Status:
NOT_YET_RECRUITING
AI-Based Monitoring System for Chronic Heart Failure With Advanced Wearable and Mini-Invasive Devices
Lead Sponsor:
University of Salerno
Conditions:
Chronic Heart Failure
Cardiovascular Diseases
Eligibility:
All Genders
19+ years
Brief 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) w...
Detailed Description
Chronic Heart Failure (CHF) is a multifactorial syndrome characterized by high rates of hospitalization, morbidity, and mortality. Despite advances in pharmacological and device-based therapies, early...
Eligibility Criteria
Inclusion
- 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)
Exclusion
Key Trial Info
Start Date :
August 1 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
February 2 2027
Estimated Enrollment :
205 Patients enrolled
Trial Details
Trial ID
NCT06909682
Start Date
August 1 2025
End Date
February 2 2027
Last Update
April 3 2025
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