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Wearable tech could let kids with heart failure recover at home

NCT ID NCT06969560

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

What the study statuses mean

This study's is highlighted.

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study is testing whether wearable devices and home monitors can safely track the health of children with heart failure. One hundred kids aged 8 to 18 from four Canadian hospitals will use a chest band, blood pressure cuff, pulse oximeter, and scale for 12 weeks. The goal is to see if this approach is practical and acceptable, and to develop a risk prediction model that could one day allow more care at home instead of in the hospital.

What this could mean

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

Active substance
Remote physiologic monitoring (wearable chest band, blood pressure monitor, pulse oximeter, weight scale)
What this could lead to
If successful, this could pave the way for safe, home-based monitoring of children with heart failure, reducing hospital stays and improving access to care.
What could go wrong
This is an early feasibility study with only 100 participants, so results may not apply to all children. The technology may be difficult to use or fail to detect worsening heart failure reliably.

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 100 people

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

Started

Feb 2025

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.

Who is studied

This study will enroll 100 paediatric outpatients (8 to 18 years old) with diagnosis of cardiomyopathy (with systolic or diastolic dysfunction), subjects with congenital heart disease with biventricular or univentricular physiology plus systemic ventricular dysfunction from 4 tertiary heart failure care centres.

Ages

8 to 18 years

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: * Patients from 8-18 years of age who are outpatients at time of study enrollment. * Patients with a chest size of at least 69.85 cm in perimeter/circumference (as measured under the pectoral muscles) * Patients at-risk for heart failure and with American Heart Association (AHA) Stage B-D Heart Failure will be included in this study irrespective of heart failure medication use. * HF etiologies include: congenital cardiac malformation with systemic ventricular systolic dysfunction, idiopathic cardiomyopathy, familial/inherited and/or genetic cardiomyopathy, history of myocarditis with persistent ventricular dysfunction, neuromuscular disorder, inborn error of metabolism, mitochondrial disorder, acquired (chemotherapy, iatrogenic, infection, rheumatic, or nutritional), ischemic (e.g., Kawasaki disease and post-operative HF), and left ventricular non-compaction, restrictive cardiomyopathy and HCM with systolic or diastolic dysfunction. Exclusion Criteria: * Patients within 3 months of a surgery. * Patients supported by ventricular assist device at study onset. * Inability to use technology due to physical or cognitive impairment in the patient or caregiver. * Non-English speaking. * Patients who have an implantable cardiac defibrillator or pacemaker * Patients whose chest size is too large or small to fit available sizes of the Skiin device.

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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

How to take part

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

  1. The places running it

    4 sites. 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

  • BC Children's Hospital

    NOT_YET_RECRUITING

    Vancouver, British Columbia, V6H 3N1, Canada

  • CHU Sainte-Justine

    NOT_YET_RECRUITING

    Montreal, Quebec, QC H3T, Canada

  • Stollery Children's Hospital

    RECRUITING

    Edmonton, Alberta, T6G 2B7, Canada

  • The Hospital for Sick Children

    NOT_YET_RECRUITING

    Toronto, Ontario, M5G 1E8, Canada

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