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Can a wristband keep heart failure patients out of hospital?

NCT ID NCT07835490

Disease control Sponsor: Medical University of Lodz 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Sep 23, 2026 · Last updated Sep 25, 2026 · Updated 2 times

Summary

Researchers are testing whether a wearable wristband can help people with chronic heart failure. The wristband measures physical activity, blood oxygen and heart rate every 15 minutes and sends the data to a secure database. Half of the 60 participants wear the wristband for 3 months alongside regular cardiology care, while the other half receive regular care alone. The team compares the two groups to see whether remote monitoring is linked to fewer hospital stays or deaths from worsening heart failure.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
a telemonitoring wristband that tracks physical activity, blood oxygen and heart rate
What this could lead to
If it works, remote wristband monitoring could give cardiology teams an early warning when a heart failure patient is deteriorating, possibly preventing hospital stays.
What could go wrong
This is a small study of 60 people, so any benefit may be modest or not hold up in larger groups. Wristbands can also give false readings or miss problems, and some patients may find them inconvenient to wear.

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

60 people

The number who actually took part.

Started

Feb 2023

Expected to finish

Dec 2028

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.

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: * provided written informed consent prior to any study specific procedures; * males and females aged \>18 years old at the time of consent; * documented diagnosis of HFrEF prior to enrollment and optimally treated with pharmacological and/or device therapy; * left ventricular ejection fraction ≤40% in a transthoracic echocardiogram from the last 12 months before recruitment; * NYHA class II-III. Exclusion Criteria: * acute or decompensated heart failure; * the primary cause of heart failure in the form of active myocarditis, constrictive pericarditis or a valvular heart disease that has not been treated by interventional or surgical means, as defined by the ESC guidelines; * myocardial infarction, unstable angina, stroke or transient ischemic attack, coronary revascularization by percutaneous coronary intervention or coronary artery bypass graft, valve replacement surgery or ICD/CRT implantation within 4 weeks prior to study enrollment; * planned coronary revascularization by percutaneous coronary intervention or coronary artery bypass graft; * planned valve replacement surgery; * status after heart transplantation; * symptomatic bradycardia or third-degree atrioventricular block without a pacemaker; * a severe non-cardiovascular disease with a life expectancy of less than 1 year, or a patient condition precluding the performance of the procedures specified in the study protocol; * diagnosis of malignancy at the time of screening; * history of an allergic reaction to materials contained in the wristband.

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Conditions

The condition(s) this trial relates to.

heart failure systolic heart failure

As listed by the trial registrant

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

Heart failure Heart failure with reduced ejection fraction (hfref)

Contacts and locations

Locations

  • 2nd Department of Cardiology, Medical University of Lodz, Poland

    Lodz, 92-213, Poland

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