Deep Venous ThrombosisNCT04583878
FUVID Study: Functional Characterization of Children With Chronic Venous Thromboembolic Disease
An observational study of Deep Venous Thrombosis and Pulmonary Embolism, run by University of Texas Southwestern Medical Center at 14 sites in United States.
Trial summary
This is a multi-center prospective cohort study of patients with first-episode deep venous thrombosis and pulmonary embolism. Read more about this study
- Who is it for?
- Ages 8 to 21 yearsHealthy volunteers can take part
- Conditions the study is for
- Deep Venous Thrombosis, Pulmonary Embolism
- What is being tested?
- Blood draw (Visit 1) and Blood draw (Visits 2 and 3)
- How many people
- 115 participants
- Where
- 14 sitesUnited States
- Study dates
- 22 Dec 2020to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 8 to 21 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Study population: 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.
Who may be able to join
- 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.
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
United States14 sites
Emory University / Children's Heathcare Atlanta
Atlanta, Georgia, 30329
Boston Children's Hospital
Boston, Massachusetts, 02115
Ann & Robert H. Lurie Children's Hospital of Chicago
Chicago, Illinois, 60611
Cincinnati Childrens Hospital
Cincinnati, Ohio, 45229
Nationwide Children's Hospital
Columbus, Ohio, 43205
UT Southwestern Medical Center / Children's Medical Center
Dallas, Texas, 75235
Cook Childrens Medical Center
Fort Worth, Texas, 76104
Texas Children's Hospital
Houston, Texas, 77030
Childrens Mercy Hospital
Kansas City, Missouri, 64108
Arkansas Childrens Research Institute (ACRI)
Little Rock, Arkansas, 72202
Central Michigan University
Mount Pleasant, Michigan, 48859
University of Oklahoma Health Sciences Center
Oklahoma City, Oklahoma, 73104
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19146
Johns Hopkins All Childrens Hospital
St. Petersburg, Florida, 33701
About this study
Official 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
This is a multi-center prospective cohort study of patients with first-episode deep venous thrombosis and pulmonary embolism.
Read the 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
- Being tested
- Blood draw (Visit 1), Blood draw (Visits 2 and 3)
- Medical subject headings
- Venous Thrombosis, Pulmonary Embolism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Diagnostic Test: Blood draw (Visit 1); Diagnostic Test: Blood draw (Visits 2 and 3) | |
| 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. Receives: Diagnostic Test: Blood draw (Visits 2 and 3) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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
Measured: 3 months and 12 months post-diagnosis
Secondary outcomes (15)
Change in cardiac maladaptation
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)
Measured: 3 months and 12 months post-diagnosis
Change in pulmonary/ventilatory limitations
Measured as VE/VCO2 in participants with and without exercise intolerance during cardiopulmonary testing
Measured: 3 months and 12 months post-diagnosis
Change in muscle metabolic aberrations
Measured by % phosphocreatine (PCr) depletion (Δ %PCr) during exercise using 31P magnetic resonance spectroscopy on 7 Tesla in participants with and without exercise intolerance
Measured: 3 months and 12 months post-diagnosis
Change in pulmonary vascular obstruction score in participants with and without exercise intolerance (Quantitative assessment)
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.
Measured: At diagnosis, 3 months and 12 months post-diagnosis
Change in pulmonary vascular obstruction score in participants with and without exercise intolerance (Qualitative assessment)
Qualitative Assessment: Measured using pulmonary perfusion maps at diagnosis, 3 and 12 months post-diagnosis. Since qualitative, there are no minimum or maximum values.
Measured: At diagnosis, 3 months and 12 months post-diagnosis
Change in calf muscle perfusion and venous flow in participants with and without exercise intolerance and between affected and non-affected extremity
Measured using extremity arterial spin labelling on 7 Tesla MRI
Measured: 3 months and 12 months post-diagnosis
Change in dyspnea ratings using Dalhousie Pictorial Scale
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)
Measured: 3 months and 12 months post-diagnosis
Change in dyspnea ratings using Borg Dyspnea Scale
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)
Measured: 3 months and 12 months post-diagnosis
Change in dyspnea ratings using Dyspnoea-12 Scale
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)
Measured: 3 months and 12 months post-diagnosis
Change in dyspnea ratings using Modified Medical Research Council Dyspnea Scale
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)
Measured: 3 months and 12 months post-diagnosis
Change in inflammatory cytokine biomarker - High-sensitivity CRP
Measure inflammatory cytokine biomarker high-sensitivity CRP (unit of measure: mg/L) in participants with and without exercise intolerance
Measured: At diagnosis, 3 months and 12 months post-diagnosis
Change in inflammatory cytokine biomarkers - IL-6 and TNF
Measure inflammatory cytokine biomarkers IL-6 and TNF-α (unit of measure: pg/mL) in participants with and without exercise intolerance
Measured: At diagnosis, 3 months and 12 months post-diagnosis
Change in coagulation biomarker - D-dimer
Measure coagulation biomarker D-dimer (unit of measure: ng/mL) in participants with and without exercise intolerance
Measured: At diagnosis, 3 months and 12 months post-diagnosis
Change in coagulation biomarker - Thrombin generation
Measure coagulation biomarker thrombin generation (unit of measure: nM·min) in participants with and without exercise intolerance
Measured: At diagnosis, 3 months and 12 months post-diagnosis
Change in coagulation biomarker - Fibrinolysis assay
Measure coagulation biomarker fibrinolysis assay (unit of measure: % lysis) in participants with and without exercise intolerance
Measured: At diagnosis, 3 months and 12 months post-diagnosis
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Oct 2020
- Study start22 Dec 2020
- Primary completion11 Mar 2026
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Deep Venous ThrombosisStudies of the same condition, open and under way.
- More trials run by University of Texas Southwestern Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 115 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Texas Southwestern Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ayesha Zia, University of Texas Southwestern Medical Center
- Investigators
- Ayesha Zia, MD, MSCS, Principal investigator, University of Texas Southwestern Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04583878
- Sponsor's protocol ID
- STU-2020-0868
- Status last verified
- Jun 2026
- First submitted
- 22 Sep 2020
- Last updated
- 8 Jun 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official 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
- ClinicalTrials.gov ID
- NCT04583878
- Acronym / sponsor ID
- STU-2020-0868
- Conditions
- Deep Venous Thrombosis, Pulmonary Embolism
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 115 participants (actual)
- Lead sponsor
- University of Texas Southwestern Medical CenterUniversity, hospital or other
- Study start
- 22 Dec 2020 (actual)
- Primary completion
- 11 Mar 2026 (actual)
- Study completion
- Mar 2027 (estimated)
- First posted
- 12 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Participants with Pulmonary Embolism | – | Diagnostic Test: Blood draw (Visit 1), Diagnostic Test: Blood draw (Visits 2 and 3)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 | – | Diagnostic Test: Blood draw (Visits 2 and 3)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. |
Who may qualify
- Ages
- 8 to 21 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
- Study population
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Participants with Pulmonary Embolism |
| 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. | Diagnostic test | Control Group, Participants with Pulmonary Embolism |
Primary outcome
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)
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
15 secondary outcomes
Change in cardiac maladaptation
Time frame: 3 months and 12 months post-diagnosis
Change in pulmonary/ventilatory limitations
Time frame: 3 months and 12 months post-diagnosis
Change in muscle metabolic aberrations
Time frame: 3 months and 12 months post-diagnosis
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
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
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
Change in dyspnea ratings using Dalhousie Pictorial Scale
Time frame: 3 months and 12 months post-diagnosis
Change in dyspnea ratings using Borg Dyspnea Scale
Time frame: 3 months and 12 months post-diagnosis
Change in dyspnea ratings using Dyspnoea-12 Scale
Time frame: 3 months and 12 months post-diagnosis
Change in dyspnea ratings using Modified Medical Research Council Dyspnea Scale
Time frame: 3 months and 12 months post-diagnosis
Change in inflammatory cytokine biomarker - High-sensitivity CRP
Time frame: At diagnosis, 3 months and 12 months post-diagnosis
Change in inflammatory cytokine biomarkers - IL-6 and TNF
Time frame: At diagnosis, 3 months and 12 months post-diagnosis
Change in coagulation biomarker - D-dimer
Time frame: At diagnosis, 3 months and 12 months post-diagnosis
Change in coagulation biomarker - Thrombin generation
Time frame: At diagnosis, 3 months and 12 months post-diagnosis
Change in coagulation biomarker - Fibrinolysis assay
Time frame: At diagnosis, 3 months and 12 months post-diagnosis
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jun 2026.
- FUVID WebsiteLink provided by the sponsor.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ayesha Zia, MD, MSCS principal investigator
University of Texas Southwestern Medical Center
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Deep Venous Thrombosis and Pulmonary Embolism, run by University of Texas Southwestern Medical Center at 14 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 8 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in exercise capacity (time frame: 3 months and 12 months post-diagnosis). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Jun 2026.