AI-guided wearable monitoring for people with chronic heart failure
Compares AI remote monitoring with a wearable device to standard follow-up in heart failure.
Plain-language title generated from the registry record
Registry title: AI-Based Monitoring System for Chronic Heart Failure With Advanced Wearable and Mini-Invasive Devices
Key facts
- Where
- Salerno, ItalySee the site
Where in Italy
- Hospital University San Giovanni di Dio and Ruggi d'AragonaSalerno, ItalyTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- University of Salerno
- Trial code
- NCT06909682
- Record updated
- 11 March 2026
- Original description
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).Read full original descriptionShow less
Smart Monitoring and Analysis System Based on Artificial Intelligence for Patients With Chronic Heart Failure Using Advanced Mini-Invasive and Wearable Medical Devices
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).
The main questions it aims to answer are:
* Can continuous remote monitoring reduce hospital admissions (emergency visits and hospitalizations) by 20% compared to standard care? * 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.
Participants will:
* Wear the EmbracePlus (Empatica Inc.) device continuously for six months (intervention group only). * Have their biometric data (SpO₂, HRV, EDA, respiratory rate, temperature, sleep quality) monitored remotely. * Receive automated alerts and teleconsultations if abnormal physiological changes are detected. * Attend scheduled follow-up visits (remote and in-person) for clinical evaluation and treatment adjustments.
The study aims to provide real-world evidence on whether integrating wearable health technology with AI analytics can enhance CHF management and improve patient outcomes.
Inclusion: Age ≥ 18 years (adults of any sex); Confirmed diagnosis of chronic heart failure (CHF) for at least 6 months prior to screening; Stable on optimized heart failure therapy for at least one month before enrollment; Any left ventricular ejection fraction (LVEF) classification, including:; Heart Failure with Reduced Ejection Fraction (HFrEF); Heart Failure with Mid-Range Ejection Fraction (HFmrEF); Heart Failure with Preserved Ejection Fraction (HFpEF); NYHA Functional Class I, II, or III; 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; Ability to provide written informed consent or availability of a legally authorized representative Exclusion Criteria; NYHA Functional Class IV or anticipated heart transplant or ventricular assist device (VAD) implantation within 6 months of screening; Severe renal impairment (eGFR < 30 mL/min/1.73 m²) or dialysis dependence; Terminal comorbidities (e.g., advanced cancer, end-stage pulmonary disease) significantly limiting life expectancy; Pregnancy; Presence of skin conditions or allergies preventing prolonged use of a wearable device; Inability to comply with study procedures (e.g., cognitive impairment, significant psychiatric disorders).