Actively Recruiting
AI-Based Monitoring System for Chronic Heart Failure With Advanced Wearable and Mini-Invasive Devices
Led by University of Salerno · Updated on 2026-03-11
205
Participants Needed
1
Research Sites
78 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
AI-Based Monitoring System for Chronic Heart Failure With Advanced Wearable and Mini-Invasive Devices
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Age 2424 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), and 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 diuretics, vasodilators, or inotropes for CHF exacerbation
- Ability to provide written informed consent or availability of a legally authorized representative
You will not qualify if you...
- 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 m) or dialysis dependence
- Terminal comorbidities significantly limiting life expectancy (e.g., advanced cancer, end-stage pulmonary disease)
- Pregnancy
- Presence of skin conditions or allergies preventing prolonged use of a wearable device
- Inability to comply with study procedures due to cognitive impairment or significant psychiatric disorders
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
Hospital University San Giovanni di Dio and Ruggi d'Aragona
Salerno, Italy
Actively Recruiting
Research Team
A
Alessia Bramanti, Electronic Engineering
CONTACT
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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