Lymphatic InsufficiencyLYMTRIVANCT04595448
Lymphatic Function in Patients With Secondary Tricuspid Valve Regurgitation
An observational study of Lymphatic Insufficiency and Heart Failure, run by University of Aarhus at 1 site in Denmark.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Lymphatic Insufficiency, Heart Failure, Edema
- How many people
- 18 participants
- Where
- 1 siteDenmark
- Study dates
- 15 Sep 2020to 15 Nov 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients with moderate to severe tricuspid regurgitation and healthy, age, gender, and weight-matched controls
Who may be able to join
- Patients with moderate to severe tricuspid regurgitation
- Age ≥18 years
- Informed consent
- Healthy
- Age ≥18 years
- Age, gender and weight matched with included patients.
Who cannot join
- Reduced ejection fraction (<50%)
- Congenital heart disease
- Left sided valve disease
- MRI contraindications (All metal implants, cochlear implants, pacemakers etc.)
- Claustrophobia
- Peripheral edema
Show all 15Show fewer
- BMI>30
- Age<18.
- Controls:
- Cardiovascular disease
- MRI contraindications (All metal implants, cochlear implants, pacemakers etc.)
- Claustrophobia
- Peripheral edema
- BMI>30
- Age<18.
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Cardiothoracic Surgery
Aarhus N, Central Jutland, 8200
About this study
Official title: 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.
Read the 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.
- Conditions
- Lymphatic Insufficiency, Heart Failure, Edema
- Medical subject headings
- Heart Failure, Edema
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Patients | Patients suffering from moderate tricuspid valve regurgitation | |
| Controls | Cardiovascular healthy, age, gender and weight matched controls. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Thoracic duct tortuosity (centimeters/centimeters)
Based on MRI, the thoracic duct will be rendered and measured with regards to tortuosity (full length/straight length)
Measured: 20 minutes
Thoracic duct volume (cubic centimetres)
Based on MRI, the thoracic duct will be rendered and measured with regards to volume.
Measured: 30 minutes
Excess fluid (yes/no)
Based on MRI, the existence of excess fluid in the pericardial, thoracic and abdominal cavity will be accessed.
Measured: 40 minutes
Peripheral lymphatic velocity (centimeters/second)
Peripheral lymphatic fluid velocity (centimeters/second) will be calculated based upon NIRF sequences.
Measured: 1 hour
Peripheral lymphatic frequency (contractions/minute)
Peripheral lymphatic contraction frequency (contractions/minute) will be calculated based upon NIRF sequences.
Measured: 1 hour 30 minutes
Secondary outcomes (1)
Capillary filtration
Evaluation of capillary filtration rate estimated using plethysmography
Measured: 2 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2020
- Study start15 Sep 2020
- Primary completion15 Nov 2022
- Study completion15 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lymphatic InsufficiencyStudies of the same condition, open and under way.
- More trials run by University of AarhusThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Aarhus
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04595448
- Sponsor's protocol ID
- 1-10-72-113-20
- Acronym
- LYMTRIVA
- Status last verified
- May 2022
- First submitted
- 18 Sep 2020
- Last updated
- 18 Jun 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lymphatic Function in Patients With Secondary Tricuspid Valve Regurgitation - An Unknown Collaborator in a System Under Pressure
- ClinicalTrials.gov ID
- NCT04595448
- Acronym / sponsor ID
- LYMTRIVA / 1-10-72-113-20
- Conditions
- Lymphatic Insufficiency, Heart Failure, Edema
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- University of AarhusUniversity, hospital or other
- Study start
- 15 Sep 2020 (actual)
- Primary completion
- 15 Nov 2022 (actual)
- Study completion
- 15 Nov 2022 (actual)
- First posted
- 20 Oct 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Patients | – | –Patients suffering from moderate tricuspid valve regurgitation |
| Controls | – | –Cardiovascular healthy, age, gender and weight matched controls. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with moderate to severe tricuspid regurgitation and healthy, age, gender, and weight-matched controls
Key inclusion criteria (6 listed)
- Patients with moderate to severe tricuspid regurgitation
- Age ≥18 years
- Informed consent
- Healthy
- Age ≥18 years
Key exclusion criteria (15 listed)
- Reduced ejection fraction (<50%)
- Congenital heart disease
- Left sided valve disease
- MRI contraindications (All metal implants, cochlear implants, pacemakers etc.)
- Claustrophobia
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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)
Thoracic duct volume (cubic centimetres)
Time frame: 30 minutes
Based on MRI, the thoracic duct will be rendered and measured with regards to volume.
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.
Peripheral lymphatic velocity (centimeters/second)
Time frame: 1 hour
Peripheral lymphatic fluid velocity (centimeters/second) will be calculated based upon NIRF sequences.
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 secondary outcome
Capillary filtration
Time frame: 2 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Lymphatic Insufficiency and Heart Failure, run by University of Aarhus at 1 site in Denmark.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jun 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Denmark. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Thoracic duct tortuosity (centimeters/centimeters) (time frame: 20 minutes). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2023.