Lymphatic Function in Patients With Secondary Tricuspid Valve Regurgitation

Completed

• Conditions: Lymphatic Insufficiency; Edema; Heart Failure

• Registration Number: NCT04595448
• Lead Sponsor: University of Aarhus

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2020-09-15
• Study First Submitted: 2020-09-18
• Study First Submitted QC: 2020-10-19
• Study First Posted: 2020-10-20
• Status Verified: 2022-05
• Primary Completion: 2022-11-15
• Study Completion: 2022-11-15
• Last Update Submitted: 2023-06-15
• Last Update Posted: 2023-06-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Thoracic duct volume (cubic centimetres)	30 minutes	Based on MRI, the thoracic duct will be rendered and measured with regards to volume.
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)
Excess fluid (yes/no)	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)	1 hour	Peripheral lymphatic fluid velocity (centimeters/second) will be calculated based upon NIRF sequences.
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

Name	Time	Method
Capillary filtration	2 hours	Evaluation of capillary filtration rate estimated using plethysmography

Trial Locations

Locations (1)

Department of Cardiothoracic Surgery; 🇩🇰 Aarhus N, Central Denmark Region, Denmark