Lymphatic Function in Patients With Secondary Tricuspid Valve Regurgitation

Heart Failure Clinical Trial

— LYMTRIVA  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04595448
• Other study ID #: 1-10-72-113-20
• Status: Completed
• Start date: September 15, 2020
• Est. completion date: November 15, 2022

Study information

• Verified date: May 2022
• Source: University of Aarhus
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 18
• Est. completion date: November 15, 2022
• Est. primary completion date: November 15, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Edema
• Heart Failure
• Lymphatic Insufficiency
• Tricuspid Valve Insufficiency

Locations

Country	Name	City	State
Denmark	Department of Cardiothoracic Surgery	Aarhus N	Central Denmark Region

Sponsors (1)

Lead Sponsor	Collaborator
University of Aarhus

Country where clinical trial is conducted

Denmark, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Thoracic duct tortuosity (centimeters/centimeters)	Based on MRI, the thoracic duct will be rendered and measured with regards to tortuosity (full length/straight length)	20 minutes
Primary	Thoracic duct volume (cubic centimetres)	Based on MRI, the thoracic duct will be rendered and measured with regards to volume.	30 minutes
Primary	Excess fluid (yes/no)	Based on MRI, the existence of excess fluid in the pericardial, thoracic and abdominal cavity will be accessed.	40 minutes
Primary	Peripheral lymphatic velocity (centimeters/second)	Peripheral lymphatic fluid velocity (centimeters/second) will be calculated based upon NIRF sequences.	1 hour
Primary	Peripheral lymphatic frequency (contractions/minute)	Peripheral lymphatic contraction frequency (contractions/minute) will be calculated based upon NIRF sequences.	1 hour 30 minutes
Secondary	Capillary filtration	Evaluation of capillary filtration rate estimated using plethysmography	2 hours