The Functional Characterization of Venous Thromboembolic Disease (FUVID) study: rationale, design, and methods of a prospective, observational, multicenter study to evaluate mechanisms of exercise intolerance and dyspnea following pediatric pulmonary embolism

The Functional Characterization of Venous Thromboembolic Disease (FUVID) study: rationale, design, and methods of a prospective, observational, multicenter study to evaluate mechanisms of exercise intolerance and dyspnea following pediatric pulmonary embolism

Background: To date, the focus of investigation in pediatric pulmonary embolism (PE) has been on PE recurrence and anticoagulant-related bleeding. While highly relevant, these outcomes do not fully capture functional limitations and the psychological impact that comprises post-PE syndrome. Objective...

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Main Authors: Ayesha Zia, Michael D. Nelson, Jimin Ren, Song Zhang, Robert F. Mattrey, Brian L. Han, Tarique Hussain, Joshua S. Greer, Manal Al-Qahtani, Kendra Malone, Sonja E. Stutzman, Deseray V. Sida, Sharon Primeaux, Marcela D. Torres, Clay T. Cohen, Shelley Crary, Jonathan Bernstein, Hilary B. Whitworth, Riten Kumar, Kisha A. Beg, Osman Khan, Madhvi Rajpurkar, Kerry Hege, Beverly A. Schaefer, Gary M. Woods, Lauren E. Amos, Marisol Betensky, Rukhmi V. Bhat, Sarah O’ Brien, Julie Jaffray, Rohit Jesudas, Martha M. Pacheco, Cristina Tarango, Angela C. Weyand, Hope P. Wilson, Jessica Garcia, Mary P. Dang, Ruchika Sharma, Neil A. Goldenberg, Frederikus A. Klok, Christoph Male, Benjamin Levine, Bryce N. Balmain, Tony G. Babb, Leah M. Adix, BS, Steven Ambrusko, MD, Shames Alaesa, BSc, Kristen Bradley, BSN, RN, Brain R. Branchford, MD, Katie Carlberg, MD, James D. Cooper, MD, Susan A. Corley, MPH, Marissa Di Miero, MBA, Anna Eidenberger, Edith Freyer, DNP, Kevin Guerrero, Arun Gurunathan, MD, Brandon Hathorn, BSc, Muhammad Khan, Shawn D. Lade, BS, Deanna M. Maida, MD, Marie Martinelli, MD, Corey Mozingo, BS, Raksa Moran, RN, Sharon A. Primeaux, MS, Leslie Raffini, MD, MSCE, Rhea Robinson, BSN, Cynthia Sabo, MSN, Negin Saleh, Anjali A. Sharathkumar, MBBS, MD, MS, Rachel Simon, DNP, APRN, CPNP-PC, Lakshmi Srivaths, MD, MacKenzie Tasset, BS, Katrina Williams, BS, Rebekah Summerall Woodward, MPH, Neil A. Goldenberg, MD, PhD, Frederikus A. Klok, MD, PhD, Christoph Male, MS, MSc, Tony G. Babb, PhD, Madhvi Rajpurkar, MD, Song Zhang, PhD
Format: Article
Language:English
Published: Elsevier 2025-01-01
Series:Research and Practice in Thrombosis and Haemostasis
Subjects:
children
pediatrics
pulmonary embolism
post–pulmonary embolism syndrome
venous thromboembolism
Online Access:http://www.sciencedirect.com/science/article/pii/S2475037924003649
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Summary:Background: To date, the focus of investigation in pediatric pulmonary embolism (PE) has been on PE recurrence and anticoagulant-related bleeding. While highly relevant, these outcomes do not fully capture functional limitations and the psychological impact that comprises post-PE syndrome. Objectives: The primary objective of the Functional Characterization of Venous Thromboembolic Disease (FUVID) study was to investigate mechanisms of post-PE syndrome in children. Methods: The ongoing FUVID study will prospectively enroll and systematically follow, over 12 months and with standardized pulmonary, cardiac, and muscle testing, a multicenter prospective cohort of 80 pediatric patients with first-episode PE without comorbidities. FUVID has 2 coprimary outcomes: exercise intolerance and exertional dyspnea. Exercise intolerance will be defined objectively as a percent predicted peak oxygen uptake based on ideal body weight or milliliters per minute per kilogram of lean body mass during cardiopulmonary exercise testing. Dyspnea will be objectively quantified using Borg questionnaires and defined as a mean difference of >1 at the end of the warm-up and submaximal work rates during exercise testing, simulating conditions during daily life that induce dyspnea. Pertinent secondary outcomes include anxiety, depression, and quality of life. Conclusion: The FUVID study will investigate the relationship between symptoms (exercise intolerance and exertional dyspnea) and multiple mechanisms—hemodynamic, ventilatory, or peripheral/muscle—within the same patient at rest, submaximal exercise (simulating activities of daily living), and maximal exercise using objective measures. It will provide new evidence for selecting patients for long-term follow-up, including psychological sequelae, after PE, the modalities this follow-up should include, and the findings interpreted as indicating functional limitations after PE.
ISSN:2475-0379

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