16,"interventionNames":17},"Control Group (Non-Device Group - Standard Clinical Follow-Up)","Participants in this group will receive standard chronic heart failure (CHF) management according to current clinical guidelines. Their follow-up will consist of scheduled in-person visits every three months, during which they will undergo routine laboratory tests (including BNP, NT-proBNP, renal function, and electrolytes), as well as echocardiography and ECG evaluations. Treatment adjustments will be made based on clinical assessments and reported symptoms.",[18],"Other: Standard Clinical Follow-Up",[20,24],{"type":21,"name":9,"description":22,"armGroupLabels":23,"otherNames":10},"DEVICE","This intervention utilizes a mini-invasive wearable device for continuous remote monitoring of chronic heart failure (CHF) patients. Unlike traditional telemonitoring, it integrates AI-driven predictive analytics to track oxygen saturation (SpO₂), heart rate variability (HRV), electrodermal activity (EDA), temperature, respiratory rate, and sleep quality in real time. The system generates automated alerts for healthcare providers, enabling early detection of CHF exacerbation and proactive intervention through teleconsultations, medication adjustments, or in-person evaluations. Data is securely transmitted to a cloud-based platform, allowing continuous risk assessment and personalized care adjustments. This approach aims to reduce unnecessary hospitalizations, enhance patient monitoring, and optimize heart failure management through advanced AI-based digital health technology.",[9],{"type":6,"name":25,"description":26,"armGroupLabels":27,"otherNames":10},"Standard Clinical Follow-Up","Participants in this group will receive standard chronic heart failure (CHF) management according to current clinical guidelines. Their follow-up will consist of scheduled in-person visits every three months, during which they will undergo routine laboratory tests (including BNP, NT-proBNP, renal function, and electrolytes), as well as echocardiography and ECG evaluations. Treatment adjustments will be made based on clinical assessments and reported symptoms. Unlike the intervention group, these participants will not use a wearable device, and their condition will be monitored exclusively through traditional hospital visits and self-reported health status.",[15],[29],{"name":30,"role":31,"phone":32,"phoneExt":10,"email":33},"Alessia Bramanti, Electronic Engineering","CONTACT","+393483809181","abramanti@unisa.it",[35],{"facility":36,"status":37,"city":38,"state":10,"zip":10,"country":39,"countryCode":40,"cosmosGeoPoint":41,"geoPoint":46,"contacts":47},"Hospital University San Giovanni di Dio and Ruggi d'Aragona","RECRUITING","Salerno","Italy","IT",{"type":42,"coordinates":43},"Point",[44,45],14.79328,40.67545,{"lat":45,"lon":44},[48],{"name":49,"role":31,"phone":10,"phoneExt":10,"email":10},"Alessia Bramanti, Associate Professor",{"type":51,"investigatorFullName":52,"investigatorTitle":53,"investigatorAffiliation":5,"oldNameTitle":10,"oldOrganization":10},"PRINCIPAL_INVESTIGATOR","Alessia Bramanti","Associate Professor","100586000","ai-based-monitoring-system-for-chronic-heart-failure-with-advanced-wearable-and-mini-invasive-devices-100586000",false,"NCT06909682","AI-Based Monitoring System for Chronic Heart Failure With Advanced Wearable and Mini-Invasive Devices","Smart Monitoring and Analysis System Based on Artificial Intelligence for Patients With Chronic Heart Failure Using Advanced Mini-Invasive and Wearable Medical Devices","SMART-CARE","Inclusion Criteria\n\n* Age ≥ 18 years (adults of any sex)\n* Confirmed diagnosis of chronic heart failure (CHF) for at least 6 months prior to screening\n* Stable on optimized heart failure therapy for at least one month before enrollment\n* Any left ventricular ejection fraction (LVEF) classification, including:\n\n  * Heart Failure with Reduced Ejection Fraction (HFrEF)\n  * Heart Failure with Mid-Range Ejection Fraction (HFmrEF)\n  * Heart Failure with Preserved Ejection Fraction (HFpEF)\n* NYHA Functional Class I, II, or III\n* History of at least one hospital admission or outpatient visit in the past 12 months requiring intravenous (IV) diuretics, vasodilators, or inotropes for CHF exacerbation\n* Ability to provide written informed consent or availability of a legally authorized representative Exclusion Criteria\n* NYHA Functional Class IV or anticipated heart transplant or ventricular assist device (VAD) implantation within 6 months of screening\n* Severe renal impairment (eGFR \\\u003C 30 mL\u002Fmin\u002F1.73 m²) or dialysis dependence\n* Terminal comorbidities (e.g., advanced cancer, end-stage pulmonary disease) significantly limiting life expectancy\n* Pregnancy\n* Presence of skin conditions or allergies preventing prolonged use of a wearable device\n* Inability to comply with study procedures (e.g., cognitive impairment, significant psychiatric disorders)","ALL","19 Years",{"count":65,"type":66},205,"ESTIMATED","OBSERVATIONAL","The goal of this observational, multicenter study is to evaluate whether AI-driven remote monitoring using a mini-invasive wearable device can improve clinical outcomes in adult patients (≥18 years) with chronic heart failure (CHF).\n\nThe main questions it aims to answer are:\n\n* Can continuous remote monitoring reduce hospital admissions (emergency visits and hospitalizations) by 20% compared to standard care?\n* Does wearable-based remote monitoring improve functional, biochemical, and instrumental parameters in CHF patients? Researchers will compare patients using the wearable device (intervention group) to those receiving standard clinical follow-up (control group) to assess whether AI-driven monitoring leads to fewer hospitalizations, better disease management, and improved quality of life.\n\nParticipants will:\n\n* Wear the EmbracePlus (Empatica Inc.) device continuously for six months (intervention group only).\n* Have their biometric data (SpO₂, HRV, EDA, respiratory rate, temperature, sleep quality) monitored remotely.\n* Receive automated alerts and teleconsultations if abnormal physiological changes are detected.\n* Attend scheduled follow-up visits (remote and in-person) for clinical evaluation and treatment adjustments.\n\nThe study aims to provide real-world evidence on whether integrating wearable health technology with AI analytics can enhance CHF management and improve patient outcomes.",[70,71,72,73,74],"Chronic Heart Failure","Cardiovascular Diseases","Heart Failure With Reduced Ejection Fraction (HFrEF)","Heart Failure With Preserved Ejection Fraction (HFPEF)","Congestive Heart Failure Chronic",[76,77,78,79,80,81,82,83,84,85,86,87,88],"Wearable Medical Devices","Remote Patient Monitoring","Artificial Intelligence in Cardiology","Smart Wearables for Healthcare","Observational Study in Heart Failure","AI-Based Predictive Modeling","Telemedicine in Heart Failure","Non-Invasive Health Monitoring","Personalized Medicine for CHF","Quality of Life Improvement in Heart Failure","Heart Failure Readmission Prevention","Telehealth in Chronic Disease Management","Digital Health Solutions for Heart Disease","2026-03-09",{"date":91,"type":92},"2026-03-11","ACTUAL",{"date":94,"type":92},"2025-08-01",{"date":96,"type":66},"2027-02-02",{"name":5,"class":6},1]