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Completed

NCT Number: NCT04595448

Lymphatic Function in Patients With Secondary Tricuspid Valve Regurgitation

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.

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Key information

Conditions

Lymphatic Insufficiency Cardiovascular Diseases Edema Heart Diseases Heart Failure Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Department of Cardiothoracic Surgery

Aarhus N, Central Jutland, 8200, Denmark

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  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 outcomes

  1. Capillary filtration

    Time frame: 2 hours

    Evaluation of capillary filtration rate estimated using plethysmography

Sponsors and collaborators

Lead sponsor

University of Aarhus

Other

Registry information

Official study title

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

Acronym: LYMTRIVA

Important dates

Study start
2020
Primary completion
2022
Study completion
2022
First posted
Oct 20, 2020
Registry last updated
Jun 18, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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