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Lymphatic Function in Patients With Secondary Tricuspid Valve Regurgitation (LYMTRIVA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04595448
Recruitment Status : Active, not recruiting
First Posted : October 20, 2020
Last Update Posted : May 18, 2022
Sponsor:
Information provided by (Responsible Party):
University of Aarhus

Study Description
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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
Lymphatic Insufficiency Heart Failure Edema

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
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Study Type : Observational
Estimated 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 : September 15, 2020
Estimated Primary Completion Date : September 15, 2022
Estimated Study Completion Date : September 15, 2023
Groups and Cohorts
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Group/Cohort
Patients
Patients suffering from moderate tricuspid valve regurgitation
Controls
Cardiovascular healthy, age, gender and weight matched controls.


Outcome Measures
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Primary Outcome Measures :
  1. Thoracic duct tortuosity (centimeters/centimeters) [ Time Frame: 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) [ Time Frame: 30 minutes ]
    Based on MRI, the thoracic duct will be rendered and measured with regards to volume.

  3. Excess fluid (yes/no) [ Time Frame: 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) [ Time Frame: 1 hour ]
    Peripheral lymphatic fluid velocity (centimeters/second) will be calculated based upon NIRF sequences.

  5. Peripheral lymphatic frequency (contractions/minute) [ Time Frame: 1 hour 30 minutes ]
    Peripheral lymphatic contraction frequency (contractions/minute) will be calculated based upon NIRF sequences.


Secondary Outcome Measures :
  1. Capillary filtration [ Time Frame: 2 hours ]
    Evaluation of capillary filtration rate estimated using plethysmography


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients with moderate to severe tricuspid regurgitation and healthy, age, gender, and weight-matched controls
Criteria

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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04595448


Locations
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Denmark
Department of Cardiothoracic Surgery
Aarhus N, Central Denmark Region, Denmark, 8200
Sponsors and Collaborators
University of Aarhus
More Information
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Responsible Party: University of Aarhus
ClinicalTrials.gov Identifier: NCT04595448    
Other Study ID Numbers: 1-10-72-113-20
First Posted: October 20, 2020    Key Record Dates
Last Update Posted: May 18, 2022
Last Verified: May 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Tricuspid Valve Insufficiency
Heart Diseases
Cardiovascular Diseases
Heart Valve Diseases