Lymphatic Function in Patients With Secondary Tricuspid Valve Regurgitation

NCT ID: NCT04595448

Last Updated: 2023-06-18

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

18 participants

Study Classification

OBSERVATIONAL

Study Start Date

2020-09-15

Study Completion Date

2022-11-15

Brief Summary

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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

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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.

Conditions

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Lymphatic Insufficiency Heart Failure Edema

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients

Patients suffering from moderate tricuspid valve regurgitation

No interventions assigned to this group

Controls

Cardiovascular healthy, age, gender and weight matched controls.

No interventions assigned to this group

Eligibility Criteria

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Inclusion Criteria

* Patients with moderate to severe tricuspid regurgitation
* Age ≥18 years
* Informed consent


* Healthy
* Age ≥18 years
* Age, gender and weight matched with included patients.

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:


* Cardiovascular disease
* MRI contraindications (All metal implants, cochlear implants, pacemakers etc.)
* Claustrophobia
* Peripheral edema
* BMI\>30
* Age\<18.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Aarhus

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Department of Cardiothoracic Surgery

Aarhus N, Central Jutland, Denmark

Site Status

Countries

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Denmark

Other Identifiers

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1-10-72-113-20

Identifier Type: -

Identifier Source: org_study_id

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