Status:
RECRUITING
WeRoaM: Wearable Remote Monitoring in Heart Failure
Lead Sponsor:
University of Alberta
Collaborating Sponsors:
Canadian Institutes of Health Research (CIHR)
Conditions:
Heart Failure
Eligibility:
All Genders
8-18 years
Brief 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...
Detailed Description
Remote physiologic monitoring (RPM) refers to utilizing non-invasive medical devices to obtain physiologic data, such as pulse oximetry, blood pressure, weight, and electrocardiography at home. Recent...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
February 24 2025
Trial Type :
OBSERVATIONAL
Allocation :
ESTIMATED
End Date :
December 31 2028
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT06969560
Start Date
February 24 2025
End Date
December 31 2028
Last Update
May 14 2025
Active Locations (4)
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1
Stollery Children's Hospital
Edmonton, Alberta, Canada, T6G 2B7
2
BC Children's Hospital
Vancouver, British Columbia, Canada, V6H 3N1
3
The Hospital for Sick Children
Toronto, Ontario, Canada, M5G 1E8
4
CHU Sainte-Justine
Montreal, Quebec, Canada, QC H3T