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Smart watch study aims to cut heart failure hospitalizations by 20%

NCT ID NCT06909682

Knowledge-focused Sponsor: University of Salerno Source: ClinicalTrials.gov ↗

What the study statuses mean

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Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study is testing whether a special wearable device, combined with artificial intelligence, can help people with chronic heart failure avoid hospital visits. About 205 adults will wear the device for six months while their health data is monitored remotely. The goal is to see if early alerts and check-ins can reduce emergency room visits and hospital stays compared to standard care.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 205 people

The number the study aims to enrol. It can still change while the study runs.

Started

Aug 2025

Expected to finish

Feb 2027

An estimate. End dates often move.

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

The SMART-CARE study will enroll adult patients (≥18 years) with chronic heart failure (CHF) from specialized cardiology and geriatrics clinics. Participants will have NYHA Class I-III heart failure and varying left ventricular ejection fraction (LVEF) classifications (HFrEF, HFmrEF, HFpEF). Patients will be recruited from tertiary hospitals and research centers, including: AOU "San Giovanni di Dio Ruggi d'Aragona" (Cardiology \& Cardiac Rehab) IRCCS Neurolesi "Bonino Pulejo" (Cardiology Unit) IRCCS Fondazione Casa Sollievo della Sofferenza (Geriatrics Unit) The study will compare: Intervention Group: AI-based remote monitoring with a wearable device. Control Group: Standard CHF management with routine follow-ups. Participants will be clinically stable but at risk of hospitalization, and those with NYHA Class IV, severe renal impairment, or terminal illnesses will be excluded.

Ages

19 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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)

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Conditions

The condition(s) this trial relates to.

cardiovascular disorder congestive heart failure diastolic heart failure systolic heart failure

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Cardiovascular diseases Chronic heart failure Congestive heart failure chronic Heart failure with preserved ejection fraction (hfpef Heart failure with reduced ejection fraction (hfref)

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    1 site. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Hospital University San Giovanni di Dio and Ruggi d'Aragona

    RECRUITING

    Salerno, Italy

More trials for these conditions

Other studies related to the condition(s) this trial covers.