WeRoaM: Wearable Remote Monitoring in Heart Failure
Recruiting · NCT06969560 · Observational (researchers observe without assigning treatment) · Lead sponsor: University of Alberta
View the official record on ClinicalTrials.gov →Interventions studied
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.
Who can take part
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.
Where it is running
4 locations listed.
- Stollery Children's Hospital - Edmonton, Alberta, Canada
- BC Children's Hospital - Vancouver, British Columbia, Canada
- The Hospital for Sick Children - Toronto, Ontario, Canada
- CHU Sainte-Justine - Montreal, Quebec, Canada