Skip to main content
OpenTrials
Active, Not Recruiting

NCT Number: NCT04583878

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

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

Active, Not Recruiting

This study is active but is not currently recruiting participants.

Key information

Age range

8 year–21 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Arkansas Childrens Research Institute (ACRI), Little Rock, Arkansas, United States

Loading trial locations.

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blood draw (Visit 1)

Diagnostic Test

Labs will be drawn at Visit 1, also referred to as screening (within 60 days of diagnosis) with the standard of care labs drawn.

Blood draw (Visits 2 and 3)

Diagnostic Test

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.

Primary outcomes

  1. Change in exercise capacity

    Time frame: 3 months and 12 months post-diagnosis

    Measured objectively by peak oxygen uptake (VO2) as a percent predicted based on ml/min/kg of lean body mass during cardiopulmonary exercise testing (CPET)

  2. Change in dyspnea on exertion (DOE)

    Time frame: 3 months and 12 months post-diagnosis

    measured using Borg questionnaire and defined as a mean difference of > 1 between those with and without exercise intolerance at the end of the warm-up and submaximal work rates during CPET

Secondary outcomes

  1. Change in cardiac maladaptation

    Time frame: 3 months and 12 months post-diagnosis

    Measured as ventriculo-arterial coupling ratio in response to exercise (change in Ea/Emax from rest to peak intensity exercise) during exercise cardiac magnetic resonance imaging (MRI)

  2. Change in pulmonary/ventilatory limitations

    Time frame: 3 months and 12 months post-diagnosis

    Measured as VE/VCO2 in participants with and without exercise intolerance during cardiopulmonary testing

  3. Change in muscle metabolic aberrations

    Time frame: 3 months and 12 months post-diagnosis

    Measured by % phosphocreatine (PCr) depletion (Δ %PCr) during exercise using 31P magnetic resonance spectroscopy on 7 Tesla in participants with and without exercise intolerance

  4. Change in pulmonary vascular obstruction score in participants with and without exercise intolerance (Quantitative assessment)

    Time frame: At diagnosis, 3 months and 12 months post-diagnosis

    Quantitative Assessment: Measured using Qanadli Index scale (range 0-40; 0=minimum score and 40=maximum score) at pulmonary embolism diagnosis and 3 months post-diagnosis.

  5. Change in pulmonary vascular obstruction score in participants with and without exercise intolerance (Qualitative assessment)

    Time frame: At diagnosis, 3 months and 12 months post-diagnosis

    Qualitative Assessment: Measured using pulmonary perfusion maps at diagnosis, 3 and 12 months post-diagnosis. Since qualitative, there are no minimum or maximum values.

  6. Change in calf muscle perfusion and venous flow in participants with and without exercise intolerance and between affected and non-affected extremity

    Time frame: 3 months and 12 months post-diagnosis

    Measured using extremity arterial spin labelling on 7 Tesla MRI

  7. Change in dyspnea ratings using Dalhousie Pictorial Scale

    Time frame: 3 months and 12 months post-diagnosis

    Measured at rest, fatigue, and post-exercise in participants with and without exercise intolerance

    Dalhousie Pictorial Scale measuring Dyspnea and Perceived Exertion (minimum score=4; maximum score=28; higher score means worse dyspnea)

  8. Change in dyspnea ratings using Borg Dyspnea Scale

    Time frame: 3 months and 12 months post-diagnosis

    Measured at rest, fatigue, and post-exercise in participants with and without exercise intolerance

    Borg Dyspnea Scale (minimum score=0; maximum score=10; higher score means worse dyspnea)

  9. Change in dyspnea ratings using Dyspnoea-12 Scale

    Time frame: 3 months and 12 months post-diagnosis

    Measured at rest, fatigue, and post-exercise in participants with and without exercise intolerance

    Dyspnoea-12 Scale (minimum score=0; maximum score=36; higher score means worse dyspnea)

  10. Change in dyspnea ratings using Modified Medical Research Council Dyspnea Scale

    Time frame: 3 months and 12 months post-diagnosis

    Measured at rest, fatigue, and post-exercise in participants with and without exercise intolerance

    Modified Medical Research Council Dyspnea Scale (minimum score=0; maximum score=4; higher score means worse dyspnea)

  11. Change in inflammatory cytokine biomarker - High-sensitivity CRP

    Time frame: At diagnosis, 3 months and 12 months post-diagnosis

    Measure inflammatory cytokine biomarker high-sensitivity CRP (unit of measure: mg/L) in participants with and without exercise intolerance

  12. Change in inflammatory cytokine biomarkers - IL-6 and TNF

    Time frame: At diagnosis, 3 months and 12 months post-diagnosis

    Measure inflammatory cytokine biomarkers IL-6 and TNF-α (unit of measure: pg/mL) in participants with and without exercise intolerance

  13. Change in coagulation biomarker - D-dimer

    Time frame: At diagnosis, 3 months and 12 months post-diagnosis

    Measure coagulation biomarker D-dimer (unit of measure: ng/mL) in participants with and without exercise intolerance

  14. Change in coagulation biomarker - Thrombin generation

    Time frame: At diagnosis, 3 months and 12 months post-diagnosis

    Measure coagulation biomarker thrombin generation (unit of measure: nM·min) in participants with and without exercise intolerance

  15. Change in coagulation biomarker - Fibrinolysis assay

    Time frame: At diagnosis, 3 months and 12 months post-diagnosis

    Measure coagulation biomarker fibrinolysis assay (unit of measure: % lysis) in participants with and without exercise intolerance

Sponsors and collaborators

Lead sponsor

University of Texas Southwestern Medical Center

Other

Registry information

Official study title

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

Important dates

Study start
2020
Primary completion
2026
Study completion
2027
First posted
Oct 12, 2020
Registry last updated
Jun 8, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.