NCT04583878

FUVID Study: Functional Characterization of Children With Chronic Venous Thromboembolic Disease

FUVID Study: A Multi-center, Prospective Study Evaluating Exercise Intolerance and Dyspnea on Exertion in Patients Following First-episode Deep Venous Thrombosis and Pulmonary Embolism

• Status: Active Not Recruiting
• Phase: —
• Study type: Observational
• Enrollment: 115 (actual)
• Sponsor: University of Texas Southwestern Medical Center · Academic / Other
• Sex: All
• Age: 8 Years – 21 Years
• Healthy volunteers: Accepted

Summary

This is a multi-center prospective cohort study of patients with first-episode deep venous thrombosis and pulmonary embolism.

Detailed description

Subjects will be identified from the clinical setting and approached to participate in this observational study where participants will be enrolled at 3 different sites and referred from several more sites and have: cardiopulmonary exercise testing and pulmonary function testing at The Institute of Exercise and Environmental Medicine (IEEM), UTSW Exercise Facility, Cardiac MRI and MRI for pulmonary perfusion at Children's Medical Center and MR Spectroscopy and MR for Muscle Perfusion at the Advanced Imaging Research Center (AIRC) performed in Dallas over a 3 day research visit at week 12 and Month 12. Blood is collected for biomarkers at these visits and multiple questionnaires are completed by participants.

Conditions

• Deep Venous Thrombosis
• Pulmonary Embolism

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Blood draw (Visit 1)	Labs will be drawn at Visit 1, also referred to as screening (within 60 days of diagnosis) with the standard of care labs drawn.
DIAGNOSTIC_TEST	Blood draw (Visits 2 and 3)	Labs will be drawn at Visit 2 (12 weeks post-diagnosis with a range of 10-16 weeks) and Visit 3 (12 months ± 30 days) for research purposes only and will be collected at Children's Medical Center and processed at UT Southwestern Medical Center.

Timeline

• Start date: 2020-12-22
• Primary completion: 2026-06-01
• Completion: 2026-12-01
• First posted: 2020-10-12
• Last updated: 2026-02-02

Locations

14 sites across 1 country: United States