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
1 other identifier
observational
115
1 country
14
Brief Summary
This is a multi-center prospective cohort study of patients with first-episode deep venous thrombosis and pulmonary embolism.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Dec 2020
Longer than P75 for all trials
14 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
September 22, 2020
CompletedFirst Posted
Study publicly available on registry
October 12, 2020
CompletedStudy Start
First participant enrolled
December 22, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2026
ExpectedStudy Completion
Last participant's last visit for all outcomes
December 1, 2026
February 2, 2026
January 1, 2026
5.4 years
September 22, 2020
January 29, 2026
Conditions
Outcome Measures
Primary Outcomes (2)
Change in exercise capacity
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)
3 months and 12 months post-diagnosis
Change in dyspnea on exertion (DOE)
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
3 months and 12 months post-diagnosis
Secondary Outcomes (15)
Change in cardiac maladaptation
3 months and 12 months post-diagnosis
Change in pulmonary/ventilatory limitations
3 months and 12 months post-diagnosis
Change in muscle metabolic aberrations
3 months and 12 months post-diagnosis
Change in pulmonary vascular obstruction score in participants with and without exercise intolerance (Quantitative assessment)
At diagnosis, 3 months and 12 months post-diagnosis
Change in pulmonary vascular obstruction score in participants with and without exercise intolerance (Qualitative assessment)
At diagnosis, 3 months and 12 months post-diagnosis
- +10 more secondary outcomes
Study Arms (2)
Participants with Pulmonary Embolism
The target accrual is based on the primary endpoint (exercise intolerance and dyspnea on exertion). To achieve adequate power and precision in the primary analysis, the target enrollment is 80 children. Both males and females of all races and ethnic groups are eligible for this study.
Control Group
A positive control group that has not had pulmonary embolism (PE) but is prescribed physical activity restrictions expected to produce a similar deconditioning effect as patients with PE will be enrolled from UT Southwestern only (cohort 1) or children who are no prescribed physical activity restrictions and are otherwise considered healthy (cohort 2). The target accrual of the positive control group is based on feasibility and availability of funds and will be limited to 25 controls.
Interventions
Labs will be drawn at Visit 1, also referred to as screening (within 60 days of diagnosis) with the standard of care labs drawn.
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.
Eligibility Criteria
Study population will include children (defined as persons who have not attained the legal age for consent to treatments or procedures involved in the research, under the applicable law of the jurisdiction in which the research will be conducted), and patients (defined as individuals in a clinical setting with whom there is a treatment relationship). Participants must meet the eligibility criteria in order to participate in this trial.
You may qualify if:
- 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.
You may not qualify if:
- 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
- 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
- Lack of anticoagulant treatment for the acute VTE due to contraindications
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (14)
Arkansas Childrens Research Institute (ACRI)
Little Rock, Arkansas, 72202, United States
Johns Hopkins All Childrens Hospital
St. Petersburg, Florida, 33701, United States
Emory University / Children's Heathcare Atlanta
Atlanta, Georgia, 30329, United States
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611, United States
Boston Children's Hospital
Boston, Massachusetts, 02115, United States
Central Michigan University
Mount Pleasant, Michigan, 48859, United States
Childrens Mercy Hospital
Kansas City, Missouri, 64108, United States
Cincinnati Childrens Hospital
Cincinnati, Ohio, 45229, United States
Nationwide Children's Hospital
Columbus, Ohio, 43205, United States
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104, United States
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19146, United States
UT Southwestern Medical Center / Children's Medical Center
Dallas, Texas, 75235, United States
Cook Childrens Medical Center
Fort Worth, Texas, 76104, United States
Texas Children's Hospital
Houston, Texas, 77030, United States
Related Links
Biospecimen
Research Biomarkers: blood for inflammatory markers, thrombin generation and fibrinolysis assays are required for all participants. Research Blood for DNA/RNA only collected for those participants who consent to genetic material.
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Ayesha Zia, MD, MSCS
University of Texas Southwestern Medical Center
Study Design
- Study Type
- observational
- Observational Model
- CASE CONTROL
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Associate Professor of Pediatrics
Study Record Dates
First Submitted
September 22, 2020
First Posted
October 12, 2020
Study Start
December 22, 2020
Primary Completion (Estimated)
June 1, 2026
Study Completion (Estimated)
December 1, 2026
Last Updated
February 2, 2026
Record last verified: 2026-01