Wearable remote monitoring for pediatric heart failure patients

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study focuses on the use of wearable remote physiologic monitoring (RPM) technology to track the health of pediatric patients with heart failure or those at risk of developing it. By enrolling 100 outpatients aged 8-18 from four tertiary pediatric heart failure centers in Canada, the study aims to utilize a Bluetooth-enabled textile device to monitor vital signs such as heart rate, respiratory rate, and blood pressure. The goal is to improve home-based care and reduce reliance on hospital visits, particularly for vulnerable populations. The study will also explore the integration of machine learning algorithms to predict health deterioration based on collected data.

Why it matters

Who can join: the full rules

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's running

• Stollery Children's Hospital
  Edmonton, Alberta, Canada Recruiting
• BC Children's Hospital
  Vancouver, British Columbia, Canada Not yet recruiting
• The Hospital for Sick Children
  Toronto, Ontario, Canada Not yet recruiting
• CHU Sainte-Justine
  Montreal, Quebec, Canada Not yet recruiting

Study contacts

• Principal investigator: Jennifer L Conway, MD, MSc — University of Alberta/Stollery Children's Hospital
• Study coordinator: Jennifer L Conway, MD, MSc
• Email: jennifer.conway2@ahs.ca
• Phone: 780-407-4848

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• Using Apple Watch data to predict heart failure outcomes

  This study is testing if data from Apple Watches can help predict heart failure problems and the chances of needing to go back to the hospital for patients with heart failure.

  Recruiting University Medical Center Goettingen · Goettigen, Lower Saxony · NCT06819618

• Comparing Aortix Device to Diuretics for Acute Heart Failure

  This study is testing whether the Aortix device can help people with acute heart failure who aren't responding to diuretics feel better compared to standard treatment.

  Recruiting at 33 sites Procyrion · Phoenix, Arizona and 49 other locations · NCT05677100

• Myocardial Energetics Across Cardiovascular Disease Spectrum Using 31P-MRS

  Researchers are testing whether phosphorus-31 magnetic resonance spectroscopy (31P-MRS) can map heart energy metabolism across healthy people and patients with various heart conditions.

  Recruiting Chinese Academy of Medical Sciences, Fuwai Hospital · Beijing · NCT07912086

• Tailored digital support to cut sedentary time in long-term cardiac rehab

  In adults in a long-term cardiac rehabilitation program, this study tests whether a personalized behavioural program with digital tools can reduce daily sitting time.

  Recruiting University of Lisbon · Lisbon, Lisbon District · NCT07910812

• NT-proBNP–guided heart failure screening for people 65+ in rural China

  This study tests whether using NT-proBNP blood tests to guide heart failure screening in adults 65 and older in rural China can find unrecognized heart problems more effectively than symptom-based screening.

  Recruiting Jiangsu Taizhou People's Hospital · Nanjing · NCT07885488

• Voice-based detection of heart failure deterioration using Noah Labs Vox

  This study tests whether a voice-analysis app can flag worsening heart failure in adults by comparing its alerts to standard weight-based monitoring.

  Recruiting Noah Labs · Boston, Massachusetts · NCT07870395

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.