NCT06969560Recruiting
WeRoaM: Wearable Remote Monitoring in Heart Failure
There's No Place Like Home…Feasibility of Remote Physiological Monitoring in Childhood Heart Failure
Source: ClinicalTrials.gov · Last updated 11 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 100 (estimated)
- First submitted
- 22 Apr 2025
- Start date
- Feb 2025
- Primary completion date
- Dec 2026
- Lead sponsor
- University of Alberta
- Diseases
- Heart failure
- NCT number
- NCT06969560
What you commit to
- Study type: Observational
- Planned participants: 100
- From Feb 2025 to the primary completion date, Dec 2026
- 4 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients within 3 months of a surgery.
Other illness
- Inability to use technology due to physical or cognitive impairment in the patient or caregiver.
- Patients who have an implantable cardiac defibrillator or pacemaker
Other
- Patients supported by ventricular assist device at study onset.
- Non-English speaking.
- Patients whose chest size is too large or small to fit available sizes of the Skiin device.
Who the study is looking for
- 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.
Age in the registry: 8 years to 18 years · Sex: All · Does not accept healthy volunteers
Sites (4)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Stollery Children'S Hospital Coordinator of this site? Confirm its status | Edmonton | Canada | Recruiting |
| CHU Sainte-Justine Coordinator of this site? Confirm its status | Montreal | Canada | Not yet recruiting |
| The Hospital for Sick Children Coordinator of this site? Confirm its status | Toronto | Canada | Not yet recruiting |
| BC Children ' s Hospital Coordinator of this site? Confirm its status | Vancouver | Canada | Not yet recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.