AI-Based Monitoring System for Chronic Heart Failure With Advanced Wearable and Mini-Invasive Devices

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

Inclusion Criteria

* 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)

Conditions6

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