RecruitingNCT06909682

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

Sponsor

University of Salerno

Enrollment

205 participants

Start Date

Aug 1, 2025

Study Type

OBSERVATIONAL

Conditions

Cardiovascular Diseases Heart Failure With Reduced Ejection Fraction (HFrEF)Chronic Heart Failure

Summary

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.

Eligibility

Min Age: 19 Years

Plain Language Summary

Simplified for easier understanding

This study is testing an AI-powered monitoring system using wearable devices and minimally invasive sensors to track people with chronic heart failure more closely at home, with the goal of detecting worsening symptoms earlier and preventing hospitalizations. **You may be eligible if...** - You are 18 or older - You have been diagnosed with chronic heart failure for at least 6 months - Your heart failure treatment has been stable for at least 1 month - You have had at least one hospitalization or clinic visit in the past 12 months requiring IV fluids, diuretics, or heart medications for a heart failure flare-up - You are in NYHA functional class I, II, or III (not the most severe stage) **You may NOT be eligible if...** - Your heart failure is unstable or very newly diagnosed - You are unable to use or wear monitoring devices - You have conditions that would interfere with wearable or sensor-based monitoring Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEIntervention Group (Device Group - AI-Based Remote Monitoring)

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.

OTHERStandard 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.