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Smart wearable alerts aim to cut heart failure hospitalizations

NCT ID NCT04502563

Disease control Sponsor: VA Office of Research and Development Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 tested whether a small wearable sensor, combined with a smart computer program, could detect early signs of worsening heart failure and alert doctors to adjust treatment before a hospital stay is needed. Researchers enrolled 176 veterans with heart failure and randomly assigned half to receive this monitoring. The goal was to see if this approach could reduce hospital admissions, shorten stays, and improve quality of life.

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.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

176 people

The number who actually took part.

Started

Apr 2021

Finished

Oct 2024

Lead sponsor

A government agency

The lead sponsor is a US federal agency other than the NIH.

Who can take part

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

Ages

18 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: * Subject must be 18 years old or older * New York Heart Association Functional Classification Class II-IV, documented in site's medical record system. * Subject able and willing to sign Informed Consent Document, and if participating in a patient interview, able to comprehend and agree with items listed in the VA Consent Cover Letter. * Subject willing and able to perform all study related procedures. Exclusion Criteria: * Expected Left Ventricular Assist Device implantation or heart transplantation in the next 30 days. * Skin damage or significant arthritis, preventing wearing of device. * Uncontrolled seizures or other neurological disorders leading to excessive abnormal movements or tremors in the upper body. * Pregnant women or those who are currently nursing. * Visual/cognitive impairment that as judged by the investigator does not allow the subject to independently follow rules and procedures of the protocol.

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Conditions

The condition(s) this trial relates to.

heart failure

As listed by the trial registrant

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

Heart failure

Contacts and locations

Locations

  • Hunter Holmes McGuire VA Medical Center, Richmond, VA

    Richmond, Virginia, 23249-0001, United States

  • North Florida/South Georgia Veterans Health System, Gainesville, FL

    Gainesville, Florida, 32608-1135, United States

  • VA Palo Alto Health Care System, Palo Alto, CA

    Palo Alto, California, 94304-1207, United States

  • VA Salt Lake City Health Care System, Salt Lake City, UT

    Salt Lake City, Utah, 84148-0001, United States

More trials for these conditions

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