There's No Place Like Home…Feasibility of Remote Physiological Monitoring in Childhood Heart Failure

Status: Recruiting
Location: See all (4) locations...
Intervention Type: Device
Study Type: Observational
SUMMARY

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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 8
Maximum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Canada
Stollery Children's Hospital
RECRUITING
Edmonton
CHU Sainte-Justine
NOT_YET_RECRUITING
Montreal
The Hospital for Sick Children
NOT_YET_RECRUITING
Toronto
BC Children's Hospital
NOT_YET_RECRUITING
Vancouver
Contact Information
Primary
Jennifer L Conway, MD, MSc
jennifer.conway2@ahs.ca
780-407-4848
Backup
Tara L Pidborochynski, MSc
tara.pidborochynski@ahs.ca
780-407-1899
Time Frame
Start Date: 2025-02-24
Estimated Completion Date: 2028-12-31
Participants
Target number of participants: 100
Treatments
paediatric outpatients (8 to 18 years old) with diagnosis of cardiomyopathy
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.~Patients will participate in a remote physiologic monitoring program using bluetooth enabled devices for 12 weeks. Devices as part of the study intervention include: Skiin chest band and ECG device; blood pressure monitor; pulse oximeter; weight scale.
Related Therapeutic Areas
Sponsors
Collaborators: Canadian Institutes of Health Research (CIHR)
Leads: University of Alberta

This content was sourced from clinicaltrials.gov