LYMTRIVA: Lymphatic Function in Patients With Secondary Tricuspid Valve Regurgitation

Sponsor
University of Aarhus (Other)
Overall Status
Active, not recruiting
CT.gov ID
NCT04595448
Collaborator
(none)
32
1
36
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Study Details

Study Description

Brief Summary

The study will examine the lymphatic functional and morphological status in patients with moderate tricuspid valve regurgitation compared to healthy age and gender-matched controls.

The study will use t2 weighted MRI, Near-infrared fluorescence imaging, and plethysmography to examine the above-mentioned question.

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    The study will examine the lymphatic functional and morphological status in patients with moderate tricuspid valve regurgitation compared to healthy age and gender-matched controls.

    Subjects will be examined at one occasion using t2-weighted MRIs to evaluated lymphatic anatomy and Near-infrared fluorescence imaging for evaluation of superficial peripheral lymphatic function. Finally, the capillary filtration rate will be estimated using plethysmography.

    Study Design

    Study Type:
    Observational
    Anticipated Enrollment :
    32 participants
    Observational Model:
    Case-Control
    Time Perspective:
    Prospective
    Official Title:
    Lymphatic Function in Patients With Secondary Tricuspid Valve Regurgitation - An Unknown Collaborator in a System Under Pressure
    Actual Study Start Date :
    Sep 15, 2020
    Anticipated Primary Completion Date :
    Sep 15, 2022
    Anticipated Study Completion Date :
    Sep 15, 2023

    Arms and Interventions

    Arm Intervention/Treatment
    Patients

    Patients suffering from moderate tricuspid valve regurgitation

    Controls

    Cardiovascular healthy, age, gender and weight matched controls.

    Outcome Measures

    Primary Outcome Measures

    1. Thoracic duct tortuosity (centimeters/centimeters) [20 minutes]

      Based on MRI, the thoracic duct will be rendered and measured with regards to tortuosity (full length/straight length)

    2. Thoracic duct volume (cubic centimetres) [30 minutes]

      Based on MRI, the thoracic duct will be rendered and measured with regards to volume.

    3. Excess fluid (yes/no) [40 minutes]

      Based on MRI, the existence of excess fluid in the pericardial, thoracic and abdominal cavity will be accessed.

    4. Peripheral lymphatic velocity (centimeters/second) [1 hour]

      Peripheral lymphatic fluid velocity (centimeters/second) will be calculated based upon NIRF sequences.

    5. Peripheral lymphatic frequency (contractions/minute) [1 hour 30 minutes]

      Peripheral lymphatic contraction frequency (contractions/minute) will be calculated based upon NIRF sequences.

    Secondary Outcome Measures

    1. Capillary filtration [2 hours]

      Evaluation of capillary filtration rate estimated using plethysmography

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Patients:
    Inclusion criteria:
    • Patients with moderate to severe tricuspid regurgitation

    • Age ≥18 years

    • Informed consent

    Exclusion criteria:
    • Reduced ejection fraction (<50%)

    • Congenital heart disease

    • Left sided valve disease

    • MRI contraindications (All metal implants, cochlear implants, pacemakers etc.)

    • Claustrophobia

    • Peripheral edema

    • BMI>30

    • Age<18.

    Controls:
    Inclusion criteria:
    • Healthy

    • Age ≥18 years

    • Age, gender and weight matched with included patients.

    Exclusion criteria:
    • Cardiovascular disease

    • MRI contraindications (All metal implants, cochlear implants, pacemakers etc.)

    • Claustrophobia

    • Peripheral edema

    • BMI>30

    • Age<18.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Department of Cardiothoracic Surgery Aarhus N Central Denmark Region Denmark 8200

    Sponsors and Collaborators

    • University of Aarhus

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    University of Aarhus
    ClinicalTrials.gov Identifier:
    NCT04595448
    Other Study ID Numbers:
    • 1-10-72-113-20
    First Posted:
    Oct 20, 2020
    Last Update Posted:
    May 18, 2022
    Last Verified:
    May 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:

    Study Results

    No Results Posted as of May 18, 2022