National Academy of Clinical Biochemistry Laboratory Medicine practice guidelines: Clinical utilization of cardiac biomarker testing in heart failure.
W H Wilson Tang, Gary S Francis, David A Morrow...
https://pubmed.ncbi.nlm.nih.gov/17630410Actively Recruiting
Age: 19Years +
All Genders
ID06909682
Smart Monitoring and Analysis System Based on Artificial Intelligence for Patients With Chronic Heart Failure Using Advanced Mini-Invasive and Wearable Medical Devices
Led by University of Salerno · Updated on 2026-03-11
205
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
1
2
3
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
Trial Site Locations
Total: 1 location
1
Hospital University San Giovanni di Dio and Ruggi d'Aragona
Salerno, Italy
Actively Recruiting
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Research Team
A
Alessia Bramanti, Electronic Engineering
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
2
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