Lymphatic Function in Patients With Secondary Tricuspid Valve Regurgitation (LYMTRIVA)

June 15, 2023 updated by: University of Aarhus

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

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.

Study Overview

Status

Completed

Conditions

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.

Study Type

Observational

Enrollment (Actual)

18

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Denmark
    • Central Denmark Region
      • Aarhus N, Central Denmark Region, Denmark, 8200
        • Department of Cardiothoracic Surgery

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

Patients with moderate to severe tricuspid regurgitation and healthy, age, gender, and weight-matched controls

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Patients
Patients suffering from moderate tricuspid valve regurgitation
Controls
Cardiovascular healthy, age, gender and weight matched controls.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
20 minutes
Thoracic duct volume (cubic centimetres)
Time Frame: 30 minutes
Based on MRI, the thoracic duct will be rendered and measured with regards to volume.
30 minutes
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.
40 minutes
Peripheral lymphatic velocity (centimeters/second)
Time Frame: 1 hour
Peripheral lymphatic fluid velocity (centimeters/second) will be calculated based upon NIRF sequences.
1 hour
Peripheral lymphatic frequency (contractions/minute)
Time Frame: 1 hour 30 minutes
Peripheral lymphatic contraction frequency (contractions/minute) will be calculated based upon NIRF sequences.
1 hour 30 minutes

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Capillary filtration
Time Frame: 2 hours
Evaluation of capillary filtration rate estimated using plethysmography
2 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aarhus

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 15, 2020

Primary Completion (Actual)

November 15, 2022

Study Completion (Actual)

November 15, 2022

Study Registration Dates

First Submitted

September 18, 2020

First Submitted That Met QC Criteria

October 19, 2020

First Posted (Actual)

October 20, 2020

Study Record Updates

Last Update Posted (Estimated)

June 16, 2023

Last Update Submitted That Met QC Criteria

June 15, 2023

Last Verified

May 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 1-10-72-113-20

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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