What is this study trying to find out about chronic heart failure?

This study is investigating whether using an AI-driven wearable device for continuous remote monitoring can reduce hospital admissions and improve health outcomes in adults with chronic heart failure. It compares standard care to care supported by this advanced technology to see if it helps manage the condition better. The research is sponsored by the University of Salerno and aims to improve patient quality of life.

Who may be eligible for this chronic heart failure clinical trial?

Adults aged 18 years or older with a confirmed chronic heart failure diagnosis for at least six months may be eligible. Participants should be stable on heart failure therapy, with NYHA Functional Class I, II, or III, and have a recent history of hospital visits for heart failure. The trial is open to all genders. Please review eligibility criteria for more details.

Is there any cost to participate in this chronic heart failure clinical trial?

Study-related care, including the use of the wearable device and all trial visits, is provided at no cost. However, personal expenses such as travel or accommodation may vary and are not guaranteed to be covered. Participants should consider these potential costs when deciding to join the trial.

Actively Recruiting

Age: 19Years +

All Genders

ID06909682

AI-Enhanced Continuous Remote Monitoring Using Wearable Devices to Improve Outcomes in Adults with Chronic Heart Failure

Led by University of Salerno · Updated on 2026-03-11

205

Participants Needed

Research Sites

26 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating whether continuous remote monitoring using an AI-driven, mini-invasive wearable device can improve clinical outcomes for adults aged 18 years and older with chronic heart failure CHF. The study compares patients using the EmbracePlus device to those receiving standard clinical care to see if this technology reduces hospital admissions by 20% and improves functional, biochemical, and instrumental health parameters. This observational, multicenter study seeks to provide real-world evidence on integrating wearable technology with AI to enhance CHF management and patient quality of life. Participants in the intervention group will wear the EmbracePlus device continuously for six months, which tracks key physiological parameters like oxygen saturation, heart rate variability, electrodermal activity, temperature, respiratory rate, and sleep quality. Data is transmitted to a centralized AI platform that analyzes trends and generates alerts for teleconsultations or in-person visits if abnormalities are detected. The control group will receive standard CHF management, including scheduled in-person visits every three months with lab tests, echocardiography, and ECG evaluations. Treatment adjustments will be made based on clinical assessments in both groups. During the study, participants will attend regular follow-up visits, either remotely or in person, for clinical evaluations and treatment adjustments. Researchers will monitor hospital admissions over six months as the primary outcome and assess secondary outcomes such as quality of life, therapy-related adverse effects, biochemical markers, and cardiac function through various tests at baseline, three months, and six months. Data privacy is maintained by pseudonymizing all collected information, and patients provide informed consent before enrollment.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 19Years +

All Genders

Eligibility Criteria

You may qualify if you...

Age 18 years or older
Confirmed diagnosis of chronic heart failure 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 classification (HFrEF, HFmrEF, 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 diuretics, vasodilators, or inotropes for CHF exacerbation
Ability to provide written informed consent or have a legally authorized representative

You will not qualify if you...

NYHA Functional Class IV or planned heart transplant or ventricular assist device implantation within 6 months
Severe renal impairment (eGFR below 30 mL/min/1.73 m²) or dialysis dependence
Terminal comorbidities significantly limiting life expectancy (e.g., advanced cancer, end-stage lung disease)
Pregnancy
Skin conditions or allergies preventing prolonged wearable device use
Inability to comply with study procedures due to cognitive or psychiatric issues

Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Monitoring

Duration - 6 months

Participants are observed either through continuous remote monitoring using a wearable device integrated with AI analytics or through standard clinical follow-up visits every three months. The wearable device collects physiological data in real time to detect early signs of heart failure worsening, triggering teleconsultations or in-person evaluations as needed. Standard follow-up includes routine laboratory tests, echocardiography, and ECG evaluations to assess heart failure status.

Continuous remote monitoring for the device group; scheduled in-person visits every 3 months for the standard care group