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Smart Monitoring and Analysis System Based on Artificial Intelligence for Patients With Chronic Heart Failure Using Advanced Mini-Invasive and Wearable Medical Devices

Status: Recruiting
Location: See location...
Intervention Type: Device, Other
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 19
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Italy
Hospital University San Giovanni di Dio and Ruggi d'Aragona
RECRUITING
Salerno
Contact Information
Primary
Alessia Bramanti, Electronic Engineering
abramanti@unisa.it
+393483809181
Time Frame
Start Date: 2025-08-01
Estimated Completion Date: 2027-02-02
Participants
Target number of participants: 205
Treatments
Intervention Group (Device Group - AI-Based Remote Monitoring)
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.
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.
Sponsors
Leads: University of Salerno

This content was sourced from clinicaltrials.gov