Haihao Sun, Norman Stockbridge, D. Dunbar Ivy, Jennifer Clark, Angela Bates, Stephanie S. Handler, Usha S. Krishnan, MAry P. Mullen, Delphine Yung, Rachel K. Hopper, Nidhy P. Varghese, Catherine M. Avitabile, Jeff Fineman, Eric D. Austin, Grace Freire
U.S. Food and Drug Administration. University of Colorado School of Medicine. Stollery Children’s Hospital and University of Alberta. Medical College of Wisconsin. New York Presbyterian Hospital and Columbia University Irving Medical Center. Boston Children’s Hospital and Harvard Medical School. University of Washington School of Medicine and Seattle Children’s Hospital. Stanford University School of Medicine and Lucile Packard Children’s Hospital. Baylor College of Medicine and Texas Children’s Hospital.Children’s Hospital of Philadelphia and University of Pennsylvania. University of California San Francisco Benioff Children’s Hospital. Vanderbilt University. Johns Hopkins All Children’s Hospital.
United States and Canada
Journal of Pediatrics
J Pediatr 2024;
DOI: 10.1016/j.jpeds.2024.114383
Abstract
Objectives: To investigate the feasibility of using actigraphy to measure physical activity (pA) and heart rate variability (HRV) as study endpoints in pediatric pulmonary arterial hypertension (PAH) and to compare their performance to six-minute-walk distance (6MWD), a common primary endpoint used in PAH clinical trials in adults and children who can walk and understand the test process.
Study design: We conducted a prospective, multicenter, non-interventional study in pediatric PAH patients and healthy children. Actiheart™ and Fitbit Charge 2™ recorded pA and heart rate (HR) data. HRV was defined as standard deviation of daily HR. Actigraphy pA and HRV and 6MWD from the same subjects were analyzed to compare children with PAH with controls, and Panama functional classification (FC) III versus II. Power/sample size simulations were conducted to detect hypothetical treatment effect equivalent to differences seen between FC III and FC II.
Results: We enrolled 116 children; 90 and 98 adhered with Actiheart and Fitbit, respectively. Actigraphy daily pA was ∼36% lower (P<0.05) and daily HRV was ∼18% lower (P<0.05) in children with PAH (n=62) than healthy controls (n=54). Daily pA and daily HRV trended ∼17% lower in FC III than FC II, whereas 6MWD showed little difference. Simulation at 80% power showed that pA required 175 subjects per group and HRV required 40 per group to detect the difference/effect, whereas 6MWD required over our maximum sample size of 200.
Conclusions: Actigraphy is a feasible measure in pediatric PAH. Compared with 6MWD, pA and HRV may be more sensitive in differentiating Panama FC III from II. HRV may improve actigraphy’s utility in pediatric PAH.
Category
Symptoms and Findings Associated with Pulmonary Vascular Disease
Diagnostic Testing for Pulmonary Vascular Disease. Non-invasive Testing
Age Focus: Pediatric Pulmonary Vascular Disease
Fresh or Filed Publication: Fresh (PHresh). Less than 1-2 years since publication
Article Access
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