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

Launched by UNIVERSITY OF SALERNO · Apr 1, 2025

Keywords

ClinConnect Summary

This clinical trial is looking at how an AI-based monitoring system can help manage chronic heart failure (CHF) in adults. Researchers want to see if using a wearable device called EmbracePlus can reduce the number of hospital visits by 20% compared to regular care. They will track important health information like heart rate, oxygen levels, and sleep quality from participants wearing the device for six months. Participants will also receive alerts and remote consultations if any concerning changes are detected in their health data.

To join the study, participants need to be at least 18 years old and have been diagnosed with chronic heart failure for at least six months. They should also be stable on their heart failure medications. Key exclusions include those with very severe heart failure, certain serious medical conditions, or pregnancy. Throughout the study, participants will have regular check-ins, both online and in-person, to ensure they are managing their heart failure effectively. The goal is to find out if this new technology can improve health outcomes and quality of life for people living with chronic heart failure.

Gender

ALL

Eligibility criteria

• • 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)