AI-Based Monitoring System for Chronic Heart Failure With Advanced Wearable and Mini-Invasive Dev… (NCT06909682) | Clinical Trial Compass
RecruitingNot Applicable
AI-Based Monitoring System for Chronic Heart Failure With Advanced Wearable and Mini-Invasive Devices
Italy205 participantsStarted 2025-08-01
Plain-language 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) 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.
Who can participate
Age range
19 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change in Hospital Admissions with AI-Based Remote Monitoring