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Clinical Trials/NCT04595448
NCT04595448
Completed
Not Applicable

Lymphatic Function in Patients With Secondary Tricuspid Valve Regurgitation - An Unknown Collaborator in a System Under Pressure

University of Aarhus1 site in 1 country18 target enrollmentSeptember 15, 2020

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Lymphatic Insufficiency
Sponsor
University of Aarhus
Enrollment
18
Locations
1
Primary Endpoint
Thoracic duct volume (cubic centimetres)
Status
Completed
Last Updated
2 years ago

Overview

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.

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.

Registry
clinicaltrials.gov
Start Date
September 15, 2020
End Date
November 15, 2022
Last Updated
2 years ago
Study Type
Observational
Sex
All

Investigators

Responsible Party
Sponsor

Eligibility Criteria

Inclusion Criteria

  • Not provided

Exclusion Criteria

  • Not provided

Outcomes

Primary Outcomes

Thoracic duct volume (cubic centimetres)

Time Frame: 30 minutes

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

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)

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.

Peripheral lymphatic velocity (centimeters/second)

Time Frame: 1 hour

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

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 Outcomes

  • Capillary filtration(2 hours)

Study Sites (1)

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