Actively Recruiting

Age: 8Years - 18Years
All Genders
NCT06969560

WeRoaM: Wearable Remote Monitoring in Heart Failure

Led by University of Alberta · Updated on 2026-05-11

100

Participants Needed

4

Research Sites

200 weeks

Total Duration

On this page

Sponsors

U

University of Alberta

Lead Sponsor

C

Canadian Institutes of Health Research (CIHR)

Collaborating Sponsor

AI-Summary

What this Trial Is About

Remote physiologic monitoring (RPM) of heart failure (HF) patients with a virtual platform is well established in adult care. However, this technology remains untested in pediatrics and care continues to rely on a hospital-based model which presents challenges in providing equitable access to care for those with lower socio-economic status or living remotely. Telemonitoring technology tailored for children with machine-based algorithms to predict deterioration is needed to facilitate the equitable provision of safe, home-based care, especially in vulnerable populations. This study will enroll 100 pediatric outpatients with or at risk of deteriorating HF from 4 tertiary pediatric heart failure care centres in Canada. We will use a wearable Bluetooth enabled textile (Skiin device), developed by Myant Inc (Toronto, ON), that can monitor heart rate, heart rhythm, respiratory rate and activity, together with additional home-based monitoring of blood pressure (BP), oxygen saturations and weight. The smart textile will be paired to an RPM platform, SphygmoTM (mmHG Inc). The goal of this project is to assess the feasibility and acceptability of RPM in pediatrics and validate a RPM-based risk prediction model for pediatric HF patients.

CONDITIONS

Official Title

WeRoaM: Wearable Remote Monitoring in Heart Failure

Who Can Participate

Age: 8Years - 18Years
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients aged 8 to 18 years who are outpatients at enrollment
  • Chest size of at least 69.85 cm in circumference under the pectoral muscles
  • Patients at risk of heart failure or with American Heart Association Stage B-D Heart Failure
  • Heart failure causes include congenital cardiac malformations, idiopathic cardiomyopathy, familial or genetic cardiomyopathy, myocarditis with persistent dysfunction, neuromuscular disorders, metabolic or mitochondrial disorders, acquired causes (chemotherapy, infection, rheumatic, nutritional), ischemic causes (e.g., Kawasaki disease, post-operative heart failure), left ventricular non-compaction, restrictive cardiomyopathy, and hypertrophic cardiomyopathy with systolic or diastolic dysfunction
Not Eligible

You will not qualify if you...

  • Patients within 3 months after surgery
  • Patients supported by a ventricular assist device at study start
  • Inability to use technology due to physical or cognitive impairments in patient or caregiver
  • Non-English speaking patients
  • Patients with an implantable cardiac defibrillator or pacemaker
  • Patients whose chest size does not fit available Skiin device sizes

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 4 locations

1

Stollery Children's Hospital

Edmonton, Alberta, Canada, T6G 2B7

Actively Recruiting

2

BC Children's Hospital

Vancouver, British Columbia, Canada, V6H 3N1

Not Yet Recruiting

3

The Hospital for Sick Children

Toronto, Ontario, Canada, M5G 1E8

Not Yet Recruiting

4

CHU Sainte-Justine

Montreal, Quebec, Canada, QC H3T

Not Yet Recruiting

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Research Team

J

Jennifer L Conway, MD, MSc

CONTACT

T

Tara L Pidborochynski, MSc

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

1

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