Actively Recruiting
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
Eligibility Criteria
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
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
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
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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