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

Recruitingn/aAges 19 Years - anyAllUniversity of Salerno
NCT06909682 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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 (

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📋 Eligibility rules (as published)
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)
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What it tests

  • Intervention Group (Device Group - AI-Based Remote Monitoring)
  • Standard Clinical Follow-Up
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Where

1 site
Hospital University San Giovanni di Dio and Ruggi d'Aragona
Salerno, Italy
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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