Lymphatic Function in Patients With Secondary Tricuspid Valve Regurgitation

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT04595448

Acronym

LYMTRIVA

Enrollment

Registered

2020-10-20

Start date

2020-09-15

Completion date

2022-11-15

Last updated

2023-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Edema, Heart Failure, Lymphatic Insufficiency

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Yes

Inclusion 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.

Design outcomes

Primary

Measure	Time frame	Description
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)
Thoracic duct volume (cubic centimetres)	30 minutes	Based on MRI, the thoracic duct will be rendered and measured with regards to volume.
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

Measure	Time frame	Description
Capillary filtration	2 hours	Evaluation of capillary filtration rate estimated using plethysmography

Countries

Denmark

Outcome results