The FUVID Study

Functional Characterization of Children with Chronic Venous Thromboembolic Disease

[ClinicalTrials.gov Identifier: NCT04583878 ]

A multi-center, prospective study evaluating exercise intolerance and dyspnea on exertion in patients following first-episode deep venous thrombosis and pulmonary embolism

About the FUVID Study

A patient’s daily life after he/she survives blood clots in the lungs or legs is not often the same as before.

After experiencing blood clots in the lungs or legs, there may be incomplete physical recovery. Many children and young adults experience exercise intolerance and shortness of breath.

We don’t know why these physical complications happen after blood clots, but we want to study whether the heart, lungs, or muscles might be at play.

We want to research and develop treatments for these problems. That’s why we need your participation in this study.

The FUVID Study is currently open for enrollment to qualified participants.

How will this study benefit me?

 

By participating in this study, you will receive test results and detailed information regarding your body composition, lung functionality, exercise tolerance (or exercise capacity) and cardiac and lung imaging.

There is no guarantee or promise that you will receive any benefit from this study or from knowing the results of the research conducted.

You can participate in this study as a study or control participant.

Patients who have a blood clot in the lungs are called study participants. Those who have not had a blood clot are control participants. The investigators also want to find out if the way heart and lung function when you exercise is different between the study and control participants.

 

You are eligible as a study participant if all of these are true:

  • You have had a blood clot or pulmonary embolism in your lungs that:

  • Affected the right side of your heart

  • Caused your blood pressure to drop

  • Caused you to collapse at diagnosis (also called intermediate-risk or high-risk pulmonary embolism)

  • You are between 8-21 years of age

  • You are willing to participate and able to comply with the study protocol

 

You are eligible as a control participant if all of these are true:

  • You have been asked to limit your activity for at least 4 weeks (but no more than 12 weeks) following minor surgery or injury

 

You are not eligible as a study or control participant if any of these are true:

  • If you have had a blood clot

  • In the past (blood clots as an infant do not count) as a result of cancer

  • If you have any of the following conditions:

    • Uncontrolled asthma, or you experience asthma symptoms daily (despite being on medication)

    • Heart problems which have caused blood clots (and you are under the care of a pediatric cardiologist)

    • Chronic kidney disease

    • Chronic inflammatory or an autoimmune disorder (systemic lupus erythematosus, juvenile rheumatoid disorder, inflammatory bowel disease or sickle cell disease)

    • Metabolic or endocrinological disorder (such as diabetes mellitus or thyroid disorder)

    • Contraindications to magnetic resonance imaging (MRI)

  • If you are not allowed to exercise for 4 months following the diagnosis of your most recent blood clot

  • If you are pregnant or are planning on becoming pregnant

  • You weigh 300 pounds or more

  • You did not receive blood thinners for the current blood clot (only for study participants)

What happens if I decide to join the research study?

The FUVID study will compensate you for your time and related expenses, including travel to Dallas, TX, hotel stay, meals, and transportation between airport, hotel, and Children’s Medical Center. For participants who are minors, costs associated with one parent or legal guardian will also be covered.

  • Visit 1 will occur within 4 weeks of the diagnosis of your blood clot (study participant) or 4 weeks following minor surgery or injury (control participant).

    It may occur while you are in the hospital or be combined with your doctor appointment (especially if your doctor is part of our study) (everyone)

    You will be asked to:

    • Fill out electronic questionnaires (everyone)

    • Provide blood specimens (only for study participant and based on location)

  • Visit 2 will be a research visit that will be scheduled within 2-3 months after Visit 1.

    You will be required to visit Children’s Medical Center located in Dallas, Texas (may require overnight hotel stay).

    Research will be conducted over 3 consecutive days in order to complete all necessary procedures.

    During your appointments, you will:

    • Fill out additional questionnaires

    • Perform an exercise test (stationary bicycle)

    • Perform lung function tests

    • Take an MRI of your lungs, heart and legs

    • Provide additional blood specimens

  • Visit 3 will be a research visit that will be scheduled within 9-10 months after Visit 2.

    You will be required to visit Children’s Medical Center located in Dallas, Texas (may require overnight hotel stay).

    Research will be conducted over 3 consecutive days in order to complete all necessary procedures.

    During your appointments, you will:

    • Fill out additional questionnaires

    • Perform an exercise test (stationary bicycle)

    • Perform lung function tests

    • Take an MRI of your lungs, heart and legs

    • Provide additional blood specimens

 

Questions?

To learn more about participation or eligibility, please email the study team: FUVID@UTSouthwestern.edu.

If you are interested in participating, please complete our short, confidential survey by clicking the button below.

If you meet the eligibility criteria, you will be contacted by the study team for further assessment.

FUVID Study Team

  • Ayesha Zia, MD, MSCS

    Principal Investigator
    Associate Professor of Pediatrics
    UT Southwestern Medical Center

  • Kendra Malone, MPH CCRP

    Research Coordinator
    Children's Health

  • Anna Winborn, CCRC

    Research Coordinator
    Children's Health

  • Lorrie Burkhalter, MPH, CCRC

    Program Manager
    UT Southwestern Medical Center

Funded By

  • National Institutes of Health (NIH) Logo

    National Institutes of Health (NIH)

  • American Heart Association (AHA) logo

    American Heart Association (AHA)

More About Us

  • Principal Investigator
    Ayesha Zia, MD, MSCS
    Pediatric Hematology Oncology
    Associate Professor of Pediatrics
    The University of Texas Southwestern

    Lead Sub-Investigator(s)
    Jessica Garcia, MD
    Pediatric Hematology Oncology
    Assistant Professor of Pediatrics
    The University of Texas Southwestern

    Co-Investigator(s)

    Tony Babb, PhD
    Professor of Pulmonology
    The Institute of Exercise and Environmental Medicine

    Michael Nelson, PhD
    Associate Professor of Kinesiology
    The University of Texas Southwestern

    M. Tarique Hussain, MD, PhD
    Associate Professor of Pediatric Cardiology
    The University of Texas Southwestern

    Jimin Ren, PhD
    Associate Professor of Imaging
    The University of Texas Southwestern

    Robert Mattrey, MD
    Professor of Radiology
    The University of Texas Southwestern

    Biostatistician

    Song Zhang, PhDAssociate Professor of BiostatisticsThe University of Texas Southwester

  • Learn more about the Pauline Allen Gill Center for Cancer and Blood Disorders (CCBD).

    Learn more about UT Southwestern Pediatric Group.

  • Learn more about Children's Medical Center Dallas.

  • Learn more about UT Southwestern Pediatric Group.