NCT06909682Recruiting
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
Source: ClinicalTrials.gov · Last updated 11 Mar 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 205 (estimated)
- First submitted
- 14 Mar 2025
- Start date
- 1 Aug 2025
- Primary completion date
- 1 Aug 2026
- Lead sponsor
- University of Salerno
- Diseases
- Heart failure
- NCT number
- NCT06909682
What you commit to
- Study type: Observational
- Planned participants: 205
- From 1 Aug 2025 to the primary completion date, 1 Aug 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Who the study is looking for
- 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)
Age in the registry: 19 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Hospital University San Giovanni di Dio and Ruggi d'Aragona Coordinator of this site? Confirm its status | Salerno | Italy | Recruiting |
Related publications
- Artificial intelligence-based remote monitoring for chronic heart failure: design and rationale of the SMART-CARE study.Front Digit Health · 2025 · PMID 41451381
This page is information, not medical advice. Discuss any trial with your doctor.