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Functional assessment 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

Observational University of Texas Southwestern Medical Center · NCT04583878

This study is trying to understand how deep vein blood clots affect the physical abilities of children aged 8 to 21 by comparing them to other kids with limited activity and healthy kids.

Quick facts

Study typeObservational
Enrollment125 (estimated)
Ages8 Years to 21 Years
SexAll
SponsorUniversity of Texas Southwestern Medical Center Academic / other
Locations14 sites (Little Rock, Arkansas and 13 other locations)
Trial IDNCT04583878 on ClinicalTrials.gov

What this trial studies

This observational study aims to characterize children aged 8 to 21 years who have experienced their first episode of deep venous thrombosis or pulmonary embolism. Participants will undergo a series of tests including cardiopulmonary exercise testing, pulmonary function testing, cardiac MRI, and blood biomarker analysis over a 3-day visit. The study will enroll subjects from multiple sites and will compare them to control groups of children with physical activity restrictions and healthy children. Data collected will help understand the functional impacts of these conditions in children.

Who should consider this trial

Good fit: Ideal candidates are children aged 8 to 21 years with a confirmed diagnosis of acute pulmonary embolism or deep venous thrombosis.

Not a fit: Patients with congenital heart disease, chronic kidney disease, or chronic inflammatory disorders may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved understanding and management of chronic venous thromboembolic disease in children.

How similar studies have performed: While there have been studies on venous thromboembolic disease in adults, this specific approach in children is relatively novel and has not been extensively tested.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* Ages 8 to ≤ 21 years
* Participant must be able to speak and understand English
* Be willing to participate and able to comply with the study protocol
* For participants with PE: Children with acute, radiologically confirmed pulmonary embolism (PE) with our without DVT
* For control group: Cohort 1: Children who are prescribed physical activity restrictions for 2 up to 12 weeks following any minor outpatient surgery or, minor injury (surgery or injury is referred to as "diagnosis" hereafter) Cohort 2: Children who are not prescribed physical activity restrictions and are otherwise considered to be healthy.

Exclusion Criteria:

* Congenital heart disease with abnormal pulmonary circulation or with in-situ pulmonary artery thrombosis
* Chronic kidney disease
* Chronic inflammatory or an autoimmune disorder (such as systemic lupus erythematosus, juvenile rheumatoid disorder, inflammatory bowel disease, and sickle cell disease)
* A metabolic or endocrinological disorder such as diabetes mellitus or thyroid disorder
* History of or active cancer
* Pregnant
* Musculoskeletal limitations to exercise expected to be present uptil 4 months post-diagnosis
* Weight ≥ 300 lbs
* Contraindications to magnetic resonance imaging
* Frequent severe exacerbations of asthma defined by two or more bursts of systemic glucocorticoids (more than three days each) in the previous year or at least one hospitalization, intensive care unit stay or mechanical ventilation in the previous year. Patients should also be excluded if there are daily symptoms of asthma requiring daily use of short-acting bronchodilators such as albuterol or levalbuterol administration. The use of controller medications such as daily inhaled corticosteroids for mild persistent asthma is not exclusionary.
* Has any other medical condition, which in the opinion of the investigator may potentially compromise the safety or compliance of the patient or may preclude the patient's successful completion of the clinical study

Additional exclusion criteria for participants with PE:

* Prior history of DVT or PE (upper extremity, cerebral sinus venous thrombosis and abdominal thromboses encountered as a neonate are not exclusion criteria)
* Lack of anticoagulant treatment for the acute VTE due to contraindications

Where this trial is running

Little Rock, Arkansas and 13 other locations

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Deep Venous ThrombosisPulmonary Embolism
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.