AI-driven wearable monitoring for chronic heart failure

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

SMART-CARE is a prospective, multicenter observational comparison of two parallel cohorts: patients managed with standard clinical follow-up versus patients wearing a CE‑certified EmbracePlus device with AI analytics for six months. The wearable continuously captures physiological signals (SpO2, HRV, electrodermal activity, respiratory rate, skin temperature, actigraphy-based sleep and fatigue metrics) and transmits them to a central platform for automated analysis. Investigators will compare rates of emergency visits and hospitalizations and changes in functional, biochemical, and instrumental parameters between groups. The design aims to determine whether AI-driven continuous monitoring can detect deterioration earlier and guide timely care compared with routine follow-up.

Why it matters

Who can join: the full rules

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)

Where it's running

• Hospital University San Giovanni di Dio and Ruggi d'Aragona
  Salerno, Italy Recruiting

Study contacts

• Study coordinator: Alessia Bramanti, Electronic Engineering
• Email: abramanti@unisa.it
• Phone: +393483809181

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.